The decision in In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067 (9th Cir. 2020) (“Booker”), is yet another reminder that multidistrict litigation as it is currently conducted is a fundamentally flawed process, dedicated more to forcing settlements than to any of the goals envisioned by Congress when it passed 28 U.S.C. §1407.  The defendant had a strong preemption defense – particularly for a Class II, non-PMA medical device – but could not get it before an appellate court, due to the lack of a final appealable order, until years later, after having to go through (and lose) a “bellwether” trial.  If the plaintiffs had lost a preemption motion, of course, with a final judgment entered against at least some of them, they would have an immediate right to appeal.  In the Booker case, ongoing MDL settlement pressure continued and was effective to force the resolution of a plethora of claims that were questionable, at best.

The joy of MDLs:  what disfavors plaintiffs is appealable; what disfavors anyone else is negotiable.

The defendant’s preemption argument in Booker was primarily that the FDA’s §510(k) clearance process for the devices in question, which occurred after Congress had revamped and toughened “substantial equivalence” in the Safe Medical Devices Act of 1990, should be preemptive because:  (1) Congress then imposed the same “reasonable assurance of safety and effectiveness” standard on §510(k) devices that was held preemptive in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (more or less the same argument we examined in depth here), and (2) the FDA in clearing these particular devices had in fact imposed numerous device-specific requirements, particularly with respect to their design.

Had that argument succeeded, it would have seriously reshaped the contours of that MDL litigation.  However, the district court rejected it.  See In re Bard IVC Filters Products Liability Litigation, 2017 WL 5625547 (D. Ariz. Nov. 22, 2017), and by the time an appeal was decided three years later, case peculiar circumstances prevented the most significant preemption arguments from being presented, let alone resolved.

Because there is no defense right to appeal critical MDL-wide issues such as preemption, those issues (when a defendant loses) are necessarily filtered through subsequent bellwether trials, assuming the litigation gets that far.  However, in Booker, the bellwether trial verdict in question, while hardly a win, was not a disaster for the defendants:

Four claims were presented to the jury at trial: strict liability design defect, negligent design, strict liability failure to warn, and negligent failure to warn.  The jury found Defendants liable on the negligent failure to warn claim and awarded Plaintiff $1.6 million in compensatory damages and $2 million in punitive damages.

In re Bard IVC Filters Products Liability Litigation, 2018 WL 3037161, at *1 (D. Ariz. June 19, 2018), aff’d, 969 F.3d 1067 (9th Cir. 2020).  The design claims had been the key.  They were the only claims in Booker against which the defendants did not move for summary judgment, 969 F.3d at 1072, but in the bellwether trial, “[t]he jury found for [defendant] on” them.  Id.

Bound by Lohr, Booker followed the Supreme Court’s holding that, interpretation of §360k(a) (the medical device preemption clause in the statute) was “substantially informed” by an FDA regulation “provid[ing] that state requirements are preempted only when the FDA has established ‘specific requirements applicable to a particular device.’”  969 F.3d at 1072 (quoting both Lohr, 518 U.S. at 495 and 21 C.F.R. §808.1(d)).  Riegel, of course, had later concluded “that §808.1(d)(1) can add nothing to our analysis but confusion,” 552 U.S. at 329, but since Riegel did not expressly overrule Lohr and Lohr was more directly applicable to §510(k) devices, Booker applied Lohr.

We further note that Booker did not mention any “presumption against preemption,” and indeed professed to follow Supreme Court precedent that, “[w]hen a federal law contains an express preemption clause, we ‘focus on the plain wording of the clause.’”  969 F.3d at 1073 (quoting two Supreme Court cases).  However, those were merely proud words on a dusty shelf, since the “plain wording” of §360k(a) contains nothing resembling “specific requirements applicable to a particular device.”  Rather, that was a gloss added by the FDA, to which Lohr deferred under the influence of the since-repealed presumption against preemption.  However, that presumption died in Puerto Rico v. Franklin California Tax-Free Trust, ___ U.S. ___, 136 S. Ct. 1938, 1946 (2016) (“because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption”) (citation and quotation marks omitted), and the notion that the FDA could define the scope of preemption of its own organic statute met its demise in PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 n.3 (2011) (“we do not defer to an agency’s ultimate conclusion about whether state law should be pre-empted.”) (citation omitted).  So the entire edifice is shaky.

But it did not fall in Booker – largely because the massive FDA regulatory record that the defendants had assembled concerning their devices was directed against the MDL plaintiffs’ design claims (against which fewer other defenses applied).  Thus:

[Defendant] argues that when the FDA reclassified [the product] . . ., the agency imposed specific requirements in the form of the three special controls applicable to such devices.  The preemption issue in this case therefore turns on whether the special controls constitute “specific requirements applicable to a particular device.”

969 F.3d at 1074 (citation omitted).  Booker “assumed without deciding” that these “special controls” imposed by the FDA “were legally binding.”  Id.  That alone is more consideration than many §510(k) preemption arguments receive.

However, Booker nonetheless found no preemption.  First, it held that, despite the FDA incorporating two guidance documents as “special controls” in its clearance of the device in question, they still did not meet the Lohr/808.1(d)(1) gloss on the express preemption clause because the guidances themselves were not “specific” to the defendant’s device.  “The former applies to 13 different kinds of devices, the latter to 18 kinds.”  969 F.3d at 1074.  Booker held that Lohr required very specific specificity.  “[T]he guidance does not impose “specific requirements applicable to a particular device,” 21 C.F.R. § 808.1(d) (emphasis added). . . .  Instead, it applies generally to every member of the class of intravascular filters.”  Id.

Second, the plaintiff’s loss at trial on his design claims transmogrified on appeal into a win on preemption:

[T]he requirements that the intravascular-filter guidance imposes are not relevant to [plaintiff’s] failure-to-warn claim.  State requirements cannot meaningfully be described as “different from, or in addition to, the specific [FDA] requirements” if the two requirements are not relevant to each other.  21 C.F.R. §808.1(d).

Id. at 1074-75.  While Booker cites §808.1(d) in creating this “relevance” requirement, no cognate of the word “relevant” in fact appeals anywhere in this regulation.  Booker effectively made up a new “relevance” gloss to add to the existing Lohr gloss on the statute’s very different wording – preemption whenever a state requirement is “different from or in addition to” a state requirement.  This is the antithesis of textualism, but it was made possible by the peculiarity of the bellwether result – the jury verdict against the design defect claims, as to which no “relevance” quibbles could have been asserted.

[T]he preemption argument fails because [plaintiff’s] claim rests on an asserted state-law duty to warn of the risks posed by the particular design . . ., and the FDA has not imposed any requirements related to . . . how a device of that design should be labeled.

Id. at 1076.

Thus the defendant in Booker lost the heart of its preemption defense because it won.  The bellwether jury returned a verdict against plaintiff’s design claims, making the preemption argument not “relevant.”  Such is the nature of MDL practice, and why, at a fundamental level, the MDL system is broken.

Another way in which the MDL system is broken is that it encourages far flung courts to contort state law in ways that a state court (or even most federal courts interpreting state law) would never do – almost always to the plaintiff’s advantage to maintain settlement pressure.  That happened twice in Booker.  First, as to warnings, no court applying the law of Georgia, the state in question, had ever extended the duty to warn to include adverse comparisons to the risks of competing products.  Indeed, Georgia courts have rejected analogous duties to warn about risks of competing products.  Davis v. John Crane, Inc., 836 S.E.2d 577, 584 (Ga. App. 2019) (adopting bare metal defense in asbestos litigation); PLIVA, Inc. v. Dement, 780 S.E.2d 735, 743 (Ga. App. 2015) (rejecting innovator liability).  Nonetheless, Booker held that any warning duty not expressly prohibited by Georgia courts would be allowed.  “Georgia has not adopted a categorical prohibition on basing a failure-to-warn claim on the absence of a comparative warning,” so Erie conservatism be damned, “we conclude that the district court correctly allowed the jury to decide the adequacy of the warning here.”  969 F.3d at 1076-77 (citations omitted).

A similar distortion of Georgia law occurred in connection with punitive damages.  Georgia law, as interpreted by Georgia courts, has strongly resisted punitive damages where, as in Booker, the defendant complied with the relevant governmental regulatory scheme.  In Stone Man, Inc. v. Green, 435 S.E.2d 205 (Ga. 1993), the court held that compliance “tend[s] to show that there is no clear and convincing evidence of willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care which would raise the presumption of a conscious indifference to consequences.”  Id. at 206.  Thus compliance with governing standards ordinarily renders punitive damages unobtainable: “[P]unitive damages, the purpose of which is to ‘punish, penalize or deter,’ are, as a general rule, improper where a defendant has adhered to [the relevant] safety regulations.”  Id.  Where a product complies with all applicable regulations and standards, Georgia law supports summary judgment.  See Bryant v. BGHA, Inc., 9 F. Supp.3d 1374, 1396 (M.D. Ga. 2014) (summary judgment under Stone Man; design conformed to industry standards); Taylor v. Mooney Aircraft Corp., 464 F. Supp.2d 439, 448-49 (E.D. Pa. 2006) (same; applying Georgia law), aff’d, 265 F. Appx. 87 (3d Cir. 2008).  Compliance with applicable government standards can only be overcome with “evidence that the manufacturer engaged in a deliberate course of conduct which knowingly endangered those using the product.”  Uniroyal Goodrich Tire Co. v. Ford, 461 S.E.2d 877, 884 (Ga. App. 1995), rev’d in part on other grounds, 476 S.E.2d 565 (Ga. 1996).  Even adverse events involving similar injuries cannot overcome regulatory compliance and permit punitive damages.

There is no evidence that would justify an award of punitive damages in this case.  [Defendant’s product] complied with . . . the relevant regulations promulgated by [the federal government].  Plaintiffs hang their hat on the fact that, prior to [plaintiff’s] injury, [defendant] was aware of 741 [similar] injuries to [product users] from [similar] accidents . . ., but that peg is too wobbly to support punitive damages.

Hernandez v. Crown Equipment Corp., 92 F. Supp.3d 1325, 1356 (M.D. Ga. 2015) (footnotes omitted).  See Mims v. Wright Medical Technology, Inc., 2012 WL 1681810, at *5 (N.D. Ga. May 11, 2012) (summary judgment under Stone Man against warning-based punitive damages claim); In re Stand ‘N Seal, Products Liability Litigation, 2009 WL 2145911, at *9 (N.D. Ga. July 15, 2009) (same despite compliant recall plan’s later apparent inadequacy); Welch v. General Motors Corp., 949 F. Supp. 843, 845 (N.D. Ga. 1996) (same; despite similar problems with other vehicles).

In Booker, all this law went by the wayside as supposedly “derivative of [defendant’s] argument that it had no duty to warn of comparative risks.”  969 F.3d at 1077.  Inadequacy of the warning alone was enough to sustain punitive damages under Booker’s perfunctory reading of Georgia law:

[T]he jury found that the warning was not adequate.  As the district court explained, “[t]he evidence supported a finding that despite knowing that [its product] placed patients at a greater risk of harm” than other available filters, “[Defendant] chose not to warn physicians and instead downplayed the risk.”  Although it would have been possible for the jury “to draw a contrary conclusion,” we conclude that the evidence was adequate to support the jury’s award of punitive damages.

Id. (citation omitted).  No aggravating conduct is mentioned in Booker, only the alleged failure to comply with the disputed “duty” to warn about comparative risks of other products.  Booker thus reduced the strong Georgia compliance defense to punitive damages to a nullity.  No Georgia court, subject to review by Georgia appellate courts, would have made such a ruling.  Once again the pressure to affirm a “bellwether” verdict in an MDL has led to state law being bulldozed in order to give plaintiffs another tool with which to leverage settlement.

For all these reasons, Booker is another poster child for what is wrong with the current MDL system.

Uncertainty plagues American litigation and accounts for the frequent analogy to a lottery. The same case tried before two different juries will produce two very different results. Within the same jurisdiction, a plaintiff might ring the bell this week, but get zeroed out the next. Factor in different jurisdictions, and the possibilities will wander all the way across the spectrum. Even accepting that some factual scenarios make a plaintiff verdict nearly inevitable, the range of damages will be panoramic. That is because the standards for fixing certain categories of damages, such as pain and suffering, are hopelessly vague.

No category of damages ratchets up the uncertainties and stakes more than punitive damages. Those awards, despite constitutional limitations, can be eye-wateringly high. (Surely it is significant that SCOTUS recognized that crazy punitive damages awards implicate constitutional rights. Why stop there? Crazy compensatories are just as confiscatory and just as bereft of due process.). The possibility of punitive damages can distort settlement calculations. It is hard to assign value to hot air. A corporate defendant must act rationally in assessing the expected possibilities of irrational awards. It is necessarily a business judgment. That process, applied in the context of risk-aversion and institutional pressures, might lead to overpayments and passing costs along to consumers. From a social perspective, is that a sound outcome? Is it efficient? Is it fair?

We alluded to constitutional limitations, which too often translate into vague and unhelpful caps. Some states do impose concrete caps. Some categories of cases (e.g., antitrust) impose fixed multipliers. Law and economics theory justifies damage multipliers as correcting for the low percentage of detection. That is, if you think there is only a 33% chance you’ll be caught, then a 3x award is necessary to adjust your expectations and incentivize straight and narrow conduct. That’s the theory, anyway. In any event, product liability defendants seldom benefit from such caps. For an industry that invents products that extend and improve lives, drug and medical device companies are curiously unloved.

Let’s be plain about it: the standard for punitive damages in torts is a farce. At first, it sounds as if outrageous, wanton, and malicious conduct should be pretty narrow. If punitive damages were truly limited to cases in which defendants intended harm or acted with utter indifference to anticipated harm, such damages would be out of bounds in most cases. But if you throw in “gross negligence” and throw in judges who grasp hold of any hint of a factual dispute, then you can throw out any meaningful limitation. Almost every case alleging negligence will be permitted to plop punitive damages in front of the jury box. What a mess.

Indiana law is a little bit better in cabining punitive damages than other jurisdictions. Emley v. Walmart Stores, Inc., 2019 WL 2642842 (S.D. Ind. June 27, 2019), offers an example of sanity on the issue of punitive damages. In Emley, the plaintiff claimed she suffered Toxic Epidermal Necrosis TEN) as a result of acetaminophen contained in over the counter (OTC) products she purchased. The defendants moved for summary judgment. Some of the claims were governed by Indiana law. Some were governed by Tennessee law. We will focus on the former,

The defendants argued that the case against them was preempted by PLIVA v. Mensing because the defendants could not unilaterally add a warning regarding TEN. The Emley court concluded that conflict/impossibility preemption did not apply in that case because the OTC products were marketed pursuant to a tentative final monograph, whereas the product in Mensing was marketed pursuant to an ANDA, and a tentative final monograph does not prevent a manufacturer from adding a warning. The Emley court also held that nothing prevented the retailer defendant from adding a warning.

We do not agree with or delight in the preemption part of the Emley case.

But the opinion contained some better things. For instance, the court bounced the plaintiffs’ negligent misrepresentation claim, held that the claims under the Indiana Deceptive Consumer Sales Act were barred by the statute of limitations, and held that the claim under the Indiana Products Liability Act boiled down to failure to warn, so the design defect cause of action had no place in the case.

Our favorite part of Emley relates to punitive damages. Under Indiana law, before a court may award punitive damages “a plaintiff must demonstrate by clear and convincing evidence that the defendant acted with malice, fraud, gross negligence or oppressiveness that was not the result of mistake of fact or law, honest error of judgment, overzealousness, mere negligence, or other human failing.” This standard is not terribly different from many other jurisdictions. But unlike many of those jurisdictions, Indiana courts put some teeth in the standard. Indeed, Indiana courts “have described this consciousness and intention as requiring a show of willful and wanton conduct or a quasi-criminal state of mind.”

The plaintiff in Emley alleged that the manufacturer knew acetaminophen posed a risk of potentially fatal skin reactions such as TEN, that the FDA was encouraging a stronger warning and had approved one for NDA products containing acetaminophen, and yet the manufacturer did nothing for years. It eventually beefed up the warning, but that was too late for this plaintiff The plaintiff also alleged that the manufacturer’s employees regarded the additional warning as an “enhancement,” and continued to sell older products without the enhanced warning even after the warning had been changed. The plaintiff lobbed in testimony by company employees that arguably reflected an indifference to patient safety.

The problem with all this evidence is that it focused on events unrelated to the only act for which the manufacturer could be liable to the plaintiffs —the November 2013 sale of its products to the plaintiffs. Later expressions of indifference, callousness, etc. were irrelevant. As the Emley court put it, summary judgment is a “put up or shut up moment in a lawsuit,” and the plaintiffs had simply failed to put up clear and convincing evidence of relevant conduct warranting punitive damages.

It might be a relatively minor limitation on punitive damages, but at least it is some limitation. Too often, judicial laxity on waving punitive damages issues along to the jury prompts us to think legislative relief is the only answer. Yet every once in a while, a court does its part to shut down the punitive damages lottery ticket machine.

We have expressed our opinion on “failure to update” claims and have not hidden that we don’t think much of them.  Failure to update claims were manufactured by plaintiffs in response to PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) which basically took the legs out from under products liability suits against generic drug manufacturers.  You know what we mean.  Federal law requires that generic drug manufacturers’ products have the same drug labeling and the same design as their innovator (brand) counterparts—the so-called “duty of sameness.”  Therefore, any claims for failure to warn or design defect are preempted by impossibility.

A “failure to update” claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury.  Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  A few courts, however, disagree and have held such claims are not preempted.  In In re: Fluoroquinolone Prods. Liab. Litig., MDL 2642, 2020 WL 6489186 (D. Minn. Nov. 4, 2020), the court said maybe.

The relevant facts are simple.  On August 15, 2013, the FDA issued a Drug Safety Announcement requiring the warnings for all drugs containing fluoroquinolone be updated to “better describe the serious side effect of peripheral neuropathy.”  See https://www.fda.gov/media/86575/download.  In November 2013, plaintiff ingested generic ciprofloxacin and suffered an adverse reaction.  Plaintiff alleges that the generic manufacturer had not updated its label with the warning set forth in the FDA safety announcement at the time she used the drug.  Id. at *1.

The court started its analysis by finding that the failure to update claim differs from Mensing because unlike the issue before the Supreme Court, here plaintiff is not asking the court to require generic manufacturers to provide additional warnings beyond those required of their brand counterpart.  Because the claim is not about a stronger warning, it does not violate the duty of sameness and therefore does not implicate impossibility preemption.  Id. at *3.  For that reason, plaintiff’s failure to warn claim is limited.  She essentially must concede that the brand warning is adequate and therefore, if provided by the generic manufacturer, would have prevented her injuries.  Id. at *4.

As noted above, implied preemption is another obstacle to the failure to update claim.  Afterall, the requirement to update the warning label is one imposed by the FDCA.  Under Buckman, a private citizen does not have the right to enforce a federal labeling requirement. But the court was willing to entertain a scenario where plaintiff could demonstrate that the failure to update is based on state law as well as a being a violation of the FDCA.  In that case, the claim could thread the preemption needle.  Id.

In sum, the court concluded that if a generic manufacturer failed to update its label to match the brand label, and the claim is limited to the “inadequacies of the non-updated label compared to the updated label,” and there is a state law basis for the claim – it is “not conclusively preempted.”  Id.  In this case, plaintiff did not sufficiently plead any of those elements to survive a motion a dismiss.  Plaintiff did not limit her liability allegations only to the failure to update.  In other words, all failure to warn claims except failure to update must go.  Plaintiff also failed to allege how her failure to update claim is based in state law.  Id.  Because the court was saying “maybe” as opposed to “never,” plaintiff is getting a chance to re-plead her failure to update claim.

Perhaps most importantly, however, the amendment is going to need to address causation.  It is on this ground that other courts in the Eighth Circuit, and elsewhere, have dismissed failure to update claims.  See id. at *6n.3.  Where the learned intermediary has independent knowledge of the risk, the failure to update cannot be the proximate cause of plaintiff’s injury.  As the court noted, “even though failure to update claims are not necessarily preempted, they may be difficult to prove on the merits, particularly in terms of causation between the label and injury.”  Id.   Here the generic and brand labeling already including warnings about peripheral neuropathy.  Based on our own digging, we believe the brand manufacturer added the strengthened warning in July 2013.  The FDA then made its safety announcement for all brand and generic drugs in the class to strengthen their warnings in August 2013.  Regardless of whether it took the generic manufacturer had not updated its label by November, the information was out there.  It was in the medical community.  Further, we know from experience that physicians tend to rely on the brand labeling, not the generic.  Often, the prescribing physician would never have seen the generic label – updated or not.  So, “maybe” may get you over the first preemption hurdle, but causation looms large on the horizon.

It’s not unusual for us to disagree with a decision from a state’s highest court.  Indeed, we did so vehemently not long ago with a decision by the Pennsylvania Supreme Court.  But even when we disagree, we rarely encounter decisions that make us cringe as much as Russell v. Johnson & Johnson, ___ S.W.3d ___, 2020 WL 6390218 (Ky. Oct. 29, 2020).  Consider it a post-Halloween haunted special.

Russell was about preemption in the context of an investigational medical device (“IDE”).  Early on, there had been something of a split about whether the statute’s preemption clause, 21 U.S.C. §360k(a), conferred significant preemptive protection on manufacturers of IDE devices, but federal appellate precedent universally recognized broad preemption.  In re Orthopedic Bone Screw Prod. Liab. Litig., 193 F.3d 781, 786 (3d Cir. 1999); Chambers v. Osteonics Corp., 109 F.3d 1243, 1247-48 (7th Cir. 1997); Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090, 1097 (6th Cir. 1997); Becker v. Optical Radiation Corp., 66 F.3d 18, 20 (2d Cir. 1995); Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333-34 (7th Cir. 1992).

After Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), pretty much every decision for over a decade recognized the same extensive preemption as was applicable to premarket approved (“PMA”) devices.  See Bush v. Goren, 2014 WL 4160245, at *7-8 (Mich. App. Aug. 21, 2014); Robinson v. Endovascular Technologies, Inc., 119 Cal. Rptr.3d 158, 164-165 (Cal. App. 2010); Parks v. Howmedica Osteonics Corp., 2016 WL 7220707, at *6 (M.D. Fla. March 11, 2016); Grant v. Corin Group PLC, 2016 WL 4447523, at *3 (S.D. Cal. Jan. 15, 2016); Day v. Howmedica Osteonics Corp., 2015 WL 13469348, at *4-5 (Mag. D. Col. Dec. 24, 2015); Caccia v. Biomet, Inc., 2013 WL 4502211, at *2 (N.D. Ind. Aug. 21, 2013); Burgos v. Satiety, Inc., 2013 WL 801729, at *7-8 (E.D.N.Y. March 5, 2013); Killen v. Stryker Spine, 2012 WL 4498865, at *1 (W.D. Pa. Sept. 28, 2012); Williams v. Allergan USA, Inc., 2009 WL 3294873, at *2-3 (D. Ariz. Oct. 14, 2009); Dorsey v. Allergan, Inc., 2009 WL 703290, at *5-7 (M.D. Tenn. March 11, 2009).

Another case that had done so, following this precedent, was Russell v. Johnson & Johnson, Inc., 2018 WL 5851101, at *4 (Ky. App. Nov. 9, 2018).  No longer.  That was the case that Russell, 2020 WL 6390218, overruled.

Our biggest problem with Russell is that it just doesn’t make much sense.  It describes §360k(a) as “limited,” in the following sense:

This limited preemption clause only applies to state “requirements,” meaning state standards and regulations—not state claims and causes of action.

2020 WL 6390218, at *3.  Russell looked for “guidance” to the definition of “preemption” in Black’s Law Dictionary.  Id. (“The principle (derived from the Supremacy Clause) that a federal law can supersede or supplant any inconsistent state law or regulation.”).  Russell therefore purports to hold that “when this preemption clause applies, it only preempts the state regulations that apply to the medical device.”  Id.

That’s malarkey.  Instead of consulting a general law dictionary, Russell would have done well to review the aforementioned Riegel decision, which dealt with and rejected the same argument – both generally and in the specific context of §360k(a):

Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments.  Absent other indication, reference to a State’s “requirements” includes its common-law duties. . . .   [C]ommon-law liability is “premised on the existence of a legal duty,” and a tort judgment therefore establishes that the defendant has violated a state-law obligation. . . .  In the present case, there is nothing to contradict this normal meaning.  To the contrary, in the context of this legislation excluding common-law duties from the scope of pre-emption would make little sense.

552 U.S. at 324-25 (emphasis added).  So, right off the bat, Russell fell for an argument decisively rejected twelve years ago in Riegel as making “little sense.”  Last time we checked, United States Supreme Court precedent was controlling on federal preemption questions.

But the logic of what Russell held should have been the end of the case:  no preemption, because − according to the Court’s decision to ignore the express holding in Riegel − there were no Kentucky statutory requirements at issue (other than a consumer fraud claim).  Id. at *3.  But no, Russell goes on to discuss “parallel” violation claims.  2020 WL 6390218, at *3, 5-6.  Why?  We’re not sure, but because Russell did, we will, too.

Russell meandered through several PMA preemption cases involving allegations of “parallel” claims, id. at *3, discussing in no discernible order Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015); Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010); Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc); and Hughes v. Boston Scientific Corp., 631 F.3d 762, 770 (5th Cir. 2011).  But Kentucky does not allow parallel claims for independent state-law reasons.  The same Kentucky Supreme Court has twice interpreted a Kentucky statute, Ky. Rev. Stat. §446.070, as forbidding common-law negligence per se claims based on violations of any and all federal statutes.  St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky. 2011); T & M Jewelry, Inc. v. Hicks, 189 S.W.3d 526, 530 (Ky. 2006).  See our discussion, here.

Rather than reconciling Kentucky law and parallel claims (or even recognizing the conflict), Russell then held, without discussing any IDE precedent at all (which, as we mentioned above is extensive), that it mattered that this product was still at the IDE stage and did not get full PMA from the FDA until a year after the plaintiff’s surgery:

Here, in contrast to the above cases, the [product] had not received FDA premarket approval and only had investigational device exemption status.  Although [it] ultimately received FDA premarket approval, it was . . . after [plaintiff’s] surgery.  Even if we assume medical devices with the investigational device exemption are able to qualify for federal preemption, Kentucky’s parallel tort claims are allowed; the federal preemption would only restrict the state standard that applies to the device.

Russell, 2020 WL 6390218, at *3.

We’re not at all sure what that word salad means, except for the bottom line, which is no preemption.  Is it that (contrary to Riegel) because there are no state “requirements”?  Is it because IDE preemption is less robust than PMA preemption?  Or is it dispositive that all the plaintiff’s claims are “parallel”?  Russell is totally unclear, except that preemption is a bad thing – United States Supreme Court precedent be damned:

Justice Ginsburg’s Riegel dissent provides insight. . . .  “FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection. . . .  Preemption of all such claims would result in the loss of a significant layer of consumer protection . . . .” 552 U.S. at 337-38 (emphasis added).  We agree and reiterate that Kentucky’s parallel tort claims are not preempted by federal law.

2020 WL 6390218, at *4 (emphasis original with Russell).  So the only thing that is really clear is that Russell “agrees” with a dissent in Riegel and thus refuses to apply the preemption that the eight other justices recognized in that case.

But even then we’re not sure – because Russell goes on to celebrate Kentucky’s “requirement of bare-bones, notice pleading.”  Id. at *5.  “[A] complaint couched in general and conclusory terms, complie[s] with” Kentucky pleading rules.  Id. at *4 (citation and quotation marks omitted).

Three cheers for nuisance value.

Thus, preemption can’t be decided in Kentucky state litigation without the defendant being subjected to costly and time-consuming discovery.  Down the road somewhere, maybe there will be preemption and maybe there will not:

Under Kentucky’s notice pleading standards, the motion for judgment on the pleadings should have been denied.  Even if investigational medical devices (such as the [product] at the time it was used with [plaintiff]) qualify for federal preemption, a party may pursue parallel state tort claims, and those claims are not preempted under federal law.  Here, under Kentucky’s notice pleading standard, [defendant] was properly put on notice of parallel claims.

2020 WL 6390218, at *6.

So we’re still scratching our heads at this one.  Even when some other appellate court decides to thumb its nose at controlling Supreme Court precedent, as happened here and here, we at least knew what the court had held and why.  In Russell we have something akin to Churchill’s “riddle” (Riegel and state “requirements”) “wrapped in a mystery” (parallel claims when Kentucky law rejects federal violations as negligence per se) “inside an enigma” (what happens when the pleadings finally get pierced).

As we write this, there is great uncertainty in the country.  The intersection of state and federal law is a focus, as is the possibility that one or more of the many recent challenges to how states count votes for the presidential election will end up in the Supreme Court.  The tension is palpable, in the knots in our stomachs, the bile rising in our throats, the thump of our carotids, and our obsessive doom-scrolling of “news” on our phones.  Some find a hot cup of tea soothing.  We cannot offer that to our readers, but we can try to read some tea leaves on a relatively recent Supreme Court argument.  Will it help?  The margin of error in any predictions we could make would be unacceptably wide.  (We know that none of this is actually funny, but awkward humor is a defense mechanism.)

Since the Supreme Court decided Bauman in 2014, we predicted, tracked, and recapped its impact on drug and device litigation, particularly the scourge known as litigation tourism.  The contemporaneous decision by the Court in Walden yielded less attention, but we have often viewed Bauman and Walden as a pair, the former defining the new standard for general personal jurisdiction and the latter defining the standard for specific personal jurisdiction.  As the lawyers for litigation tourists refused to accept what Bauman meant for their business model, one of their main arguments boiled down to “specific personal jurisdiction for the claims of another plaintiff or group of plaintiffs should make a defendant be subject to general personal jurisdiction for other plaintiffs’ claims.”  The Court swatted that down in BMS, citing both Bauman and Walden.  Along the way, and since BMS, we have posted on many permutations of the personal jurisdiction issues that affect our drug and device clients.  You may be shocked to hear, however, that there is litigation out there that does not involve drug or device manufacturers.  Like in Bauman, automobile manufacturers still get sued.  And, like in Bauman, the Supreme Court is considering another appeal related to personal jurisdiction, this time on specific jurisdiction.

What follows is our impressions of the October 7, 2020, oral argument in Ford Motor Co. v. Montana Eight Judicial District Court, which is actually a combined appeal of two state court decisions.  We have not dug into the briefs or the decisions below and will try to focus on the implications for drug and device cases.  We also will not recap all the back-and-forth or comment on how the Court’s composition has changed since October 7.  So, keeping things fairly general, there was a case brought against Ford (and, we assume, non-diverse defendants) in Minnesota state court related to an accident with a Ford vehicle originally sold in North Dakota in the mid-1990s and a case brought against Ford (and, we assume, non-diverse defendants) in Montana state court related to an accident with a Ford vehicle originally in Washington.  Ford is at home in Michigan, designs its vehicles there, and manufactures them in multiple states but not in Minnesota or Montana.  As is often the case in Supreme Court arguments, like in law school classes and exams, the facts were a jumping off point for many hypotheticals.  From what we know, Ford contested both general and specific personal jurisdictions in these cases and plaintiffs argued that specific jurisdiction applied largely because Ford conducted activities in each state and the accidents occurred in the states where the plaintiffs lived and chose to sue.

While the decision that comes down may help to clarify the standards for specific personal jurisdiction, the overall message from the oral argument is that personal jurisdiction is a confusing subject.  Back when general personal jurisdiction was easy to establish (except perhaps for foreign-based defendants), the concepts were relatively simple and it was not often necessary to analyze specific personal jurisdiction.  While we do think some of the confusion rests at the feet of the litigation tourism proponents, we were surprised that the concepts kept blurring the way they did.  It is true that the line of specific jurisdiction cases leading to Walden and expounding on Walden is less robust than on the general jurisdiction side, but the concepts seem separable.  Applying the concepts to the sort of forum shopping in which drug and device plaintiffs engage, the general jurisdiction inquiry relates to whether the defendant can be subject to suit in California or Missouri, for instance, no matter where the plaintiffs are from, the defendant is at home, or the operative actions of their claims took place.  For specific jurisdiction, the decision may be between two states whether plaintiff and the facts of the case have ties, probably with some overlay of the likelihood the case will end up in federal court.  With those predicates, a few things struck us from the argument.

First, maybe it owed to a remote format, but there was more interrupting than we recall from other arguments.  The Justices are expected to interrupt, of course, but it went both ways.

Second, Justice Thomas asked questions of both sides.  Having once gone a decade between posing questions in oral argument, maybe the remote format agrees with him.

Third, there was a surprising amount of discussion of due process almost as to whether there was some doubt that there are constitutional limits on the state exercise of personal jurisdiction.  We think of the concept as so ingrained that it is rarely necessary to go back to the starting point to analyze personal jurisdiction.  Like recounting the supremacy clause when arguing preemption, however, starting at the start can help an explanation sometimes.

Fourth, after a bunch of hypotheticals on how the defendant’s proposed proximate cause  standard for the old Helicopteros phrase that specific personal jurisdiction means the claims “arise out of and relate to” the defendant’s contacts in the forum state, which did not seem to advance the ball much, Justice Gorsuch highlighted the framework:

We’ve made a firm distinction between specific and general jurisdiction for many years.  We say specific jurisdiction has to “arise out of.”  Everybody seems to know what that means. Nobody knows what “relates to” means, the other part of the test.

Transcript at 28.  He then spelled out how the long-arm statutes fit into the process, which seemed to focus the inquiry, at least for a while.  There was still conflation of general and specific jurisdictions cases and principles after this.

Fifth, the dueling standards articulated by the parties were something like ships in the night and it was not clear the Court wanted to get aboard either one.  The proximate cause standard, with a sort of “but for” causation back-up, from Ford was intended to apply to all specific personal jurisdiction inquiries and, like proximate cause issues in trial courts, how the justices saw the application to every conceivable permutation did not necessarily match up.  The plaintiffs offered a narrow two-part test for product liability cases (and maybe cases against manufacturers):  “would the defendant be submitting to the coercive power of a state with little interest in the controversy” and would the plaintiff’s claims “really comes within” the defendant’s in-forum contacts.  Plaintiff posited that sales of the same type of product into the forum where plaintiff was injured would create personal jurisdiction over the defendant manufacturer, even if the plaintiff’s product was manufactured, designed, and sold elsewhere.  That sounds quite a bit like a hybrid between the general and specific standards articulated in prior cases and we read BMS as rejecting blurring the lines.

Sixth, the issue of how the defendant’s actions outside the forum state might give rise to specific personal jurisdiction was less developed.  Justice Kavanaugh, in particular, pushed on the issue of purposeful availment by cultivating a market that included the forum.  Interestingly, the plaintiffs conceded that non-targeted advertisement—like just having a site on the internet that offered products for sale wherever—would be insufficient to bestow jurisdiction everywhere.

Seventh, litigation tourism has a bad name and the plaintiffs tried to distance themselves from the BMS plaintiffs.  That included an express denial of “forum shopping.”  By emphasizing that they had sued where their accidents/injuries occurred, these plaintiffs clearly wanted to be seen as different.  We wonder whether whatever the Court does here will include some comments that can be used to oppose litigation tourism.

Last, what does this mean for drug and device manufacturers?  Clearly, the standard Ford articulated would be better than the standard that plaintiffs articulated.  It certainly makes sense that the forum contacts should be alleged to have (proximately) caused the injuries that the plaintiff claims; of course, drug and device plaintiffs tend to allege many cause of action that can involve behavior in multiple places.  Plaintiffs offered the criticism that “it would send injured plaintiffs on an irrelevant scavenger hunt to trace the route of the particular pill or toaster that caused injury, just to try to figure out where to sue.”  Transcript at 36.  It is unclear if a majority will think the burden of such pre-suit diligence is too great to impose.

A number of flaws in the plaintiffs’ proposal were highlighted by questioning from the justices and they would surely plat out in drug and device cases.  Focusing on sales of the product into the forum, for instance, could easily slide down a slope into sales of similar products or of components within the plaintiff’s product that were also included in other products.  Recent device litigation experience emphasizes how often complaints about a component can create a loud noise without any plausible connection to the claimed injury.  Speaking of device litigation, the plaintiffs touted that a number of state attorneys general had supported plaintiffs’ position, which made us think that the AGs want to expand the circumstances under which they can bring cases against out-of-state manufacturers for out-of-state conduct that alleged impacts in-state consumers.  We say “impacts” rather than “harms,” because some state consumer protection statutes, which bestow broad powers on AGs and the threat of treble damages, fines, etc., do not require demonstrable injuries to consumers.  Clearly, the plaintiffs’ proposal, which does not look at causation or injury, would be better for them.  Certainty on these issues for drug and device manufacturers, AGs, and private plaintiffs on the rules governing personal jurisdiction would be appreciated, but may not come as soon as anyone wants.  That dynamic sounds familiar.

 

The hip implant litigation, Rouviere v. DePuy, has already given us one of the classic opinions on the COVID-19 “new normal” in litigation practices.  See Rouviere v. DePuy Orthopaedics, Inc., ___ F. Supp.3d ___, 2020 WL 3967665 (S.D.N.Y. July 11, 2020) (blogged about here).  That decision was prompted largely by the plaintiff’s unreasonable litigation overreach (plaintiffs’ counsel appears to have more unfettered discretion than most, probably because he is apparently one of the plaintiffs).  Now it’s happened again, with the Rouviere litigation generating a second to-be-published decision on a relatively esoteric subject – this time, exclusion of turncoat experts.  Our immediate reaction to Rouviere v. DePuy Orthopaedics, Inc., ___ F. Supp.3d ___, 2020 WL 6265659 (S.D.N.Y. Oct. 25, 2020), is “you had to know you can’t do that.”

We’ve only blogged about the “turncoat expert” problem in prescription medical product liability litigation once before.  But it does recur.  Here’s what happened, but if you want to know that names of the offending parties, you’ll have to find them yourself.  While we’re happy to report on the other side’s misconduct, we don’t usually name names.

Before this particular litigation started, the defendant had retained “Expert X” to undertake “considerable consulting work in connection with other litigations for which his employers received substantial compensation.”  2020 WL 6265659, at *1.  In connection with this prior employment, the defendant took the reasonable precaution of having Expert X sign a confidentiality agreement before having access to the defendant’s proprietary information.  2020 WL 6265659, at *2.  Don’t ever think for a minute that these sorts of confidentiality agreements aren’t worth the bother.

Once Expert X showed up at the eleventh-and-a-half hour (after “several extensions” and the denial of yet another extension, id. at *1) as the plaintiffs’ designated expert, it filed a well-supported motion to disqualify:

[Defendant] filed the motion . . . seeking to disqualify . . . [Expert X] on the ground that [it] previously had retained him as a paid consultant to conduct confidential review, testing and analysis of other hip implant products in the defense of [its] Litigations where issues were raised, which are “in vital ways similar to those raised in the present litigation.”

6265659, at *2 (citation omitted).  Plaintiffs responded with a hail of excuses, chiefly:

  • Expert X “was not directly retained by” defendant.
  • Expert X “has not done any work for [defendant] since 2017.”
  • [T]he products at issue in this case are different from the products at issue in the case where [Expert X] performed work for” defendant.

Id.

Plaintiffs’ excuses were all for naught.  First, defendant’s expectations of confidentiality were “objectively reasonable.  Foremost was the existence of the original confidentiality agreement.  Id.  Beyond that, Expert X was also party to a confidentiality order in the prior litigations, and those litigations, while stayed, had not been “finally determined.”  Id.

Second, Expert X had been privy to quite a bit of confidential information.  “He received tens of thousands of pages of confidential . . . documents pertaining to the design and development of. . . hip devices, the materials used in those devices and the regulatory approval process.”  Id. at *3.  Expert X had also “met with . . . defense attorneys on numerous occasions in connection with the [earlier] Litigations” and knew about defendant’s “litigation and trial defense strategies.”  Id.

Third, “there is significant overlap between issues involved in the [earlier] Litigations and the issues involved in this case.”  Id.  Thus, it “would be unfair and would subvert the integrity of the judicial process to permit [Expert X] to switch sides as he is seeking to do here.”  Id.

Finally, defendant’s motion had been brought in a prompt fashion, minimizing “prejudice” to plaintiffs, who “only had worked with [Expert X] for a few days prior to the issuance of his report.

In the end, the only thing plaintiffs in Rouviere achieved by suborning defendant’s prior expert was to obtain yet another extension of their expert disclosure obligations (from September 21 until December 9, 2020).  The rest of us got the Rouviere opinion’s road map on how to deal with a turncoat expert.

Two weeks ago we wrote about a pelvic mesh case that crumbled on remand due to the plaintiff’s failure to depose the implanting physician. The importance of the implanting physician is self-evident. Because the plaintiff bears the burden of proving the elements of torts, including whether a different warning would have prompted the implanter to make a different decision, one would think that cases in which plaintiffs failed to depose the implanter would be vanishingly rare.

One would be wrong.

It did not take a lot of pawing through advance sheets to find another example. In Sweatman v. Coloplast Corp., 2020 U.S. Dist. LEXIS 78907 (D.S.C. May 5, 2020), the MDL judge had set a scheduling order, and the discovery cutoff (April 29, 2019), came and went without any deposition of the implanter. Further, remand (September 26, 2019) came and went without any deposition of the implanter. The transfer order stated that the “time to conduct discovery is complete in these cases.”

It is not as if the plaintiff did not know how to ask the MDL court for adjustments to the schedule. Shortly before remand, the plaintiff sought and received permission to substitute an expert witness. But the plaintiff never asked the MDL judge to tweak the discovery cutoff and permit a late deposition of the implanter.

Well after the September 2019 remand, on March 9, 2020, the plaintiff filed a motion for leave to reopen discovery for the limited purpose of deposing the implanting physician. We defense hacks are always worrying that, when it comes to discovery, courts give plaintiffs pretty much whatever they want. Thankfully, that is not true. There actually are standards.

What standard governs? The Sweatman court decided that “the proper standard to evaluate Plaintiffs’ motion is the good cause standard in Rule 16, FRCP, not the excusable neglect standard in Rule 6, FRCP.” That makes sense, as Rule 16 is the more specific rule. Under Fed. R. Civ. P. 16(b)(4), a scheduling order “may be modified only for good cause and with the judge’s consent.”

What is good cause? The primary consideration relates to the movant’s diligence. If the movant was less than diligent in complying with the court’s deadlines, then other factors, such as whether the movant acted in bad faith or whether the other party would be prejudiced, are NOT considered. That is a very important point, as absence of bad faith or prejudice are frequently seized upon by softies as reasons to afford scheduling relief. Nope. Lack of diligence shuts the door.

That door was slammed shut in the Sweatman case. The record showed lack of diligence in trying to depose the implanting doctor. According to the plaintiff, the problem was the doctor’s unavailability. But the plaintiff did not even try to contact the doctor until one month prior to the discovery cutoff. The scheduling order had been in place for seven months.

Significantly, Sweatman was not a case in which the plaintiff was unaware of the witness until after the passing of the discovery deadline. Nor was it a case in which the opposing party “failed to provide information that would have informed Plaintiffs as to the value of the testimony.” In short, the plaintiff lacked any excuse. Rather, this was an example of a plaintiff waiting too long, “playing with fire,” and now seeking a “second bite of the apple.”

Accordingly, the Sweatman court concluded that “merely calling the witness on several occasions one month prior to the expiration of the discovery deadline and then waiting another seven months to raise the issue for the first time” does not constitute diligence and does not constitute good cause.

A chief malignancy of the MDL process is the mass warehousing of cases, with little to no work done on most of them. Some plaintiff lawyers (the lazy ones – who are a minority but who also manage to ruin the whole process) count on settling their cases without an ounce of effort. But not all cases settle before remand. Sweatman is a much needed wake up call.

This blogger’s work from home experience has included a lot of time with two teenagers.  Granted, two relatively smart, funny, and generally OK to be around teenagers.  But teenagers, nonetheless.  So, I’ve been witness to some true common senseless moments.  Like twenty minutes of trying to start the lawnmower before checking if it had gas.  Like thinking a bag of raw potatoes belonged in the freezer, where they were found weeks later.  Like anything to do with a knife larger than a paring knife (we are truly lucky all 20 fingers are still attached).  And that’s beside the typical dirty dish in the sink rather than the dishwasher; dirty laundry next to but not in the hamper; and the miraculously always empty toilet paper roll.  Clearly common sense is experience driven and we are doing our best to turn these into teachable moments.  The teens did cook a complete dinner from scratch with only one minor nick, so we are making progress.  However, while common sense is a necessity in life, it’s often not enough in a drug/device products case.

That’s what plaintiff learned in Emmons v. Teleflex Incorporated, 2020 WL 6286304 (Ariz. Ct. App. Oct. 27, 2020).  Plaintiff received an epidural to assist with pain during childbirth.  When the nurse attempted to remove the epidural, she met with resistance and a piece of the device broke off and remained implanted.  Id. at *1.  Plaintiff’s lawsuit against the manufacturer of the device alleged only a manufacturing defect.  Plaintiff offered no expert evidence in support of her claim.  In response to defendant’s motion for summary judgment, plaintiff stated that was relying on the doctrine of res ipsa loquitur – the thing speaks for itself.  It means it is so obvious the accident was caused by negligence that the plaintiff does not need direct proof of negligence.

In a res ipsa case, the plaintiff typically has to prove (1) the injury is of a kind that ordinarily does not occur in the absence of negligence, (2) the injury is caused by an agency or instrumentality in the control of the defendant, and (3) the plaintiff is not in a position to show the particular circumstances that caused the injury.   Id. at *3.  But that is in a negligence case.  Plaintiff here only brought a strict liability manufacturing defect claim.  There the question is whether the product was in a defective condition and unreasonably dangerous.  So, the res ipsa questions are (1) whether the harm was the kind ordinarily caused by a product defect and (2) the harm, in the particular case, was not the result of other causes.  Id.

Here plaintiff argued that an epidural catheter doesn’t break absent a defect and that the nurse who removed it followed the instructions for removal; therefore, the defect caused plaintiff’s injury.  That’s a common sense argument.  But in a res ipsa product defect case, it’s not enough.

In some product liability cases, common knowledge may enable a layperson to conclude reasonably that the type of injury suffered by the plaintiff would ordinarily occur due to a defective product. However, this case involves removing a medical device, and an accident of this nature cannot solely be analyzed by common sense.

Id.  First, the Instructions for Use that accompany that epidural provide that the product can break if excessive force is used and explicitly warn against tugging or pulling on the device, offering an alternative removal technique if resistance is encountered.  Id. at *1.  So, without evidence to the contrary, plaintiff cannot support her contention that a break equals a defect.  Second, the plaintiff’s medical records indicate that the nurse encountered resistance in removal.  Plaintiff offers nothing in response to show that the nurse followed the manufacturer’s instructions for removal in that circumstance.  Id. at *4.

Finally, plaintiff’s lawsuit was not brought solely against the epidural manufacturer. She also sued the hospital for negligence by its employee during the removal.  Id. at *1.  While alternative pleading is certainly allowed, even encouraged, it does have its pitfalls.  Namely, “that [p]arties are bound by their pleadings and evidence may not be introduced to contradict or disprove what has been admitted or asserted as fact in their pleadings, and a party may not introduce evidence in contradiction of express allegations of [her] complaint.”  Id.  Meaning, you can’t place blame on the nurse on one hand and argue the injury was solely caused by the product defect on the other.

So plaintiff failed both parts of the res ipsa test – there was an explanation for the break that wasn’t a product defect (resistance) and plaintiff herself argued her injury was the result of a cause other than the break (the nurse).  Can’t have it both ways.   That’s just common sense.

Back in 2018, upon reading the bad general jurisdiction by consent decision, Webb-Benjamin, LLC v. International Rug Group, LLC, 192 A.3d 1133 (Pa. Super. 2018), and the worse Hammons v. Ethicon, Inc., 190 A.3d 1248 (Pa. Super. 2018), “specific” (we use that term advisedly) jurisdiction case a few months later, we commented that it appeared that the Commonwealth of Pennsylvania was going off the personal jurisdiction “deep end.”

Following up on that metaphor, the Pennsylvania Supreme Court’s recent affirmance in Hammons v. Ethicon, Inc., ___ A.3d ___, 2020 WL 6155256 (Pa. Oct. 21, 2020), was the jurisprudential equivalent of yelling “Cannonball!” while diving into the aforementioned jurisdictional deep end.  Hammons not only concluded that the Supreme Court was all wet in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”) (opting instead for Justice Sotomayor’s lone dissent), but also added yet another burden to Pennsylvania’s struggling manufacturing sector, since the only way for a defendant to avoid the burgeoning Pennsylvania mass tort Mecca is to avoid doing business with anyone in the Commonwealth.  After listening to the oral argument on PCNTV, we were unhappy, but not particularly surprised, by this outcome.

That said, Hammons in the Pennsylvania Supreme Court was still marginally better than the “appallingly bad” intermediate appellate decision that it mostly affirmed.

The plaintiff in Hammons was a Pelvic Mesh litigation tourist from Indiana, with her surgery and claimed injuries occurring in Indiana.  She has no contacts at all with Pennsylvania other than eventually hiring a Philadelphia lawyer.  2020 WL 6155256, at *1.  Thus, she lacks any of the in-state “adequate links” recognized by the Supreme Court in BMS:

The State Supreme Court found that specific jurisdiction was present without identifying any adequate link between the State and the nonresidents’ claims.  As noted, the nonresidents were not prescribed [the product] in California, did not purchase [the product] in California, did not ingest [the product] in California, and were not injured by [the product] in California. . . .

137 S. Ct. at 1781.  Absent such forum-based facts, “a corporation’s continuous activity of some sorts within a state . . . is not enough to support the demand that the corporation be amenable to suits unrelated to that activity.”  Id. (citation and quotation marks omitted).  “What is needed . . . is a connection between the forum and the specific claims at issue.”  Id.  What was not enough to establish specific personal jurisdiction in BMS?  “The bare fact that [defendant] contracted with a [forum] distributor is not enough to establish personal jurisdiction in the State.”  137 S. Ct. at 1783.

Hammons’s analysis started out with what can only be described as poking the BMS decision in the eye with a sharp stick.  While that decision was 8-1, Hammons chose to quote and follow, instead, the lone dissent:

As Justice Sotomayor cited in her dissenting opinion in BMS, a preeminent treatise on federal practice and procedure observed that courts have synthesized the specific personal jurisdiction caselaw into a more manageable three-part test:

(1) Did the plaintiff’s cause of action arise out of or relate to the out-of-state defendant’s forum-related contacts?

(2) Did the defendant purposely direct its activities, particularly as they relate to the plaintiff’s cause of action, toward the forum state or did the defendant purposely avail itself of the privilege of conducting activities therein?

(3) [W]ould the exercise of personal jurisdiction over the nonresident defendant in the forum state satisfy the requirement that it be reasonable and fair?

2020 WL 6155256, at *15 (quoting BMS, 137 S.Ct. at 1785 (Sotomayor, J. dissenting) (internal citations omitted)).  We’ve been practicing law a long time, and to see an appellate court begin a legal discussion relying on a lone dissent to an otherwise controlling decision is a new one on us – and also a harbinger of things to come.  Hammons then reviewed the majority decision in BMS, focusing on other facts that the Supreme Court had observed were absent.  “Moreover, the company did not develop, manufacture, label, package, or work on the regulatory approval of the product in California, nor did it devise its national marketing strategy in the state.”  2020 WL 6155256, at *16 (BMS citation and quotation omitted).  Hammons then mentioned the BMS holdings rejecting a “sliding scale” as a “loose and spurious form of general jurisdiction,” denying “the relevance of the overlap between the claims of the [forum] and non-[forum] plaintiffs,” and requiring “a connection between the forum and the specific claims at issue.”  Id. (BMS citations and quotations again omitted).

Then it was back to what Hammons described as the “lone but forceful dissent” in BMS, id. at *17, which:

asserted that the [majority] decision, while claiming to apply established precedent, actually resulted in a dramatic shift.  [The dissent] feared that the holding would make it impossible to bring a nationwide mass action in state court against defendants who are ‘at home’ in different States.  [The dissent] argued that there was nothing unfair about subjecting a massive corporation to suit in a State for a nationwide course of conduct that injures both forum residents and nonresidents alike.  [The dissent] instead opined that permitting the nonresidents to bring suit in California alongside the residents facilitates the efficient adjudication of the residents’ claims and allows it to regulate more effectively the conduct of both nonresident corporations.

Id. (BMS citations and quotations again omitted).

Thus Hammons expressly chose to disregard the Supreme Court’s holding in BMS that “[w]hat is needed − and what is missing here − is a connection between the forum and the specific claims at issue.”  137 S. Ct. at 1781.

While language focusing on the term “specific claims” can be excerpted from the BMS decision to support [the defendant’s] reading, we are hesitant to conclude that the Court dramatically narrowed the construct of specific personal jurisdiction to require a claim-by-claim analysis sub silentio.

Hammons, 2020 WL 6155256, at *17.  Hammons professed to find support for this view in  Walden v. Fiore, 571 U.S. 277 (2014), which it described as “look[ing] not to the elements of each individual claim for purpose of specific personal jurisdiction but rather “focuse[d] on the relationship among the defendant, the forum, and the litigation.”  2020 WL 6155256, at *17 (quoting Walden, 571 U.S. at 284).  That’s not at all what Walden was about.  The main holding in Walden was that only a defendant’s “suit-related conduct,” not its relationship with some in-state third party, can support specific personal jurisdiction:

For a State to exercise jurisdiction consistent with due process, the defendant’s suit-related conduct must create a substantial connection with the forum State. . . .  First, the relationship must arise out of contacts that the “defendant himself ” creates with the forum State.  Second, our “minimum contacts” analysis looks to the defendant’s contacts with the forum State itself, not the defendant’s contacts with persons who reside there.

Walden, 571 U.S. 284-85 (citations and quotation marks omitted) (emphasis added).  The snippet Hammons quoted from Walden was prefatory, a quote dating back to Shaffer v. Heitner, 433 U.S. 186, 204 (1977), and was not part of the rationale supporting the actual holding in Walden.

Instead of the result in BMS, or its emphatic rejection of specific jurisdictional arguments that sought to create “loose and spurious form[s] of general jurisdiction,” Hammons treated BMS as no big deal – simply “rel[ying] upon [the Supreme Court’s] prior phrasings of specific personal jurisdiction,” “terminology invokes not merely connections to ‘specific claims’ but broader links between the defendant and the ‘suit’ or the ‘controversy.’”  2020 WL 6155256, at *17.   Relying entirely on this “broader terminology,” expressed in “concepts of ‘suit,’ ‘controversy,’ and ‘litigation’ as opposed to individual ‘claims,’” Hammons “agree[d] that the focus of the jurisdictional question should be the actions of the defendant in relation to the forum” rather than what the plaintiff actually sued about.  Id.  “[A]bsent further clarification from the High Court, we decline to restrict jurisdiction by focusing narrowly on the elements of plaintiff’s specific legal claims, which could unnecessarily restrict access to justice for plaintiffs.”  Id. at *18 (footnote omitted).

And with that sleight of hand – ignoring everything that distinguished BMS from prior Supreme Court jurisdictional decisions − Hammons proceeded to create precisely the sort of “loose and spurious form of general jurisdiction” that the Supreme Court had condemned in BMS.  Instead of considering anything having to do with the plaintiff herself, the Hammons decision looked solely to the defendant’s overall contacts with Pennsylvania – focusing on contacts that any plaintiff from anywhere in the country could equally well assert.  Likewise, Hammons’s result flew in the face of what Walden required – analysis of “the defendant’s contacts with the forum State itself, not the defendant’s contacts with persons who reside there.”  571 U.S. at 285.

All of these contacts concerned the defendant having contracted to have the mesh component of the device knitted together by an independent contractor located in Pennsylvania.  Id. at *19-20.  None of the contractor’s actions had been a point of contention at trial – which did not even pursue a manufacturing defect claim – but rather, this contractor had been held immune from suit under the federal Biomaterials Access Assurance Act.  Hammons, 2020 WL 6155256, at *4.  Thus, this Pennsylvania entity had no more ties to the matter at suit than the aforementioned in-state distributor in BMS whose actions the Supreme Court had held to be insufficient in that case.  137 S. Ct. at 1783.  Unwilling to “restrict” the “access” of any plaintiff anywhere in America to a Pennsylvania courthouse, Hammons held that a defendant’s supervision of its non-liable independent contractor, alone, was sufficient to establish specific personal jurisdiction:

[Defendant] was substantially and directly involved in the production of the mesh in Pennsylvania, where the mesh was what [plaintiff] asserted caused her injuries and which served as the critical factual component of each of [plaintiff’s] claims. . . .  [Defendant] was involved in the production of the mesh by [the contractor] in Pennsylvania, and [plaintiff] claimed her injuries resulted from that mesh.  Thus, there is a direct connection between [plaintiff’s] cause of action and [defendant’s] actions in Pennsylvania.

2020 WL 6155256, at *20 (footnote omitted).

We note that the relationship found sufficient in Hammons was only to the “cause of action,” interpreted broadly as anything conceivably having to do with the product in general – not even the majority in Hammons could plausibly argue that there was any connection to the plaintiff’s “specific claims,” as BMS had required.  It would not be “unfair,” Hammons declared, “to subject [defendant] to jurisdiction here given that it is already litigating the related claims brought by Pennsylvania Plaintiffs.”  Id.  But, once again, coincident claims by in-state residents is precisely what the United States Supreme Court had held was insufficient in BMS to support specific jurisdiction.

Overall, Hammons, with its heavy reliance on a lone dissent and its explicit disregard for the Supreme Court’s “specific claims” language in BMS can only be viewed as a calculated challenge to that decision’s ultimate holding that aggregation of mass torts in far-flung venues constitutes a jurisdictional overreach that violates Due Process.  137 S. Ct. at 1783-84 (aggregation only permissible where “general jurisdiction” exists).  Where have we seen this kind of thing before?  We’re not old enough to recall civil rights cases from the 1960s, but Hammons reminds us of the First Circuit’s flat refusal to follow Mensing in the Bartlett litigation, which we described here.  We fully expect the defendants in Hammons (like the defendant in Bartlett) to “Take It Up” to the Supreme Court, where an 8-1 majority decided BMS only three years ago.  We can only hope that the High Court doesn’t suffer from personal jurisdiction fatigue.

Moreover, as to “fairness” – what about fairness to the residents of Philadelphia (which include some of us bloggers), who are forced to sit on juries, have their tax dollars expended, and have their access to their own courts delayed, by out-of-state residents who are perfectly able to seek relief in their home-state’s courts?  Apparently, we don’t count as much as litigation tourists with dollar signs in their eyes.  So, when COVID-19 restrictions on civil jury trials are eventually lifted, Philadelphia residents will have to compete in a backlogged system with plaintiffs from other states to have their disputes adjudicated.  What about our “access to justice”?

End of personal rant.

In our own spirit of fairness, however, we also point out that, as adverse as Hammons is, it is still not as bad as the decision it affirmed, which we criticized here.  The Pennsylvania Supreme Court at least got the burden of proof issue correct – holding, contrary to the unprecedented result below, that defendants were not required to disprove assertions of jurisdiction against them:

Pennsylvania courts have repeatedly opined in addressing a defendant’s challenge to personal jurisdiction that the burden is first on the defendant, as the moving party, to object to jurisdiction; once raised by a defendant, the burden of establishing personal jurisdiction under Pennsylvania’s long arm statute is placed on the plaintiff asserting jurisdiction.  The defendant can respond by demonstrating that the imposition of jurisdiction would be unfair.  We recognize that this practice is consistent with federal jurisprudence.

2020 WL 6155256, at *19 (citations omitted).  On this one point, anyway, the Hammons court agreed with the caselaw we cited in our posts.

Finally, while we’re on the general subject, the other jurisdictional “deep end” issue we discussed in our prior posts, general jurisdiction by consent, is now also headed for the Pennsylvania Supreme Court.  We previously discussed Mallory v. Norfolk Southern Railway Co., 2018 WL 3025283 (Pa. C.P Philadelphia Co. May 30, 2018), which declared the Pennsylvania Long Arm statute unconstitutional because it allowed such jurisdiction contrary to Daimler AG v. Bauman, 571 U.S. 117 (2014).  Mallory has been on appeal, and was recently (10/30/2020) transferred to the Pennsylvania Supreme Court, pursuant to 42 Pa. C.S. §5103(a), since that court has exclusive appellate jurisdiction in such situations.

For our loyal readers mourning a missed, or modified, Halloween, Reed Smith has a treat to offer: a series of complimentary, life sciences-focused CLE webinars running from November 9 to 13 as a virtual “Life Sciences CLE Week.” (See below for information on jurisdictions in which credit is offered.) Reed Smith typically offers this program annually as an intimate, in-person event for clients, but is pleased to offer this COVID-revised version to a broader audience.

Two of your bloggers, Bexis and Steve McConnell, will be giving a presentation that Wednesday on Albrecht and implied preemption – Is there any clear evidence where we go from here?”

Rachel Weil will also be joined by several of our product liability colleagues for a Monday presentation on, “The ABCs of an MDL: Lessons learned through the lens of a case,” which will include an interesting discussion on strategies that anticipate remand, what happens after remand, and best practices to position your clients for success at trial.

The line-up also includes:

  • “Best practices and war stories from remote litigation and arbitration,” presented by Reed Smith colleagues drawing on their experience conducting a remote jury trial, a remote arbitration, and a remote mediation to offer “from the trenches” perspectives and best practices.
  • “Current trends in False Claims Act and antitrust enforcement,” which will include COVID-related issues.
  • “Pharma’s evolving relationship with telehealth,” which will discuss how pharma is increasingly focused on telehealth providers and the key regulatory and enforcement issues to consider in such relationships.
  • “The benefits of arbitration for life sciences and health care industry disputes,” which will discuss the benefits that arbitration offers for both domestic and cross-border life sciences and health care industry disputes, including arbitrator expertise, confidentiality, procedural flexibility, more targeted documentary disclosure, global enforceability of awards, single venue proceedings, and a less combative environment that permits parties to continue doing business together.

Each webinar in this series is presumptively approved for CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed.

To register, or for more detailed information on the credit offered for each session, please visit the registration page.