A little more than six months ago, we reviewed then-pending federal right-to-try legislation.  Since then it’s become a shiny object, capable of distracting those governing the country from more important matters.  One version, H.R. 5247,  just passed the House of Representatives.  Another version, S. 204, which we reviewed in our prior post, passed the Senate last August.

Setting aside from our general view that right-to-try legislation isn’t enough (if any) of an improvement over the FDA’s already operating compassionate use program to be worth the legislative bother, is this version any better than the last?

The answer is yes.

First of all, it’s more limited.  The prior version applied to any “life threatening condition,” without requiring that the threat be imminent.  The House-passed bill is not as overbroad.  This new version applies only to conditions with “reasonable likelihood that death will occur within a matter of months.”  That’s much more in line with how “right-to-try” has been pitched to the public – as a matter of last resort.

The other major gripe we had with the terms of the prior Senate bill – preemption of tort litigation – has also been addressed.  Last time, any immunity for manufacturers participating in the program was predicated on “compliance,” which, as anyone paying attention knows, is easily pleaded around and thus hardly worth the paper it was printed on.  The relevant language now eliminates that caveat:

No manufacturer or sponsor (or their agent or representative) of an investigational drug shall be liable for any alleged act or omission related to the provision of such drug to a single patient or small group of patients for treatment use in accordance with subsection (b) or (c) of section 561 or the provision of an eligible investigational drug to an eligible patient in accordance with this section, including, with respect to the provision of an investigational drug under section 561 or an eligible investigational drug under this section, the reporting of safety information, from clinical trials or any other source. . . .

(Emphasis added).  This provision does several things, all of which improve upon the prior bill.  First, it eliminates the compliance prerequisite to preemption.  It’s now a flat “[n]o manufacturer . . . shall be liable.”   Second, as the highlighted language, above, makes clear, the same immunity from tort will apply both to right-to-try and to participation in the FDA’s compassionate use program (FDCA §561(b-c), a/k/a 21 U.S.C. §360bbb(b-c)).  That’s only fair, since there is no reason in the world for a manufacturer to be worse off, from a preemption perspective, for participating in an FDA-supervised program.  Third, the statute makes clear that there can be no liability for purported failure to report adverse events.

The absolute prohibition on liability for non-participation, which we liked before, is if anything stronger in H.R. 5247.  We certainly don’t want to see any resuscitation of the Abigail Alliance nuttiness.

The rest of the House-passed bill also looks pretty much the same, except for a provision governing adverse event reporting both for right-to-try and for compassionate use.  As before (although the language might be somewhat different), H.R. 5247 includes an informed consent provision, general reporting requirements, incorporation of the regulatory provisions limiting charges for investigational drugs, a general prohibition (with a quite limited exception) on the FDA using adverse events to interfere with the approval process of eligible investigational drugs, and limitations on liability for participating health care providers.  As to this last point, there are several exceptions for aggravated conduct, one of which is a state-law “intentional tort.”  Given that a few states (Pennsylvania, we know) continue to treat informed consent actions as battery claims, that language may result in broader participant liability (and thus more reluctance to participate) than the bill’s drafters intend.

We remain skeptical about whether right-to-try statutes actually help anyone, as opposed to being political grandstanding.  That said, from the perspective of attorneys representing pharmaceutical companies, this bill is about as good as it could be, and – to the extent that it extends preemption to the compassionate use program – it even marginally improves current law.

We have written a lot about personal jurisdiction and class actions, and we have particularly questioned how, after BMS, anyone could proceed with a nationwide class action applying state law in a forum where there is no general personal jurisdiction over the defendant.  We are not the only ones posing this question, but as has so often been the case, Bexis has led the way with two extraordinarily useful posts surveying the cases.  You can review these must-read posts here and here.  You can also get Bexis’ Washington Legal Foundation white paper on the topic here.

The issue is whether a court can exercise specific personal jurisdiction over claims asserted on behalf of out-of-state class members.  Take for example a putative nationwide class action in which a California class representative sues a New York defendant in California in connection with goods purchased in California.  Can this class representative purport to represent absent class members who reside and purchased goods outside California?  We think the answer clearly is no, since those non-Californians cannot establish specific personal jurisdiction over the New York defendant in California.

Most courts agree with us, and judging from our prior posts, the issue is often decided on a motion to dismiss. But is a motion to dismiss the only way to invoke BMS and its limitations on specific personal jurisdiction in a nationwide class action?  If you move fast, you can probably use BMS to oppose class certification, which is what happened last week in another Illinois case, Practice Management Support Services, Inc. v. Cirque du Soleil, Inc., No. 14 C 2032, 2018 WL 1255021 (N.D. Ill. Mar. 12, 2018).  In Practice Management, an Illinois company filed a nationwide class action in Illinois under the Telephone Consumer Protection Act (“TCPA”) against a Canadian company after received a fax advertising a circus performance in Illinois.

The case had been proceeding in federal court for several years, apparently including briefing on the plaintiffs’ motion for class certification, when the Supreme Court decided BMS.  The defendants therefore filed a supplemental brief asserting that BMS “prevents this Court from asserting personal jurisdiction over the Defendants with respect to the claims of putative class members located outside of Illinois” and that the case was therefore relevant to class certification. Id. at *15.

The district court agreed with the defendants, and its marquee holding is that BMS’s limitations on specific personal jurisdiction apply to class actions in federal court.  After citing other district judges who had so found, the district court made this broad ruling:

This Court agrees with these courts. Indeed, it [is] not clear how [Plaintiff] can distinguish the Supreme Court’s basic holding in Bristol-Myers simply because this is a class action.  The Supreme Court has emphasized that “Rule 23’s [class action] requirements must be interpreted in keeping with Article III constraints, and with the Rules Enabling Act, which instructs that the [federal court] rules of procedure ‘shall not abridge, enlarge, or modify any substantive right.’” Amchem Prods. v. Windsor, 521 U.S. 591, 592 (1997) . . .  The Supreme Court held in Bristol-Myers that the Fourteenth Amendment’s due process clause precludes nonresident plaintiffs injured outside the forum from aggregating their claims with an in-forum resident. Bristol-Myers, 137 S. Ct. at 1781.  Under the Rules Enabling Act, a defendant’s due process interest should be the same in the class context.

Id. at *16. This reasoning is essentially bulletproof, and the district court’s holding is bookended by another significant ruling—that the defendants did not waive their personal jurisdiction challenge. Id. at *17.  Remember, the defendants litigated this case in the Illinois federal court for years, and they did not raise personal jurisdiction in their answers.  But here, BMS was a game changer.  The district ruled that a personal jurisdiction challenge would have been futile before BMS and that the defendants “timely raise[d] their personal jurisdiction defense in a motion that timely followed the Supreme Court’s decision.” Id. Because other defendants sued before BMS are surely in a similar position, the district court’s no-waiver holding should not be overlooked.

If you stopped reading here, you would have the gist of Practice Management.  But the plaintiffs made other arguments, too.  They argued that the district court could exercise jurisdiction over a nationwide class under Phillips Petroleum Co. v. Shutts, 472 U.S. 797 (1985), where the Supreme Court held that courts could exercise personal jurisdiction over absent class member’s claims without violating the class members’ due process rights. Id. at *16.  But that is apples and oranges.  The issue in Practice Management was the defendants’ due process rights.  An absent class member has the right to notice and opt out before being bound to a class judgment.  A defendant whose objection to jurisdiction is overruled is being compelled to answer the out-of-staters’ claims and has no choice.  That’s a big due process difference.

The plaintiffs also argued that BMS left open the question of whether the Fifth Amendment’s due process clause imposed the same restrictions on the exercise of personal jurisdiction by a federal court.  We are aware of a handful of district judges who have bought this argument, and suffice it to say that we do not agree that due process under the Fifth Amendment is fundamentally different from due process under the Fourteenth Amendment when it comes to personal jurisdiction.  In Practice Management, it did not matter:  The TCPA does not authorize nationwide service of process and looks to state law for limitations on personal jurisdiction in any event. Id. at *16.  Thus, BMS applies.

The district court therefore followed BMS and ruled that it did not have jurisdiction over nonresidents’ claims:  “Because these nonresidents’ claims do not relate to defendants’ contacts with Illinois, exercising specific personal jurisdiction over defendants with respect to them would violate defendants’ due process rights.” Id. at *18.

The practical impact of this ruling is that this class action is now limited to Illinois only. In the portion of the order that we have not discussed, the district court granted class certification.  But instead of a class of fax recipients from anywhere, the district court redefined the class to include Illinois residents who received faxes in Illinois.  Maybe that is small consolation, but it is consolation nonetheless, and by raising their challenge when they did, the defendants created a published order on personal jurisdiction that will help us all.  We will be sure to thank them when the circus is over.

All of us – defense lawyers, plaintiff lawyers, and judges – tend to assume that the federal Daubert standard for admissibility of expert testimony is more rigorous than competing standards, particularly the Frye standard, which lingers in a minority of jurisdictions (and not even where it originated).  In simple terms, Frye merely asks whether the expert opinions find general acceptance in the relevant expert community, whereas Daubert digs into the reliability of the particular opinions.  Put another way, Frye makes judges count experts, whereas Daubert makes them become experts.  Maybe that is why there are so many judges that hate Daubert and apply it in name only. When application of the Daubert standard results in exclusion of an expert opinion, it is usually the reliability component, not, say, qualifications, that does the excluding.  Daubert’s reliability component, in turn, contains several components.  Some are highly technical, such as rate of error.  Others are a little easier to understand, such as whether the expert opinions are litigation-driven, whether peer review literature supports the opinions, and – ta da! – whether the opinions find general acceptance in the field.  That is, Daubert incorporates Frye to a certain extent.  But whereas general acceptance is the whole ballgame in Frye, general acceptance is only one among several factors, and is not by itself dispositive.  Consequently, one can dream up a scenario where an expert opinion might get knocked out by the Frye standard but would make it to the jury under Daubert.  Think of an expert opinion that lacks general acceptance but otherwise can lay claim to other indicia of reliability.  You might not find it terribly easy to conjure up such an expert opinion.  After all, how has a reliable opinion not achieved general acceptance?  Is it just too new?  Would you be surprised to learn that the Daubert standard was initially created by courts to liberalize Frye? Be that as it may, the point drilled home by today’s case, In re 3M Bair Hugger Litig., 2018 WL 894021 (Minn. Dist. Ct. Jan. 8, 2018), is that, every once in a while, the old Frye standard really cooks.


It appears from the introduction to the state court’s opinion that a hearing on expert admissibility was held jointly before the state and federal courts in the Bair Hugger litigation.  Such state-federal coordination is a welcome dose of efficiency in aggregated litigation.  The plaintiffs and defendants moved to exclude each other’s expert opinions, and the defendants moved for summary judgment with respect to general causation.  The medical device in question was the Bair Hugger, which is used to maintain a patient’s normal body temperature during surgery.  The court pointedly tells us that “[m]ore than thirty years ago, it became generally accepted within the relevant scientific community that maintaining a patient’s normal body temperature (“normothermia”) during surgery led to decreased infection rates, a shorter period of post-operative recovery, and improved healing. This theory remains generally accepted, and various manufacturers compete to market their warming devices.”  Nice job foreshadowing the “general acceptance” issue.  The issue in the litigation was whether the Bair Hugger’s forced-air system of temperature regulation increased the chances of infection.   That was the opinion proffered by the plaintiffs’ three medical experts, and the issue was whether such opinions were generally accepted.  And now we will do a little foreshadowing ourselves:  they weren’t.  Hug the Bair Hugger litigation goodbye.


But first you will want a bit of background.  That background is a bit tawdry, and it is hard to think such background did not make it a little bit easier for the court to drop both the plaintiffs’ expert opinions and complaints into the trash bin.  The Bair Hugger had been invented by a fellow named Augustine.  The Bair Hugger became the leading warming device in the world.  Then came bad news.  That inventor was notified by the United States Department of Justice that he was under investigation for Medicare fraud. Augustine resigned from the company.  He later pled guilty, was fined $2 million, and was prohibited from participating in federal health-care programs for five years.  The Bair Hugger device continued to be successful. 


Augustine later invented a competing normothermia device, this time employing electric conduction rather than forced air.  He called this new device “the HotDog.” As if the reference to a delicious meat snack was not enough to win over customers, Augustine then did his best to attack his old device.  In 2008, he began to impugn the safety of the Bair Hugger overseas. He issued a press release criticizing forced-air warming systems such as the Bair Hugger. Augustine claimed that such devices increased the risk of surgical infections. The United Kingdom National Institute for Health and Clinical Excellence rejected this claim, concluding that forced-air warming devices were not associated with an increased risk of infection.


Then things got even nastier.  Augustine hired a law firm to promote the use of HotDog patient warming, and he agreed to work with the law firm as a “non-testifying expert.” That law firm eventually began to represent individuals in lawsuits to be brought against the Bair Hugger.  But meanwhile, the efforts to besmirch the Bair Hugger’s safety were as unsuccessful in the United States as in the United Kingdom.  The FDA investigated the allegation that the Bair Hugger increased the risk of bacterial contamination. It did not agree with the allegation.  And now we get a wonderful little observation from the Minnesota court that captures so much about what is wrong with mass tort drug/device litigation:  “The FDA exercises a more stringent approach to product safety than state and federal courts…. The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standards used to assess tort liability.”  Just so.  And yet we spend the major portion of the day defending claims against drugs and devices that the FDA chooses to leave on the market.  We think of the Jeremiad: “And still we are not saved.”  (We have a post about the FDA enforcement standards being less than the common law tort “more likely than not” standard.  Where do we have it?  Here.) 


Back to our story.  The bad turns ugly.  In 2012, the inventor-turned-competitor-turned-adverse-expert tried “to coerce” a defendant into purchasing his HotDog system by warning that the defendant “would suffer a significant loss of market share and ‘a lot of negative marketing rhetoric’” about the Bair Hugger causing infection if the sale did not occur.  It’s as if the inventor was trying to make the defendant an offer it could not refuse.  But guess what?  The defendant refused. 


Then Augustine began to market the HotDog as reducing the rate of surgical infections when compared to forced-air systems. In response, the FDA sent a warning letter to Augustine in 2012, stating that his claim was without clinical support and made without FDA approval. Meanwhile, the Hotdog in-house counsel proposed to prepare a “detailed guide” to sue the Bair Hugger. Even so, Hotdog again proposed a marriage with the Bair Hugger.  Again, the proposal was rejected.  Again, the FDA was forced to respond to the inventor’s attempts to impugn the safety of the Bair Hugger, by issuing a letter endorsing the continuing use of forced-air warming devices and the beneficial effect of such devices on patient safety. 


We remember once hearing a jury consultant say that every product liability lawsuit is a romance novel.  The story goes like this: you seduced me, you harmed me, and now you have abandoned me.  Well, this normothermia saga is the weirdest kind of romance novel.  It as if the Hotdog inventor was stalking the Bair Hugger, mixing entreaties of “marry me” with the most hateful invectives and assaults.  Fabio is nowhere in sight.  Even the Lifetime Network would take a pass on this improbable narrative.


Naturally, this narrative culminates in mass litigation.  Augustine and his law firm saw 60 cases get filed in Minnesota state court and thousands of cases in federal court.  Those cases rested on a three-legged stool of three iffy general-causation medical expert opinions.  Notably, “[n]one of these experts had studied the efficacy of forced-air warming devices prior to being retained by Plaintiffs. They have not published any peer-reviewed articles relevant to the claims made in this litigation. They do not claim that their general-causation opinions are generally accepted within the relevant scientific community.”  The experts were named Samet, Stonnington, and Jarvis, and odds are that you have encountered at least one of them in the long inglorious history of plaintiff experting.  You will hardly be surprised to hear that the defendants argued that the opinions were not generally accepted within the relevant scientific community and, therefore, were inadmissible under Minnesota law.  There was no mention of Daubert, since Minnesota is not a Daubert state. Don’t worry; Daubert was not needed. 


The plaintiffs’ only argument to save the expert opinions was that the general-acceptance requirement does not apply to an expert’s opinion. Rather, the standard applies only to the “methodology” an expert uses to arrive at his or her opinion.  We have to give the plaintiffs credit.  They placed their finger on the key issue in many Frye jurisdictions.  What has to be generally accepted, the bottom-line, ultimate opinion, or the methodological bits utilized to arrive at that opinion? Mind you, it’s not as if separating one from the other is perfectly obvious. The Minnesota court consulted both precedents from its own state as well as a Florida case desperately seized upon by the plaintiffs, and then announced its own bottom-line, ultimate opinion: the opinion itself, not just the methodology, must find general acceptance.  The general-acceptance prong under Minnesota law applies to “opinion or evidence” that “involves novel scientific theory,” and requires that the “underlying scientific evidence” be generally accepted.  The opinion that forced-air warming devices increase the rate of surgical site infections “is undisputedly novel and not generally accepted. Plaintiffs’ attempt to narrowly apply the rule must be rejected.”  The court reasoned that if the plaintiffs’ “interpretation were applied to its extreme, a witness would be able to opine that the earth is flat, or the center of the universe, if the person’s methodology for arriving at those opinions was generally accepted.”  True, and one can be sure that such extreme application will show up before the year is out. Interestingly, the Minnesota court quoted an earlier Minnesota precedent to the effect that the application of the Frye [in Minnesota it is called FryeMack] standard “avoids the problem that many commentators see as inherent in Daubert, namely, that such an approach “takes from scientists and confers upon judges *** the authority to determine what is scientific.”  But when most other courts praise the superiority of Frye, it is whilst they are in the process of waving by junk science.  What is so important and powerful about this decision is that it shows how Frye can be applied to bar junk science at the courthouse steps.  You should definitely have this opinion in your pocket the next time you visit Minnesota.  You should probably use it in any Frye jurisdiction.  You can probably exploit it here in the Commonwealth of Pennsylvania, where we have heard references to “Fraubert.”  Heck, you can probably be clever enough to use this opinion in the right circumstances in a Daubert jurisdiction.   


By the way, there was a second argument supporting summary judgment for the defendants. (When you win in the trial court, there is nothing better than provision of alternative grounds by the court.  It makes the appellate adventure so much more pleasant.)  Even if the general-causation opinions of the plaintiffs’ experts were admissible, the plaintiffs “have failed to establish that it is generally accepted that the risk of infection associated with forced-air warming devices is greater than the risk of infection associated with hypothermia during surgery or when compared to other warming devices.”  It is a double whammy.  There was no generally accepted scientific evidence that the risk of infection associated with forced air normothermia devices was greater than that associated with patients who are not warmed during surgery, and there is no scientific evidence that warming devices other than forced air warming devices have a lesser rate of infection.  There is no there there.


After an application of Frye so robust as to call to mind former Minnesota Governor Ventura, the court ends by dispensing a couple of other goodies to the defense bar.  First, the court praises the general acceptance test because it “values the primacy of science over litigation-driven opinion by allowing the medical and other scientific communities to abide by those generally accepted practices that promote patient safety, and marginalizes the effect of other opinions and efforts that might be unduly influenced by litigation and/or competition.”  Or, as we’ve said more than once before, law must lag science, not try to lead it.  (Thank you, Judge Posner.)  Second, the court observes that “the history leading to this litigation also demonstrates the importance of the general-acceptance standard when the threat or fear of litigation is used as a competitive tool.”  Amen. But while the abuse of science is especially obvious in this case, it exists in some significant form in most drug or device litigations, whether or not a vengeful inventor or romantic pursuer lurks just offstage.



This post is from the non-Reed Smith side of the blog.

Last week when we posted about some motion in limine rulings coming out of the IVC Filters MDL, most of our blogging team were enjoying a calm week after being hit by two nasty Nor’easters. We were turning our thoughts to spring. Birds chirping, flowers blooming, sunshine and rainbows. Now a week later as we officially head into spring, bam. Here we go again. The predictions vary and it may only be a few more inches of snow, but March has pretty been all lion and we really hoping to see a little lamb in our future. Mother Nature has decided she’s not quite ready to let go of her grasp on winter. Much like the court in the IVC Filter MDL wasn’t quite ready to let go of the bellwether case Jones v. C.R. Bard, Inc, 2018 U.S. Dist. LEXIS 40020 (D. Ariz. Mar. 12, 2018).

At the heart of the Bard IVC Filters Litigation is an allegation that defendant’s filters have a higher comparative risk rate than other filters and that defendant failed to warn physicians about the higher risk. Id. at *319-20. In the context of this bellwether case set for trial in May, defendant moved for summary judgment on failure to warn, misrepresentation, negligence per se, and punitive damages and won on misrepresentation and negligence per se.

The court was applying Georgia law and therefore the learned intermediary doctrine. Id. at *322-23. Defendant’s first argument was that plaintiff lacked proof of proximate cause on her failure to warn claim because her surgeon testified that he did not read the Eclipse filter label. You all know this argument – even if the defendant had included the very warning plaintiff contends should have been made, it doesn’t matter if the physician wouldn’t have seen it. If the doctor’s testimony is clear, this should shut the door on failure to warn. The court here, however, found a way to prop that door back open by holding that a defendant can breach its duty to warn not only by having a deficient warning but also “by failing to adequately communicate the warning.” Id. at *324. The court looked beyond the label to “dear doctor letters, product pamphlets, and statements by company sales representatives.” Id. at *325. If this is an escape hatch for plaintiffs on failure to warn, then we have more questions for doctors at their depositions.

Defendant’s second argument on failure to warn causation was that the physician was already aware of the very risk which occurred in this case, device fracture – which was also a well-known risk in the medical community. Id. at *326-27. Plaintiff’s countered that the lack warning wasn’t about the general risks of filters but that this particular filter had a higher risk of complication than other filters. On this point, plaintiff’s surgeon testified that higher complication rates is something “he would have wanted to know” before plaintiff’s surgery. That was enough for the court to find a jury question as to prior surgeon knowledge. Id. at *328.

Taking these two rulings together serves to emphasize the critical importance of the physician’s deposition. This court wanted “unequivocal” evidence that the doctor would have made the same prescribing or surgical decision even in the face of different warning information. Id. at *328-29. Only such a response would have cutoff causation with regard to any avenue by which the defendant could have communicated warnings to the surgeon. It’s a risk to ask the ultimate question – would a different warning have mattered – but without it, the risk is a disputed fact issue for the jury.

The court turned next to the adequacy of the warning provided, which it was undisputed did contain a warning regarding fractures. But as noted above, did not contain information about the comparative risk rates for this filter as against other filters. Id. at *330-31. We had the same gut reaction that defendant in this case appears to have had – 1) how can you possibly provide reliable information comparing risks among products and 2) is this even allowed by the FDA. Id. at *334. It’s not for prescription drugs. See 21 C.F.R. §201.57(c)(7)(iii) (“For drug products . . . any claim comparing the drug . . .with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”). But the same logic should apply. Unless the adverse reactions or complications being discussed have been studied side-by-side to account for variables and assorted other unknowns, the comparison is meaningless and potentially more harmful than helpful. It’s one thing to suggest that the label warning of the risk of fractures was insufficient given the state of knowledge defendant had or should have had at the time, but finding that a defendant could be liable for breaching its duty to warn for failing to provide comparative risk rates that are unverified, unapproved, and inherently unreliable puts a defendant in a really precarious position. Don’t include and face tort liability; include a face FDA violations for misbranding and misleading information.

Moving on to the two claims that were dismissed – misrepresentation and negligence per se. The court found that Georgia does not recognize an independent claim for misrepresentation in a products liability case. It is subsumed in failure to warn. Id. at *336-37. Similarly, plaintiffs could not maintain a negligence per se claim based on alleged FDCA violations because there is no private right of action to enforce the Act. The court’s preemption analysis is emphatic and strongly reasoned. Id. at *338-40. Plaintiff’s attempt to sidetrack the court with talk of the difference between PMA and 510(k) devices falls on deaf ears, as it should when talking about Buckman implied preemption. Id. at *340-41. As did plaintiff’s attempt to argue that Georgia allows negligence per se claims based on laws that do not create a private right of action. The difference between those laws and the FDCA is “the plain language of §337(a) and the Buckman decision indicate that, where the FDCA is concerned, such [a] claim fails.” Id. at *341.

Finally, the court also allowed plaintiff to keep her punitive damages claim based on a design claim that was not otherwise part of the motion. The discussion focuses on the state of the evidence regarding what defendant knew and when and what actions it took regarding the design of the device at issue. It is fairly case specific and so we won’t delve into the details here.

Not a banner decision and frankly it raises more questions than it answers about warnings based on comparative risk rates. Hmm, perhaps a deeper dive and a subsequent post is in order. Something for the next snowy day.


Stephen Hawking may have been the smartest guy in the world, even though he believed that “People who boast about their I.Q. are losers.”  Hawking is best known for his work on black holes.  As used in physics, a black hole describes a point-sized mass (called a “singularity”) so dense that its escape velocity exceeds the speed of light.  That effectively cuts it off from the rest of the universe, so that nothing emanates from it – hence the “black hole” terminology.  Hawking’s study (more than “study,” really since he thought most of these things up) applied the black hole concept to the entire universe, thus providing a theoretical underpinning for “Big Bang” cosmology.  Beyond that, Hawking developed laws of black hole mechanics.  He dealt with rotating black holes, and determined that contrary to their initial definition (and Hawking’s own prior work) black holes could under some circumstances emit radiation due to annihilation of particles near the event horizon (it’s complicated – you can access Hawking’s many and varied ideas here).  That radiation is now called “Hawking radiation,” and over cosmological time (trillions of years or longer) can cause black holes to evaporate and eventually explode.

He will be missed.

The massive gravity of black holes sucks in everything surrounding them and crushed it into effectively nothing but mass and spin.  We immediately thought of black holes in the legal context when we learned on Friday that the Massachusetts high court (called the “Supreme Judicial Court”) decided to recognize a form of innovator liability – imposing liability for injuries caused by generic drugs on their branded competitors. See Rafferty v. Merck & Co., ___ N.E.3d ___, 2018 WL 1354064 (Mass. March 16, 2018).

As we had feared, California did this first, adopting an extreme – even more extreme than usual − version of innovator liability in T.H. v. Novartis Pharmaceuticals Corp., 407 P.3d 18 (Cal. 2017).  In Hawking’s parlance, that would make the state a “supermassive” legal black hole.  Massachusetts isn’t as big a state, and its innovator liability theory isn’t as downright bizarre as California’s, so Rafferty probably created an intermediate-mass legal black hole.  But liability for injuries caused by products that the defendant never even made (and thus made no money from) is potentially crushing to innovator drug companies no matter what.

So what exactly did Rafferty hold?

For one thing, much more than in T.H. the Massachusetts court was quite frank that it was only doing this because preemption prevented plaintiffs purportedly injured by generic drugs from suing generic manufacturers.  There was none of this bullhockey that we got from California about innovator liability stemming from well-established negligence principles.  Before ever getting to state-law issues (or even to the facts of the case) Rafferty identified generic preemption as the problem:

This allocation of labeling responsibilities under Federal law has proved difficult to reconcile with the duties required of generic drug manufacturers under State tort law. . . .  Under Federal regulations . . . manufacturers of generic drugs − because they lack the power to change the warning labels on their products unilaterally − cannot independently fulfil these State law duties. . . .  The practical consequence is that a consumer who suffers injury arising from an inaccurate or inadequate drug warning label can sue the manufacturer for damages caused by his or her injury only if the consumer ingested a brand-name version of the drug — but not if the consumer ingested the generic version.

2018 WL 1354064, at *2 (citations omitted).  For this reason, innovator liability could not exist as a product liability claim as “product liability” is normally understood:

[U]nder our prevailing law, . . . [defendant] owes [plaintiff] no duty to warn under the law of products liability.  As noted by the judge, a manufacturer may be found liable for a failure to warn only where the product that caused the injury was made by that manufacturer; its duty of care extends only to users of its own product.

Id. at *3 (discussion of several prior Massachusetts product liability cases omitted).  Unlike California, Rafferty held that there was no basis for innovator liability in product liability (including ordinary negligence), or the Massachusetts consumer fraud statute.  See also Id. at *13 (discussing consumer protection).

But in today’s day and age, at least in Massachusetts or California, a result that produces no liability against anyone is apparently intolerable.  Thus, the court in Rafferty, using its common-law powers, made something up – product liability for “recklessness.”  Rafferty turned to “a general principle of tort law,” hitherto unknown in product liability, that “[e]very actor has a duty to exercise reasonable care to avoid physical harm to . . . all persons who are foreseeably endangered by his conduct, with respect to all risks which make the conduct unreasonably dangerous.”  Id. at *5 (quoting Jupin v. Kask, 849 N.E.2d 829, 835 (Mass. 2006)).  And what did Jupin quote for this broad, vague declaration of anyone potentially liable to everyone for anything?   Not any Massachusetts case, but rather Tarasoff v. Regents, 551 P.2d 334, 344 (Cal. 1976).  Argh‼  Even though we’re in Massachusetts, the principles of crazy California tort law are still around, expanding liability.

However, unlike the California Supreme Court, Rafferty was at least willing to “recognize[] . . . that, even where the requirements of negligence are satisfied, there may nevertheless be a public policy justification for declining to impose a duty of care where “the imposition of a precautionary duty is deemed to be either inadvisable or unworkable.”  2018 WL 1354064, at *5 (citation and quotation marks omitted).  But while “in the vast majority of . . . cases, the duty to warn would be limited to the manufacturer of the product − even if the plaintiff were to bring a general negligence claim − because the risk of harm arising from an inadequate warning would be foreseeable to a manufacturer only with respect to users of its own product,” id. at *6, prescription drugs were different, because to comply with the FDCA, innovator manufacturers are required to let generic manufacturers use their labels verbatim.

With generic drugs, it is not merely foreseeable but certain that the warning label provided by the brand-name manufacturer will be identical to the warning label provided by the generic manufacturer, and moreover that it will be relied on, not only by users of its own product, but also by users of the generic product.

Id. at *6 (emphasis original).  Innovator liability thus exists to make innovator manufacturers pay for having complied with the “require[ments]” of the regulatory scheme imposed by the “Hatch-Waxman amendments,” and for no other reason. Id.

Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product, but also the users of the generic product.  Consequently, this is the rare (perhaps the only) type of case involving a manufactured product where the requirements of general negligence may be satisfied even where the requirements of products liability are not.

Id. at *6 (emphasis added).

“Perhaps the only” – there it is, a unique, expansive duty imposed on a non-manufacturing innovator pharmaceutical company because its FDA-approved warning is deemed inadequate under state law, with the duty expanded to include generic drug users because the defendant is forced by Hatch Waxman to let generic manufacturers (who are equally subject to the federal requirement) use its labeling verbatim.  Under Rafferty, innovator liability is a consequence of a branded drug company’s compliance with the FDCA, and nothing else.  In and of itself, this massive transfer of liability based on conformity with the requirements of federal law raises serious preemption issues.

Back to Rafferty’s rationale.

Unlike California, the Massachusetts court in Rafferty at least had the good sense to recognize that there were countervailing public policy considerations implicated by making a drug manufacturer liable for injuries caused by competing products:

[I]f consumers of generic drugs were allowed to recover damages for a brand-name manufacturer’s negligent failure to warn, it would be far more difficult for the manufacturer to shoulder these costs, for three reasons.

First, these costs would not be incurred until after the brand-name manufacturer’s patent monopoly expires and generic competitors enter the market, at which point the brand-name manufacturer will have suffered a precipitous decline in sales of its product. . . .

Second, because prices drop with generic drug competition, the sales of generic drugs may exceed the sales generated during the patent monopoly period, and may even continue indefinitely, long after the brand-name manufacturer has moved on to focus on other patented products. . . .

Third, because . . . [f]ederal preemption bars any generic drug consumer from bringing a failure to warn claim against any generic manufacturer, all such claims would be brought only against the brand-name manufacturer . . ., leaving the brand-name manufacturer without any ability to share the costs of litigation, or of a damage award or settlement, with the generic manufacturer.

Rafferty, 2018 WL 1354064, at *7-8 (citations and quotation marks omitted).  Innovator manufacturers are thus “not in the best position to bear its [innovator liability’s] costs.”  Id. at *8.  Such liability “impose[s] on brand-name manufacturers an additional ‘cost of production’ for products that, in reality, they no longer produce.”  Id.

What is a “cost of production” for a “product[] that, in reality [is] no longer produce[d]”?  Quite frankly, it is a cost that must inevitably be inequitably recouped, because the only way a drug manufacturer will pass along that cost is to consumers of other, non-defective products.  With all the brouhaha lately about reducing the price of prescription drugs, innovator liability is a recipe for increasing those costs substantially.

[A]s a matter of public policy . . . allowing a generic drug consumer to bring a general negligence claim for failure to warn against a brand-name manufacturer poses too great a risk of chilling drug innovation, contrary to the public policy goals embodied in the Hatch-Waxman amendments.

Id. at *10.

Nonetheless, liability uber alles prevailed.  Precedent be damned.  Id. at *11 (“we find ourselves in the minority of courts that have decided this issue” – see our scorecard).  “The widespread use of generic drugs means that, if we decline to impose any liability on brand-name manufacturers, countless consumers would be left without a remedy.”  Rafferty, 2018 WL 1354064, at *9.  Rather than letting the state legislature (let alone Congress, which enacted Hatch-Waxman) balance large-scale public policy concerns, Rafferty created innovator liability for “reckless” conduct:

In other types of cases where we have circumscribed liability for public policy reasons, we have nevertheless consistently recognized that there is a certain core duty − a certain irreducible minimum duty of care, owed to all persons − that as a matter of public policy cannot be abrogated: that is, the duty not to intentionally or recklessly cause harm to others.

Id.  Thus, Rafferty professed to “tolerate[] ordinary negligence but draw[] the line at recklessness.  Id.

But did it really?  There are two types of “reckless” conduct, as explained in Restatement (Second) of Torts §500 (1965) (defining “reckless disregard”).  One is where the “actor knows, or has reason to know, . . . of facts which create a high degree of risk of physical harm to another, and deliberately proceeds to act, or to fail to act, in conscious disregard of, or indifference to, that risk.”  The second is where the “actor has such knowledge, or reason to know, of the facts, but does not realize or appreciate the high degree of risk involved, although a reasonable man in his position would do so.”  Id. comment a.  The second of these is really just a glorified type of negligence.  “An objective standard is applied . . ., and [the actor] is held to the realization of the aggravated risk which a reasonable man . . . would have, although he does not himself have it.”  Id.

Rafferty chose the second, dumbed-down version of “reckless disregard,” using the Restatement’s weak alternative definition of recklessness:

[H]e does an act or intentionally fails to do an act which it is his duty to the other to do, knowing or having reason to know of facts which would lead a reasonable man to realize, not only that his conduct creates an unreasonable risk of physical harm to another, but also that such risk is substantially greater than that which is necessary to make his conduct negligent.

Rafferty, 2018 WL 1354064, at *10 (quoting a case that quotes from Restatement §500) (emphasis added).

Under this standard, a brand-name manufacturer that intentionally fails to update the label on its drug to warn of an unreasonable risk of death or grave bodily injury, where the manufacturer knows of this risk or knows of facts that would disclose this risk to any reasonable person, will be held responsible for the resulting harm.

Id. at *11 (emphasis added).  At least the “fails to update” language seems to limit liability to current NDA holders, which is some improvement on the even more malignant California style of innovator liability.

Is Rafferty’s “recklessness” standard really going to contain the evil genii of innovator liability that has been let out of the bottle?  We aren’t holding our breath.  Our brethren on the other side of the “v.” have proven time and time again to be willing and able to allege whatever is necessary to state whatever cause of action they have to, whether or not the facts support it.  Then they file hundreds or thousands of cases until the defendant settles rather than risks catastrophic liability – the legal “black hole” we mentioned at the outset of this post.  Thus, we are skeptical, to say the least, of Rafferty’s assurances that this novel form of liability “will not materially chill innovation or increase drug prices.”  Id. at *12.  While Congress “in enacting the Hatch-Waxman amendments . . . expected that its Federal regulatory scheme would be supplemented with traditional State law remedies,” id., innovator liability, is anything but “traditional,” as indeed Rafferty itself recognized in the course of reaching its admittedly “minority” result.

Back when we first encountered mass torts in the prescription medical product context we realized that, as plaintiffs created new theories of liability, it was up to us to create new defenses to counter them.  That’s how Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), came to be.  We’ll see what we can come up with this time.  After all, as Stephen Hawking himself said, “[i]ntelligence is the ability to adapt to change.”

The district judge in the In re Zimmer Nexgen Knee Implant Products Liability Litigation MDL issued a summary judgment order in October 2016 that we called “the best Wisconsin law decision we have ever seen.”  What was the reason for our unusually unbridled enthusiasm?  The district judge debunked the idea that the learned intermediary rule does not apply in Wisconsin.  We have often heard that refrain, but we have always been skeptical.  The truth is that Wisconsin’s appellate courts have not addressed the issue, and the In re Zimmer Nexgen judge predicted that Wisconsin’s Supreme Court would adopt the learned intermediary rule if given the opportunity.

The Seventh Circuit has affirmed that order, so its opinion now inherits the mantle of “Best Wisconsin Law Decision We’ve Ever Seen.” That title is cemented not only by the adoption of the learned intermediary doctrine, but also the rejection of a heeding presumption, which is also very helpful.  We note that the three judges who issued this opinion have spent a combined 83 years on the Court of Appeals and that the author of the opinion spent five years on the Wisconsin Supreme Court.  Maybe the latter fact was considered when assigning the opinion; maybe it was not.  Regardless, it is a clear-minded and well-reasoned opinion that we commend to anyone who has grappled with warnings claims in Wisconsin.

Here is what happened. The plaintiff sued a knee implant manufacturer alleging design, manufacturing, and failure-to-warn claims after his prosthetic knee replacement loosened, which is a known complication of all joint replacement procedures. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., No. 16-3957, — F.3d –, 2018 WL 1193431, at *1 (7th Cir. Mar. 8, 2018).  Following summary judgment, the plaintiff raised only the warnings claims on appeal and argued that the manufacturer failed adequately to warn both the plaintiff and his surgeon.

Of course, an alleged failure to warn the plaintiff raises the application of the learned intermediary rule, which “holds that the manufacturer of a prescription drug or medical device fulfills its duty to warn of the product’s risk by informing the prescribing physician.” Id. at *2.  Because neither the Wisconsin Supreme Court nor the state’s intermediate appellate courts have addressed the rule, the Seventh Circuit undertook an Erie analysis. Id. at *3.

Although we would like to believe that the Seventh Circuit reviewed our frequently updated 50-state survey on the learned intermediary rule, it is more likely the court did its own research or relied on that provided by the manufacturer.  What it found was one Wisconsin trial court opinion applying the doctrine and noting its widespread acceptance. Id. at *3 (citing Staub v. Berg, No. 00-cv-0117, 2003 WL 26468454 (Wis. Cir. Ct. Jan. 6, 2003)).  The Court also found three federal district court opinions invoking the learned intermediary doctrine under Wisconsin law, and one case called Maynard v. Abbott Labs observing that “Wisconsin does not apply the learned intermediary doctrine.” Id. On this last point, the Seventh Circuit was particularly blunt:  “That statement is incorrect—the Wisconsin Supreme Court has never weighed in on the topic [and] Maynard itself is bereft of any analysis on the point.” Id.

The Seventh Circuit also relied on the learned intermediary doctrine’s “broad support in other jurisdictions,” including 48 states where the highest court or the intermediate appellate courts have adopted the doctrine in some form. Id. Finally, the rationale for the learned intermediary rule applies even more forcefully in cases involving surgical implants because “it is not reasonably conceivable that an individual could obtain and implant a device that requires a trained surgeon without the intervention of a physician.” Id. Amen.

The following holding and the reasoning upon which it is based are what make In re Zimmer Nexgen the Best Wisconsin Law Opinion We’ve Ever Seen:

In short, there is good reason to think that given the opportunity, the Wisconsin Supreme Court would join the vast majority of state supreme courts and adopt the learned-intermediary doctrine for use in defective-warning cases like this one involving a surgical implant. We predict the state high court would do so.  Accordingly, to the extent that [the plaintiff’s] defective-warnings claim is based on [the manufacturer’s] duty to warn him, it is foreclosed by the learned-intermediary doctrine.

Id. at *4.  For good measure, the Seventh Circuit held that the plaintiff’s direct warnings claim failed also because the plaintiff did not identify any danger about which that the manufacturer should have warned him and because he had no evidence of causation.  Even if the plaintiff would have heeded a different warning, “[he] didn’t select the NexGen Flex implant.”  His surgeon did.  Id.

The Seventh Circuit likewise rejected the plaintiffs’ argument that the manufacturer failed adequately to warn the surgeon.  The plaintiff cited the defense expert’s testimony that he would have used more cement to place the implant and argued that the manufacturer failed to warn about the amount of cement needed. Id. at *4.  But that was not sufficient because “no evidence supports [the plaintiff’s] contention that it was [the manufacturer’s] responsibility to instruct surgeons about the amount of cement they should use.” Id. at *5.  This surgeon relied exclusively on his education and training, not on any materials from the manufacturer, and the plaintiff offered no expert opinion that the warnings were inadequate in any event. Id.

Finally, the Seventh Circuit rejected the warnings claims on causation. The surgeon did not read the instructions for use and could not been affected by a different warning. Id. at **5-6.  The plaintiff urged the Seventh Circuit to apply a “heeding presumption,” i.e., a presumption in the absence of proof that the surgeon would have read and heeded a proper warning. Id. at *5.  But Wisconsin law squarely places the burden of proving causation on the plaintiff.  As the Seventh Circuit held,

Here again, the state appellate courts have not addressed this doctrine [the heeding presumption]. We seriously doubt that they would adopt it in this context.  [¶]  To the contrary, as we’ve already noted, the state court of appeals has recently held that “[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury.”

Id. (citing Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. Ct. App. 2004)).  In other words, since Wisconsin law already places the burden of proving causation on the plaintiff, the Seventh Circuit would not alter that law by creating a presumption.

The plaintiff’s last request was to certify questions to the Wisconsin Supreme Court, which the Seventh Circuit rejected because “[n]o genuine uncertainty exists here.” We could not agree more and would not be surprised to see this opinion on our Ten Best list at year end.

Here in Philadelphia, less than a week before the first day of Spring, it is sunny and calm, albeit a bit chilly. Not so last week, when we were hit with the second Nor’easter in less than a week.  As much as sixteen inches of snow fell in some suburbs, and thousands of people, some of whom had just regained electric power after the last storm, were knocked into the dark and cold when tree limbs felled by heavy snow took power lines with them.  For the second time in as many storms, we found ourselves in a pocket on the low end of predicted accumulations.  We only got about six inches of snow, and it started melting quickly when temperatures rose in the evening.  And, again, our end of the street did not lose power.  (Assuming cooperation from the technology gods, this no longer affects us, as we happily parted with some retirement savings a few years ago in favor of a whole-house generator, after a four-day outage during which we tested long-held friendships by descending with the Drug and Device Law Menagerie in tow.)  The only “blip” was a scary near-miss.  We were out walking the Drug and Device Law Little Rescue Dogs at the height of the storm when a huge tree limb crashed down on a spot where we had stood ten seconds earlier.  Reminds us not to sweat the small stuff – this could have been tragic.

But save for that significant footnote, it was all pretty good.   And our assessment of today’s decision is similar.  In In re Bard IVC Filters Prods. Liab. Litig., 2018 WL 1109554 (D. Ariz. Mar. 1, 2018), the court ruled on a number of motions in limine in advance of a mid-March trial.  The plaintiff alleged that she was injured when defendant’s filter, inserted in her inferior vena cava (“IVC”) to capture blood clots, migrated and fractured.  The filter that was implanted in the plaintiff, a Class II device, was granted 510(k) clearance by the FDA because of its “substantial equivalence” to an earlier filter model the defendant had marketed.  And that is the source of the most interesting rulings.

Defendants’ Motion to Exclude Evidence of Complications Associated with Predicate Device

Earlier, the plaintiff had moved to exclude evidence of the 510(k) clearance process, a motion that the defendants “vigorously opposed.” In re Bard IVC Filters, 2018 WL 1109554 at *1.  The court agreed with the defendants, “noting that the FDA grants 510(k) clearance only where the device is as safe and effective as a predicate device and does not raise different questions of safety and efficacy than the predicate device.” Id. (internal punctuation and citations omitted).  As such, compliance with the 510(K) clearance process was “certainly probative under Georgia law on the issues of reasonableness of the design, manufacture, and warnings of the [cleared filter]” as well as issues related to the plaintiff’s punitive damages claim. Id. Georgia law, hmmmm…. The Fourth Circuit’s Cisson misstep, going 180° the other way, was also Georgia law, as we discussed here.  Needless to say, we like this one better.

But having fought for admission of evidence of the 510(k) clearance process, the defendants were faced with the plaintiff’s intention to introduce evidence of complications with the predicate device. The defendant moved to exclude this evidence, arguing that the complications were not “substantially similar” to the issues the plaintiff experienced with her device.  The defendant argued that, ‘[b]ased on clinical experience with the [predicate] filter, [it] made several significant changes to the [new] filter.” Id. Because the plaintiff received the new filter, which had been “changed significantly” from the predicate device, the defendants argued that problems with the predicate device  had no relevance to the plaintiff’s case.

The court denied the motion, noting that the defendant had “avowed to the FDA that the design, material, components, fundamental technology, . . . and intended use featured with the [new filter] are substantially equivalent to those featured with the predecessor [filter].” Id. The defendants further asserted that “one of [the] goals in developing the [new] filter was to reduce the number of incidents of filter fracture and migration that [it] had observed with the [predecessor].” Id. The court concluded, “Given these facts, . . . [the defendant’s] knowledge of problems with the [predecessor filter] is relevant to central issues in this case” – whether the defendant properly designed the new filter to correct the problems, whether it failed to properly warn about the problems, and whether its conduct justified an award of punitive damages. Id. at *2.

This ruling presents a quandary. We have spent many years defending manufacturers of Class 2 medical devices and advocating for admission of evidence of 510(k) clearance. We can appreciate the tension and the difficulty of drawing appropriate evidentiary lines.  But evidentiary lines and regulatory requirements are different.  This is a variant of the same fallacy underlying the 510(k) admissibility point discussed above.  FDA regulatory requirements and admission of evidence in civil litigation are two different things, created for different purposes, and often don’t mix well.

That is true here. For one thing, there is more to 510(k) than just substantial equivalence (“SE”).  The entire relevant part of the FDCA allows for an SE finding where the device being considered:

(ii)(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by [FDA] that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.

FDCA §513(i)(1)(A) (emphasis added), So a substantial equivalence finding by the FDA does not mean that the predicate device is technologically the same – or necessarily even close – as long as it “does not different questions of safety and effectiveness.”  That’s a lot different from the “substantially similar” standard generally used for admission of other occurrence evidence.

Admission of evidence of 510(k) clearance should not automatically open the floodgates to evidence of problems a plaintiff didn’t’ experience with a device she didn’t receive. The other occurrence could well arise from a “different technological characteristic.”  That would require a deeper dive into the regulatory pedigree of the device than occurred here.  We are thinking about this issue for a future post. Meanwhile, here are some highlights of the court’s less complicated rulings:

Defendants’ Motion to Exclude FDA Warning Letter

The defendants moved to exclude an FDA warning letter because: 1) it was an “informal advisory statement” by FDA; 2) it was issued more than seven years after the plaintiff received her IVC filter; and 3) the specific topics in it were not related to the filter the plaintiff received or to any issue in the case. Id. at *3.  The plaintiff countered that the letter was evidence to counter the defendant’s assertion that the FDA had never expressed concern about the defendant’s filters or taken any action against the defendant.   The court held that several sections of the warning letter lacked probative value because they addressed topics that were not at issue in the litigation.   Others addressed a generation of filter that was developed after the filter the plaintiff received.  The court granted the motion in limine with respect to those topics, but reserved for trial the question of the admissibility of topics related to the defendant’s handling and reporting of filter failures.  The court did conclude that, if the letter should become relevant at trial, it would be admissible under the public records exception to the hearsay rule.  Whatever happens later, the defendant’s first point about warning letters being “informal” and “advisory” was spot on.  We examined that issue in great detail here and here.

Plaintiffs’ Motion to Exclude References to IVC Filters as “Lifesaving” Devices.

The plaintiff sought to preclude the defendants from “putting on a ‘filters save lives’ defense” or from describing the filters as “lifesaving” or “life-extending.” Id. at *4.  The court denied the motion, holding that, under Georgia’s risk-utility analysis, “evidence concerning the benefits of IVC filters is directly relevant. . . .”

Plaintiffs’ Motion to Exclude “Standard of Care” Evidence

The plaintiffs sought to exclude the defendants from presenting evidence that IVC filters are “within the standard of care for medical treatment of pulmonary embolisms.” Id. at 5 (citations omitted).   The court denied the motion, agreeing with the defendants that “evidence regarding the use and benefits of IVC filters, and when they are called for, will be relevant to the jury’s risk-utility analysis, as well as evaluation of the failure to warn claims and [the surgeon’s] decision to implant” the defendant’s filter in the plaintiff. Id. In response to the plaintiffs’ concern that the jury could be confused about the standard of care to apply, the court conceded that “the standard of care for . . . design and marketing of IVC filters is entirely different from the medical standard of care for when filters should be used to treat patients.” Id. As such, the court held, the parties should refer to the “medical standard of care” when referring to the standard for implanting the filters, and should seek a clarifying instruction if warranted.

Plaintiffs’ Motions: “Nonparty at Fault” and “Intervening Cause”

Under Georgia law, a defendant may identify a “non-party at fault” and present evidence of that party’s fault to the jury. The jury may then include the non-party in its apportionment of fault and damages.  In this case, the defendant identified a diagnostic radiologist as the only “nonparty at fault,” alleging that the radiologist’s failure to report the condition of the filter to the plaintiff’s physicians was a cause of the plaintiff’s injuries.  While this was the only non-party whose fault the defendants intended to prove to the jury, the defendants argued that they should be permitted to introduce other doctors’ conduct, under a separate legal doctrine, as “intervening causes” of the plaintiff’s injuries, breaking the chain of causation between the defendant and the plaintiff and relieving the defendant of liability under Georgia law.  The plaintiffs moved to exclude evidence that  doctors not identified as “nonparties at fault” were “intervening causes” of the plaintiff’s injuries.  The court denied the motion, holding “. . . [A]lthough Defendants will be precluded from arguing that [other doctors] were negligent or at fault for purposes of apportioning liability, the Court cannot say that they should be precluded from asserting the fault of these nonparties as an intervening cause” of the plaintiff’s injuries.  The court emphasized that it would be careful to instruct the jury about the distinction between the two doctrines.

Plaintiffs’ Motion to Exclude Statements from Professional Associations

The plaintiffs sought to exclude evidence of statements of professional associations, trade groups, societies of physicians, and the like, arguing that the statements were hearsay, and, introduced through non-experts, would “evade Daubert scrutiny and would violate Rule 403.”  The court reserved its rulings for trial, holding that it could not grant the motion because the plaintiffs did not identify particular statements.  But it held that, on the present record, it could not conclude that the probative value of certain statements was outweighed by the potential for prejudice or that testimony about the absence of certain statements constituted inadmissible hearsay.  We see an analogy to how the federal rules treat learned treatises for hearsay purposes.

All in all, a pretty good day, with the exception of the quandary created by the rulings related to the admissibility of 510(k) evidence. That one isn’t as black and white as the ruling that was made.  We will keep you posted.

With a little luck on our part, by the time you read this we will be vacationing in a sunnier clime.  Our beachfront cottage is an Oddjob’s hat-toss away from where Ian Fleming wrote the James Bond novels.  Mind you, we are not pretending to be serving On Her Majesty’s Secret Service.  If anything, with the secluded location of our holiday, the absurd luxury, and our ever-expanding girth, we are more appropriately cast as a Bond villain.  That suits us just fine.  More than one plaintiff lawyer has called us Dr. No. And more than once, we have reached under our desk, probing for a trap-door button that would plunge an opponent into the piranha pool.

The judge in today’s case, Livingston v. Hoffman-LaRoche Inc., No. 17C-7650-MEA (N.D. Ill. March 7, 2018), pushed the button, holding that there was no personal jurisdiction.  Livingston was yet another Accutane case, with allegations of bowel injury.  We have written frequently on the aggregated forms of this litigation in both the federal and New Jersey court systems.  The Livingston case is different.  To be sure, the Livingston opinion last week was largely an obvious application of the SCOTUS Bauman and BMS cases, but there was a scary threat lurking just off-stage.  More on that later.  Moreover, anything good on jurisdiction from Illinois is noteworthy.


The history of the Livingston case is more complicated than the plot of The World is Not Enough.  The case was originally filed in Cook County, Illinois – a fabulous pro-plaintiff jurisdiction.  The case was then removed.  Then it was remanded — nine years ago.  The case sat in state court with little happening.  The generics got out on Pliva v. Mensing in the meantime, but by then the branded defendant could no longer remove the case because of the one-year bar.  Then the plaintiff lawyers did the defense a great favor (not the last) by taking their one dismissal in Illinois, which allowed them to refile within a year.  The plaintiff eventually did refile in Cook County, and the branded defendant removed.  That’s the case in our sights today.  The case was initially assigned to a different judge, but then it got reassigned to the same federal judge who remanded a long time ago.  The defendant would have been entitled to view that as a bad sign.  But it wasn’t.

So much for foreshadowing.  Here are the facts, at least the ones that matter for this decision.  The plaintiff took Accutane to treat his acne in Wisconsin in 1999 and in Ohio in 2004.  In 2005, the plaintiff had a surgical procedure to remove his colon.  The gravamen of the plaintiff’s lawsuit is that Accutane made this surgery necessary.  More specifically, the plaintiff claimed that the product was defectively designed and was accompanied by inadequate warnings.  But we are getting ahead of ourselves.  The plaintiff moved to Illinois in 2007. There, he was prescribed a generic version of the drug that allegedly caused him the earlier harm, and the plaintiff asserted that his Illinois doctor committed malpractice.  It is because the plaintiff lived in Illinois that he filed his lawsuit there, even though the manufacturer of branded Accutane was not “at home” in Illinois and the branded prescription and the alleged injury occurred outside of Illinois.

It is thus no surprise that the branded defendant moved to dismiss for lack of personal jurisdiction.  The plaintiff filed no opposition.  The Livingston court references a reply brief filed by the defendant.  Presumably, that reply brief was one of those short, triumphal papers pointing out that the plaintiff’s silence amounts to a concession, so a ruling for the defendant should be compulsory and easy.  And, in fact, the dismissal for want of personal jurisdiction was compulsory and easy.  We’ve seen a report on this case in one of the major online legal publications, and for some reason that report focused on general jurisdiction.  That aspect of the decision is certainly the least interesting part.  The manufacturer of Accutane was not incorporated in Illinois and did not locate its headquarters there.  To our mind,  Bauman makes that a no-brainer.
No, for us there are two angles to the decision that are much more interesting.  First, the Livingston court followed what seems to be the emerging consensus rule for federal courts faced with simultaneous issues of subject matter jurisdiction (is there diversity?  is there fraudulent joinder?) and personal jurisdiction (can this particular defendant be sued by this particular plaintiff here?).  Plaintiffs would prefer the district court to handle the subject matter jurisdiction issue first, conclude that the defendant had not met the difficult test for fraudulent joinder, and then remand the case to state court without ever getting to personal jurisdiction.  Defendants would prefer the federal court to look at personal jurisdiction, find it does not exist, and then dismiss the case without ever getting to subject matter jurisdiction.  It turns out the defendants are right and the plaintiffs are wrong (you’re not exactly surprised to hear us say this, are you?) for a simple reason — literally a simple reason: the personal jurisdiction issue is simple, and the fraudulent joinder issue is not.  That is what the Livingston court concluded, alluding to the “enormous judicial confusion” engendered by the fraudulent joinder doctrine, while viewing the personal jurisdiction issue as being “straightforward” and not presenting “a complex issue of law.”  As addressed above, the general jurisdiction prong of personal jurisdiction truly was simple here: no incorporation or headquarters means no general jurisdiction.
The specific jurisdiction prong was almost as simple, though we are mindful that some plaintiff lawyers and some courts now seem determined to make it much less simple.  (We recently read of a court from one of the very worst jurisdictions deciding to tackle the subject matter jurisdiction issue first, because the plaintiffs had successfully muddied the personal jurisdiction waters.  We don’t recall the judge’s name.  Perhaps Blofeld?)  As SCOTUS set forth in Walden v. Fiore, to support the exercise of specific personal jurisdiction, “the defendant’s suit-related conduct must create a substantial connection with the forum state.”  Here, the plaintiff’s Accutane prescription and treatment occurred outside of Illinois.  Predictably, the plaintiff alleged that the branded defendant “marketed, distributed, and sold” Accutane all over the United States, including Cook County.  The answer to that is: So what?  That conduct played no role in the plaintiff’s injury.  What about the fact that the plaintiff does currently reside in Illinois?  Again, Walden supplies the refutation: “[T]he plaintiff cannot be the only link between the defendant and the forum.  Rather, it is the defendant’s conduct that must form the necessary connection with the forum state that is the basis for its jurisdiction over him.”  Go back and read the facts of the Walden case, and you will understand how the plaintiff’s residence, absent some connection to the defendant’s conduct, cannot unilaterally establish specific personal jurisdiction.  End of story.  Push the button. Cue the piranhas.

But there is one additional, potentially interesting aspect of this opinion.  The physician who prescribed the generic version of the drug was, in fact, a citizen of Illinois.  Again, the court regarded this as a big fat So-what:  “The claim against the local doctor did not mention the manufacturer of Accutane, involved the generic product only, “comprises different time periods, and entails different injuries.”  Swell.  But we must admit that as we read the final portion of the Livingston opinion, we were haunted by a spectre.  It is very, very nice that the bottom line of Livingston is that the prescription of a generic drug in Illinois did not create personal jurisdiction over the brand defendant. For a moment, though, a terrible dread wormed its way into our brain-pan.  We alluded above to the fact that Illinois is the home of some awful personal jurisdiction opinions.  Illinois has also been crazy-bad on the issue of innovator liability.  One might have feared that an Illinois court might contrive to find a way to merge innovator liability with the “arise out of”/”related to” prong of specific jurisdiction and thereby keep the case in Illinois. If a branded company can be on the hook for injury allegedly caused by a generic, why not require the branded company come to the forum where the generic was consumed.  An utterly crazy syllogism is at work there.  But Illinois is the one jurisdiction batty enough (well, along with California) to throw out all of tort and jurisdictional law on grounds of foreseeability and misplaced judicial compassion.  Such an outrageous opinion would have made the judicial sky fall. Mercifully, that did not happen in the Livingston case.  Indeed, now defendants have a precedent to argue that it never should.

We offer a tip of the cyber-cap to the winning lawyers, a defense all-star team including longtime friend-of-the-blog Michael Imbroscio (Covington), as well as Colleen Hennessey (Peabody), and Sherri Arrigo (Donohue Brown).

Today’s case isn’t about prescription drugs, but rather illegal drugs. More specifically, whether a user of illegal drugs can recover in a civil action against someone who failed to prevent the user from obtaining the drugs. While this is outside our usual field of focus, we have posted about the in pari delicto doctrine before and believe the decision could be analogously useful to drug companies in at least some types of opioid litigation and therefore worthy of notice.

You won’t find that fancy Latin phrase in Hollywood v. Superior Court, 2018 Cal. App. LEXIS 190 (Cal. App. Ct. Mar. 8, 2018), but that is what the case is about. Plaintiff voluntarily checked himself in to a rehabilitation facility and then proceeded to smuggle in heroin and overdose. Id. at *2-3. He then brought a negligence action against the rehab facility alleging it failed to take reasonable steps to make sure residents could not get illegal drugs. Id. at *3-4. So the question is whether plaintiff’s own misconduct bars his right to recovery in tort for his injuries – in pari delicto or “wrongful conduct” rule. The case also discusses whether the claim is barred on statutory grounds.

The court examined defendant’s statutory defense first. The statute at issue is the Drug Dealer Liability Act (DDLA) which is based on the Model Drug Dealers Liability Act which has been adopted in some version in more than 20 states. Id. at *8. The primary goal of the DDLA is to provide a civil remedy for damages to those who are injured as the result of someone else’s use of illegal drugs – parents, employers, insurers. Id. at *9. Such parties are entitled to both economic and non-economic damages and can recover from both the person who actually sold the illegal drugs to the user and anyone “who knowingly participated in the marketing of illegal controlled substances.” Id. at *12. In other words, the DDLA imposes a broad market share liability “in order to deter drug traffickers with potentially high civil damages awards.” Id. at *11.

The DDLA also allows an illegal drug user to bring a more limited claim, if certain conditions regarding cooperation with law enforcement and non-use of illegal drugs are met. The claim can be brought only against the direct supplier/manufacturer/importer of the actual drugs used and only economic damages can be recovered. Id. at *12-13. The DDLA goes on to state: “An individual user of an illegal controlled substance may not bring an action for damages caused by the use of an illegal controlled substance, except as otherwise provided in this section.” Id. at *13. In Hollywood, the rehab facility argued that that sentence precluded plaintiff from bringing his negligence claim against it as it was not the supplier of the drugs that caused his injury. Now all of this should sound like preemption to our DDL blog readers, but because we are talking about co-equal state law (state statute and state common law), the question is framed as whether the enactment of the statute displaced the existing common law. Id. at *8n.7. And yes, California’s general rule is a presumption against displacement. Id. at *15-16.

First, in construing the sentence limiting the claims a drug user can bring, the court noted that the DDLA defines “individual user” as “the individual whose use of a specified illegal controlled substance is the basis for an action under this division.” Id. at *15. Therefore, the DDLA did not need to repeat “under this division” when talking about the claims an individual user could bring because it was already limited by definition to claims under the act. Id. Second, the court found no legislative intent to “supplant common law” as to the circumstances of when a drug user could pursue claims against a third-party. Since the primary goal of the DDLA was to expand the class of potentially liable parties, the court was unwilling to interpret the act to restrict or bar other common law remedies.

Application of that common law to plaintiff’s claim, however, found it was lacking any legal support. In its analysis of the “wrongful conduct” doctrine, the court examined the development of the law in relation to liability for furnishing alcohol. After some back and forth in the courts, the California legislature enacted a statute to limit the liability of those who serve alcohol finding the consumption of alcohol should be the proximate cause of injuries to the intoxicated person or injuries caused be the intoxicated person, with exceptions for serving minors. Id. at *19-21. Similar laws exist protecting hosts who furnish alcohol. Id. at *22. Some plaintiffs have argued that because these laws confer immunity on those who serve/furnish alcohol, “persons less directly responsible for the intoxicated state of another may be liable under nonstatutory theories.” Id. We had to quote it because we couldn’t think of another way to state such a ridiculous concept. Fortunately, California courts have found it just as ridiculous. In this case, the court concluded that the rehab facility took reasonable steps such as a search upon arrival and periodic room checks to prevent residents from using illegal drugs. It was not required to take extraordinary measures. Such a claim is not supported under the law, nor would public policy favor burdening the very facilities who are trying to help addicts with potential liability for “their residents’ foreseeable but unpreventable predilection to obtain and ingest drugs.” Id. at *28.

The Hollywood court could not find a single case “suggesting that liability could be predicated on the mere failure to undertake affirmative efforts to stop the user from ingesting drugs.” Id. at *25. In other words, there is no viable “general failure to thwart drug use” claim.  Id.  The same logic should apply to claims against manufacturers of prescription opioid drugs for failure to monitor distributors and retail sellers.

Several decisions since the beginning of the year, and two appellate rulings in the last couple of weeks, highlight another aspect of Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), that should be valuable to defendants.  BMS – which dealt with what the Court called “case-linked” (also known as “specific”) personal jurisdiction, had some choice things to say about what kind of forum-related contacts suffice to confer jurisdiction.

Under BMS, case-linked jurisdiction “must “arise out of or relate to the defendant’s contacts with the forum.”  Id. at 1780 (internal quotes omitted) (emphasis original).  Where the “relevant conduct occurred entirely” out of state, “the mere fact that this conduct affected plaintiffs with connections to the forum state did not suffice to authorize jurisdiction.”  Id. (internal quotes omitted) (emphasis original).  Without a plaintiff/case-specific factual hook, “specific jurisdiction is lacking regardless of the extent of a defendant’s unconnected activities in the State.”  Id.

Finally, the BMS court reiterated that a defendant’s distributing a product through independent third parties doesn’t create case-linked jurisdiction either.

A defendant’s relationship with a third party, standing alone, is an insufficient basis for jurisdiction.  In this case, it is not alleged that [defendant] engaged in relevant acts together with [its distributor] in [the forum]. . . .  The bare fact that [the defendant] contracted with a [forum] distributor is not enough to establish personal jurisdiction in the State.

Id. at 1783 (various citations and quotation marks omitted).  BMS also cited (many times) and followed World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286 (1980), which BMS described as holding that an “isolated occurrence” is not capable of supporting jurisdiction where “the defendant carried on no activity” in the state “whatsoever” and one of its products, in a “fortuitous circumstance,” caused injury when it “happened to suffer an accident while passing through” the state.  BMS, 137 S. Ct. at 1782.

And, of course, as we’ve mentioned before, there is also the federalism aspect of BMS:

[T]he primary concern is the burden on the defendant. . . .  [E]ven if the defendant would suffer minimal or no inconvenience from being forced to litigate before the tribunals of another State; even if the forum State has a strong interest in applying its law to the controversy; even if the forum State is the most convenient location for litigation, the Due Process Clause, acting as an instrument of interstate federalism, may sometimes act to divest the State of its power to render a valid judgment.

Id. at 1780-81 (several internal quotation marks from World-Wide Volkswagen omitted).

The discussion in BMS – particularly given that it was authored by Justice Alito – suggested to us that so-called “stream of commerce” (“SoC”) jurisdiction is also likely on its way out.  SoC jurisdiction, for those of you who don’t live with this stuff day in and day out, doesn’t involve litigation tourists.  Rather, it is s theory that plaintiffs advance when they claim to be injured in the forum by the product of a defendant that has nothing to do with that forum, except that in Tinker to Evers to Chance to Steinfeldt to Kling to Sheckard to Slagle to Schulte fashion, its product wound up in the state due to the independent actions of others.  The product causing harm in the jurisdiction, without more, is purportedly enough to create case-linked personal jurisdiction under this theory.  The defendant need not have intended, or even be aware, that its products were present in the forum state.

As we discussed here, in connection with the last time the United States Supreme Court addressed this variant of case-linked jurisdiction directly, SoC jurisdiction, particularly in its more extreme forms, does not depend the defendant having deliberately acted to market its products in the forum state.  Instead “stream of commerce” is just what it sounds like.  The only connection between the defendant and the jurisdiction is happenstance, in that random acts of intermediate product distributors-owners-sellers-whoever happened that brought the particular injury-causing product into the jurisdiction.

SoC jurisdiction has never commanded a majority on the Supreme Court. The best it ever did was four justices in Asahi Metal Industry Co. v. Superior Court, 480 U.S. 102 (1987), which not surprisingly arose from California.  In Asahi, Justice Brennan, speaking for four justices, stated:

As long as a participant in this process is aware that the final product is being marketed in the forum State, the possibility of a lawsuit there cannot come as a surprise.  Nor will the litigation present a burden for which there is no corresponding benefit.  A defendant who has placed goods in the stream of commerce benefits economically from the retail sale of the final product in the forum State, and indirectly benefits from the State’s laws that regulate and facilitate commercial activity.  These benefits accrue regardless of whether that participant directly conducts business in the forum State, or engages in additional conduct directed toward that State.

480 U.S. at 117.  This passage was dictum (no jurisdiction existed on the facts of Asahi) in a concurring opinion, but the concept of SoC jurisdiction in the absence of any forum-directed conduct by the defendant has persisted for decades.

In 2011, the Supreme Court held that SoC jurisdiction could not be asserted as a form of general jurisdiction in Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 929 (2011).  However, due to a concurring opinion by Justice Alito, the Court was unable to administer the coup de grâce in J. McIntyre Machinery, Ltd. v. Nicastro, 564 U.S. 873 (2011).  Four justices “conclu[ded] that the authority to subject a defendant to judgment depends on purposeful availment,” thus rejecting “the undesirable consequences of Justice Brennan’s approach” in Asahi.  Id. at 885.  This Nicastro plurality held:  (1) “jurisdiction is in the first instance a question of authority rather than fairness”; (2) “personal jurisdiction requires a forum-by-forum, or sovereign-by-sovereign, analysis”; and (3) “a defendant may in principle be subject to the jurisdiction of the courts of the United States but not of any particular State.”  Id. at 883-84.

However, Justice Alito, joined by Justice Breyer, refused “to announce a rule of broad applicability” that would have consigned SoC jurisdiction to the dustbin of history.  Id. at 887.  Instead, they agreed only that “a single sale of a product in a State does not constitute an adequate basis for asserting jurisdiction over an out-of-state defendant, even if that defendant places his goods in the stream of commerce, fully aware (and hoping) that such a sale will take place.”  Id. at 888-89.

We’ve thought, ever since BMS, that Justice Alito’s enunciation (discussed above), of the federalist model of jurisdiction in BMS should be the deathblow to the kind of SoC jurisdiction without purposeful availment that has bedeviled product liability defendants for decades.  He’s now on-board with what he wasn’t willing to join in Nicastro.  But our thoughts and a dime will get us a cup of coffee.  Now, however, several recent post-BMS decisions suggest that we’re right.

First, the Oklahoma Supreme Court the other day decided Montgomery v. Airbus Helicopters, Inc., ___ P.3d ___, 2018 WL 1164671 (Okla. March 6, 2018), and held that BMS eliminated the remaining jurisdictional underpinnings of SoC jurisdiction.  “[S]ubsequent, to [BMS] we must conclude that any ‘stream of commerce’ test applied to [defendants’] products . . . cannot establish Oklahoma jurisdiction”:

[BMS] requires an affiliation between the forum and the underlying controversy, an activity or an occurrence that takes place in the forum State, which subjects the cause to the State’s regulation.  The adjudication of issues must derive from, or be connected with, the very controversy that establishes jurisdiction.  Accordingly, a “sliding scale” approach, or “totality of the contacts” or “stream of commerce” approach is insufficient to establish specific personal jurisdiction.

Id. 2018 WL 1164671, at *9.  While Oklahoma had “an interest in adjudicating this case,” since “most of the harm” occurred there, “these facts alone, without [defendants] having further direct and specific conduct with this State directly related to the incident giving rise to the injuries, is insufficient for asserting specific personal jurisdiction over them” after BMS.  Id. at *10.  Montgomery thus wipes out a pro-plaintiff decision on SoC jurisdiction handed down within weeks of BMS.  See Tarver v. Ford Motor Co., 2017 WL 3527710 (W.D. Okla. Aug. 16, 2017).

Second, as discussed last week, Shuker v. Smith & Nephew, PLC, ___ F.3d ___, 2018 WL 1096185 (3d Cir. March 1, 2018), disposed of a SoC–based jurisdiction claim against the target defendant’s parent.  The Third Circuit had for decades avoided taking a position on Asahi-style SoC jurisdiction, neither adopting nor definitively rejecting it.  See, e.g., D’Jamoos v. Pilatus Aircraft Ltd., 566 F.3d 94, 105-06 (3d Cir. 2009) (avoiding SoC issue by holding that airplane crashing in state did not “enter” the stream of commerce “as that term is generally understood”).  But, with BMS on the books, the court flatly rejected SoC jurisdiction in Shuker.  “We perceive no merit in [plaintiffs’] stream-of-commerce theory of personal jurisdiction.”  2018 WL 1096185, at *14.  Observing that “[a] plurality of Supreme Court Justices has twice rejected the stream-of-commerce theory,” Shuker took notice of (as did we) of the relevant language in BMS:

Indeed, the Supreme Court has recently held that “[t]he bare fact that [a non-resident defendant] contracted with a [resident] distributor is not enough to establish personal jurisdiction in the State.”  [citing BMS]  We thus have no cause to revisit our Court’s precedent on this issue, and we decline to adopt [plaintiffs’] stream-of-commerce theory of specific personal jurisdiction.

2018 WL 1096185, at *14 (affirming rejection of SoC jurisdiction without any discovery).  The Third Circuit’s precedential rejection of broad SoC jurisdiction in Shuker calls into question some backward-looking district court decisions that we came across in writing this post, those being Antonini v. Ford Motor Co., 2017 WL 3633287 (M.D. Pa. Aug. 23, 2017), and Lindsley v. American Honda Motor Co., Inc., 2017 WL 3217140 (E.D. Pa. July 28, 2017).

Third, Venuti v. Continental Motors, Inc., ___ P.3d ___, 2018 WL 312532 (Utah App. Jan. 5, 2018), similarly rejected SoC jurisdiction in another plane crash case.  Beyond selling the product generally, “there [wa]s no evidence that [defendant] took any additional steps to target [the forum state] for the sale of the product.”  Id. at *4.  “[A] series of third-party sales” rather than “any deliberate action on the part of” the defendant brought the product into the state.  Id. at *5.  “[M]erely placing a product into the stream of commerce knowing that it could be swept into the forum state does not subject a manufacturer to personal jurisdiction.”  Id.  Without some “target[ing]” of the forum, that the defendant sold a lot of products generally doesn’t create jurisdiction, particularly after BMS:

When there is no connection between the forum and the underlying controversy, “specific jurisdiction is lacking regardless of the extent of a defendant’s unconnected activities in the State.”

Id. at *6 (quoting BMS, 1347 S. Ct. at 1781).

Fourth, also in 2018, Moseley v. Suzuki Motor, Inc., 2018 WL 539330 (D. Idaho Jan. 24, 2018), reached the same conclusion.  The plaintiff in Moseley asserted SoC jurisdiction over a foreign product manufacturer without even bothering to allege how the product, which had been sold by a now-defunct independent distributor in Utah in 2008, made its way to Idaho by 2015, where it was involved in a fatal accident.  Id. at *1; see id. at *2 (“Plaintiffs have failed to explain how the motorcycle even ended up in Idaho”).

In the absence of any evidence that the defendant manufacturer ever “specifically targeted” the forum state, id. at *2, the Moseley court rejected SoC jurisdiction.  Where “only the distributor, but not the manufacturer, purposefully availed itself of the benefits of doing business” in a state, personal jurisdiction over the manufacturer does not exist, even if the distributor, in this particular case, was a corporate subsidiary of the defendant.  Id. at *3.

Courts are thus starting to get it.  While BMS was not a SoC jurisdiction case, it did authoritatively delineate the standards for case-linked personal jurisdiction, which under Goodyear is the only possible basis for SoC jurisdiction.  The holding in BMS that merely having in-state distributors is not enough for case-linked jurisdiction should therefore be fatal to non-purposeful availment versions of SoC jurisdiction, which rest on “contacts” (if they can even be called that) that are less significant..  In that respect, it should not matter that – unlike BMS – the plaintiffs in SoC jurisdiction cases are not litigation tourists, but rather resident plaintiffs.  If, and only if, “purposeful availment” rather than the “fortuitous” conduct of third persons brought the product into the jurisdiction, can there be personal jurisdiction under any sort of SoC jurisdiction theory after BMS – as courts now appear to be recognizing.