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JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at  His LiinkedIn page is here.

As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws that branded drug manufacturers could not be liable for injuries suffered by plaintiffs who never used their products, but only took competing generic drugs.  Twenty-something states in one opinion.  If that had ever happened before, we remain unaware of it.

Well, it recently happened again, albeit on a smaller scale. See In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2017 WL 3448548 (D. Mass. Aug. 4, 2017).  The Zofran MDL is like Darvon in that it involves a relatively old drug, approved back in 1991, for prevention of nausea and vomiting in cancer patients undergoing difficult treatments such as chemotherapy. Id. at *1.  Since Bendectin was driven off the market by bogus birth defect litigation, drug companies have been loathe to pursue anything for treating morning sickness (we know of only one), which leaves off-label use.  Id. at *2.  Thus, Zofran and its generic equivalents are frequently used off-label by women (and their physicians) seeking some kind of relief from pregnancy-related morning sickness.

The Zofran litigation is a consequence of this off-label use – anything used during pregnancy becomes the target of birth defect lawsuits.  Plaintiffs make a rather extreme claim, that defendants should be liable for not researching the risks of off-label uses for which they never sought FDA labeling approval.  Id. at *3 (“The crux of all of the claims is that defendants failed to perform an adequate study of the safety of ingesting Zofran during pregnancy”).

When generic drugs get involved, things get even worse. Plaintiffs using generic drugs are barred by preemption from suing those manufacturers (absent unusual situations like failure to update warnings with FDA-ordered changes), id. at *4, but they still want money, so they try to sue the branded manufacturers – innovator liability, in these cases for off-label uses.  Such claims seek to hold manufacturers liable for the risks of someone else’s product used in a manner for which that product was never labeled.

In Zofran, the court was having none of it.  It ordered all generic plaintiffs – 35 plaintiffs from 19 states − alleging innovator liability to justify those allegations.  Id.  Challenged to put up or shut up, most of the generic plaintiffs dropped out, leaving six plaintiffs suing under the laws of six states, those being Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma. Id.

Examining the laws of those six states, the court in Zofran, like the court in Darvocet, concluded that none of them would take the radical step of holding branded drug manufacturers liable for injuries caused by competing generic drugs.  Such liability ran contrary to “the long-settled principle that a manufacturer of a product cannot be held liable for injuries caused by another company’s product.”  Id. at *4.  Instead, plaintiffs alleged that:

As the holders of the New Drug Application (NDA) for Zofran and the patents for Zofran, [innovator] Defendants knew that any generic drug manufacturer would be required by law to use the same labeling as Zofran’s, and that any inadequacies in the labeling of generic ondansetron could be corrected by Defendants only.

Id. at *5.  Thus, the innovator defendants were being held liable not for what they chose to do, but rather for what was “required by law” – how Congress, in amending the FDCA, had chosen to structure the generic drug market.  While plaintiffs claimed this was not “novel,” id., to paraphrase Yogi Berra, “half the lies they tell about [the law] aren’t true.”

The overwhelming majority of courts—including all seven federal circuits to have addressed the issue—have held that the manufacturer of a brand-name drug may not be held liable for injuries caused by ingestion its generic equivalent, regardless of the theory of liability.

Id. at *6 (citations omitted).  The omitted citations, of just the federal appellate decisions, take up half a page of the opinion.  But don’t fret about that.  Our “Innovator Liability at 100” post, which discusses all these decisions, is closing in on 14,000 words.  The precedent rejecting innovator liability is truly “overwhelming.”

The “minority view,” on the other hand, consists of exactly four cases, one of which was “superseded by statute” “within a year” of being decided.  Id. at *8-9 & n. 6.  As for the relevant states in Zofran:

Georgia:  An intermediate state appellate court, the Sixth Circuit in Darvocet, and a federal district court, have all rejected innovator liability.  See PLIVA, Inc. v. Dement, 780 S.E.2d 735, 743 (Ga. App. 2015); Darvocet, 756 F.3d at 943; Swicegood v. Pliva, Inc., 543 F. Supp. 2d 1351, 1353-54 (N.D. Ga. 2008). Zofran, 2017 WL 3448548, at *8-9.  On the other side – zilch.  Actually, Georgia precedent rejecting innovator liability is more extensive than what was mentioned in Zofran.  See our “at 100” post for details.

Indiana:  The Sixth Circuit Darvocet case also rejected innovator liability under Indiana law.  756 F.3d at 845. Zofran, 2017 WL 3448548, at *10-11.  Again, there are several more Indiana law cases also rejecting innovator liability that aren’t mentioned in Zofran – but are in our post.

Kentucky:  Not only is Darvocet again on point, but the Sixth Circuit likewise rejected innovator liability in another Kentucky law case.  Darvocet, 756 F.3d at 945-46; Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. 2011).  Zofran, 2017 WL 3448548, at *11.  As our post adds, a couple of Kentucky litigation tourists also got kicked out of court in Missouri on innovator liability grounds.

Massachusetts:  Two Massachusetts trial courts have rejected innovator liability. Rafferty v. Merck & Co., 2016 WL 3064255, at *4-5 (Mass. Super. May 23, 2016); Kelly v. Wyeth-Ayerst Laboratories Co., 2005 WL 4056740, at *2-5 (Mass. Super. May 6, 2005).  Zofran, 2017 WL 3448548, at *12-13.  We provide some more on-point Massachusetts precedent in our post, which never has to cite to a non-Westlaw slip opinion, because Bexis gets all the good ones added.

New York:  Darvocet, again, plus federal and state trial court decisions, all rejecting innovator liability under New York law.  Darvocet, 756 F.3d at 949; Goldych v. Eli Lilly & Co., 2006 WL 2038436, at *3-8 (N.D.N.Y. July 19, 2006); Weese v. Pfizer, Inc., 2013 WL 5691993, at *2 (N.Y. Sup. Oct. 8, 2013).  Zofran, 2017 WL 3448548, at *13-14.  Actually, there’s another recent federal district court decision that agrees, as our post discusses.

Oklahoma:  Not only Darvocet, but another federal appellate decision both reject innovator liability under Oklahoma law. Darvocet, 756 F.3d at 950-51; Schrock v. Wyeth, Inc., 727 F.3d 1273, 1281-84 (10th Cir. 2013).  Zofran, 2017 WL 3448548, at *14.  Our post adds another state trial court opinion applying Oklahoma law in a similar manner (a toughie, but we found it).

Thus, the Zofran decision concludes, as to the merits of innovator liability, that there aren’t any merits, and that contorting state law to impose liability for liability’s sake, without any basis in precedent or policy, isn’t a good idea:

In summary, none of the state supreme courts in any of the six relevant states have ruled on precisely the issues presented here.  Nonetheless, for each of the jurisdictions, there is case law suggesting, often strongly so, that dismissal is appropriate. . . .

It is true that dismissal would appear to leave consumers injured by generic drugs without any form of remedy.  But it is by no means obvious that the minority viewpoint is correct or fair, or even that it is the outcome that best protects consumers.  Just as it may be unfair to leave some injured consumers without a remedy, so too it may be unfair or unwise to require brand-name manufacturers to bear 100% of the liability, when they may have only 10%, or less, of the relevant market.

Id., 2017 WL 3448548, at *14 (citations omitted).

Finally, Zofran rejects what appears to be the new overall strategy of generic plaintiffs peddling innovator liability theories – try to shift the battle from federal to state courts.  Zofran refused to certify the issue to the high courts of the six states in question.  Id. at *15-17.  New York doesn’t even allow certification (an “oops” for plaintiffs).  Id. at *16.  “Clear and recent” appellate authority in every state but Massachusetts, leaves little doubt what the relevant law is.  Id.  As for Massachusetts (and indeed all the states), the question proposed to be certified “involve[d] alleged misrepresentations, none of which are identified by the plaintiff,” leaving the basis for those claims “unclear.”  Id. at *17.  Certification of such a “hypothetical” question would thus be “inadvisable”:

It is therefore entirely possible that the Court could wind up certifying a purely hypothetical question that has no actual relationship to the evidence.  It would be an enormous waste of judicial resources to certify a fact-bound question to the [state high court], only to find that the facts as ultimately proved are different. . . .  Any answer . . . to the proposed question might therefore prove to be entirely advisory.

Id. (footnote omitted).  Courts faced with innovator-liability-related certification requests in the future are likely to be facing similar situations, given how loosely our opponents throw around misrepresentation allegations.  Kudos to Zofran for not taking the easy way out, and declining to kick the decisional can down the road.

Today’s guest post is by long-time friend-of-the-blog, Dick Dean, of Tucker Ellis.  This post covers the preemption aspects of the recent (after remand from the Third Circuit) aviation decision in Sikkelee v. Avco.  If you’re interested in this issue, we heartily commend the actual decision (which, we warn you, is quite lengthy), since in addition to its many significant legal rulings, it is studded with pungent language, mostly calling out and rejecting plaintiff’s many off-the-wall arguments.  As always our guest poster deserves all the credit (and any blame) for the discussion that follows.


At times one can tell from the very first paragraph of an opinion that what follows will be an interesting read.  Such is the case with Sikkelee v. Avco Corp., Case. No. 4:07-CV-00886, 2017 WL 3317545(M.D. Pa. Aug. 3, 2017), a case involving the death of a pilot during a crash at take-off:

A weightless innocence so often attends our daydreams of flight. As the American aviator John Gillespie Magee, Jr., loftily described it, pilots “dance [ ] the skies on laughter-silvered wings,” soaring “high in the sunlit silence.”   Sadly, it would seem that Magee’s “high untrespassed sanctity of space” must belong to a universe far away from the dark origins and convoluted history of this case.

Id. at *1. From this ephemeral beginning, we are soon transported to the detailed world of federal aviation regulations and their interaction with design defect and implied preemption.

This case is indeed “convoluted.”  The crash occurred in 2005, and suit was filed in 2007, alleging different legal theories that distill to claims of a poorly designed carburetor.  There were two district court decisions (by two different district judges) dismissing plaintiff’s state law torts claims on grounds of field preemption before the case reached the Third Circuit in 2015.  Field preemption occurs where the subject matter of the law suit is so occupied by the federal government that there is no room for state activity.  It is rarely invoked and hardly ever found. [ed. note: we know of only one FDCA field preemption decision]  The factual underpinnings of field preemption in the aviation field was best summarized in a concurring opinion of Justice Jackson in a tax dispute, quoted by the Sikkelee Court in its recent decision:

As the late Honorable Robert H. Jackson, Associate Justice of the Supreme Court, once remarked, “Planes do not wander about in the sky like vagrant clouds.  They move only by federal permission, subject to federal inspection, in the hands of federally certified personnel and under an intricate system of federal commands.”  Northwest Airlines v. State of Minnesota, 322 U.S. 292, 303 (1944).  Justice Jackson’s observation sprang from “the national responsibility for regulating air commerce” and reinforced the notion that the “air is too precious as an open highway to permit it to be owned” by local interests.  Id.  “Local exactions and barriers to free transit in the air would neutralize its indifference to space and its conquest of time.”  Id.

Id. at *2.

Relying on the breadth of the Third Circuit’s decision in Abdullah v. American Airlines, 181 F.3d 363 (3d Cir. 1999) (holding that federal law preempts the field of aviation safety in the context of federal in-flight seat belt regulations versus state law negligence claims), the Sikkelee Court found preemption first at 731 F. Supp.2d 429 (M.D. Pa. 2010) and most recently at 45 F. Supp. 3d 431 (M.D. Pa. 2014).  The Third Circuit reversed the later decision, finding that state law design claims were not covered by the decision in AbdullahSikkelee v. Precision Automotive Corp., 822 F.3d 680 (3d Cir. 2016).  But it is also observed that the claims might be barred by implied preemption—noting that the design changes advanced by plaintiff necessarily might have required FAA approval and thus would be barred under Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, —U.S.—-, 133 S.Ct. 2466 (2013).  Indeed, it cited Mensing noting that where a party cannot “independently do under federal law what state law requires of it,” the state law claim is preempted.  822 F.3d at 703.  It remanded for consideration of that issue. (See DDLaw April 22, 2016 post discussing the Third Circuit’s suggestion that this claim might be conflict preempted).

On remand, the district court first examined the relevant FAA regulations noting “the FAA has littered the books with a maze of regulations not readily traversed by most laypersons.”  2017 WL 3317545 at *2.  It observed that the first step in production of a new aircraft or aircraft engine is a “type certificate” confirming that the aircraft or its component is properly designed and manufactured.  Id. at *3.  It is an “onerous process requiring numerous submissions that precisely detail the specifications.”  Id.  A type certificate holder may not independently change a type certificate’s design details without first obtaining FAA approval.  Id. at *5-*6 (citing 14 C.F.R. §21.31).  The district court observed that the relevant test was whether federal regulations prevented the defendant from unilaterally doing what state law required, citing the Mensing test of independent action.  The court found that the alternate design theory advocated by plaintiff would have required approval by the FAA and was therefore conflict preempted.  It specifically cited the key language from Mensing establishing that the mere fact that defendant could have asked the agency to change its rules does not defeat preemption.

“To decide these cases,” the PLIVA Court concluded, “it is enough to hold that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.”  Id. at 623–24.  Justice Thomas then noted that in regulatory preemption cases such as these, “the possibility of possibility”—that is, the possibility that the agency will approve a requested change—does not defeat conflict preemption.  Id. at 624.

2017 WL 3317545 at *24. More colloquially, if you have to ask, it is preempted.

The Sikkelee Court also made two other points familiar to the readers of this blog.  First, it noted that impossibility conflict preemption may be found even in the absence of express preemption.  Id. at *22.  Second, it recognized that impossibility preemption requires no inquiry into congressional intent.  Id.  The only question is whether there is a conflict between state and federal law.

When Mensing was decided, the first argument of the plaintiffs’ bar (and one that is still run today) was that it was limited to generics.  That was clearly wrong based on the “any party” language of Mensing.  Cases like Yates v. Ortho-McNeil-Janssen Pharmaceutical, Inc., 808 F.3d 281 (6th Cir. 2015) and In re Celexa and Lexapro Marketing and Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), and many others [ed. note: see our preemption cheat sheet for the citations] have expanded the Mensing test to brand drug manufacturers’ where regulatory approval was a predicate of the claim alleged.  Now the Mensing test has been appropriately applied to the federal aviation context.  With this decision, it can be said that Mensing applies generally—not just to generic drugs, or even just drugs at all.  In Mensing and Bartlett, “[c]onflict preemption did not turn on a drug maker’s status as a brand-name or generic manufacturer per se.”  Sikkelee, 2017 WL 3317545 at *31 n.26.  That is not a surprising conclusion, since this is how implied preemption is supposed to work, but it is nice to have this solid opinion building upon the Third Circuit’s observations actually finding implied preemption in the aviation context.  Going forward, one needs to read any complaint involving relevant federal regulations with an eye on preemption: if the relief sought could not be undertaken unilaterally by the defendant in light of federal law or regulations the claim is preempted.

[Ed. note: we’d like to add one final point – about proximate cause. Sikkelee also recognized something we’ve observed about design changes too “minor” to require FDA pre-approval:  that such changes can’t be causal in a product liability action. The same is true of “minor” design changes under the FAA:

If the alleged omission was a minor one, then by definition, it had no effect on the aircraft engine’s structural strength, reliability, operational characteristics, or airworthiness. . . .  [T]he underlying claims are nothing more than state law tort actions, which require proximate causation.  If the alleged breach of duty had no appreciable effect on the engine’s reliability, airworthiness, structure, or operation, then proximate cause cannot be met.

2017 WL 3317545 at *28 . Likewise, design changes too “minor” to affect a product’s safety and effectiveness (the corresponding FDA standard), could not possibly be causal in a product liability action.]



Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism – allegedly causes some male users to develop abnormal breast tissue growth. Particularly when compared to the consequences of the conditions Risperdal is indicated to treat, that seems like a relatively minor risk.  It isn’t fatal.  It isn’t a long-term disability.  It doesn’t prevent one from making a living.  Thus, Risperdal litigation is a prime example of low-value cases that only exist because of the mass-tort system that has saddled the country for so long.

Thus, it is hardly surprising that Risperdal cases are on the front lines of the battle to rein in our long national mass-tort nightmare.

Just last week we learned of these two decisions:

(1) Covington v. Janssen Pharmaceuticals, Inc., 2017 WL 3433611 (E.D. Mo. Aug. 10, 2017).  Covington was one of the ridiculously misjoined multi-plaintiff complaints that mashed together residents from all over the country.  Before Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), Missouri federal courts routinely remanded these atrocities to the St. Louis litigation cesspool because there was always at least one diversity-destroying non-Missouri plaintiff, as well as one jurisdiction establishing Missouri plaintiff in the bunch.  Covington, 2017 WL 3433611, at *2 (“Historically − and especially in this district − courts generally have addressed subject matter jurisdiction first”).

Not anymore.

Covington is typical of the multi-plaintiff complaint genre – 54 plaintiffs from 26 different states.  2017 WL 3433611, at *1.  “Only one plaintiff” alleged injury from use of the drug “in the state of Missouri.  Id.  As for the rest:

The Non-Missouri plaintiffs, or those who do not have any connection to the state of Missouri, do not allege that they were prescribed Risperdal or any of its variants in Missouri, ingested the same in Missouri, or were injured in Missouri.


With BMS, the personal jurisdiction issues involving litigation tourism of this sort were largely resolved.  With no fixed “jurisdiction hierarchy,” it was now logical to take up this “more straightforward issue first. ” Id. at *2.

However, these [contrary] cases were decided before [BMS] and State ex rel. Norfolk S. Ry. Co. v. Dolan, 512 S.W.3d 41 (Mo. 2017) (en banc) [our post on Dolan is here].  These decisions make the personal jurisdiction issue in this case much easier to decide. . . .  Further, analyzing the challenge to personal jurisdiction first avoids any issues relating to fraudulent joinder.  Personal jurisdiction is now the more straightforward inquiry and should be addressed first as it is in the interests of judicial economy and expeditiousness.

Id. (citations and quotation marks omitted).

The personal jurisdiction question was easy.  There could be no general jurisdiction.  “[N]o defendant is incorporated in Missouri nor has its principal place of business in Missouri.”  Id. at *4.  ‘Nuff said.  Nor was there specific personal jurisdiction for all but one of the plaintiffs – thus removing the planted plaintiffs from the defendants’ home states.

[B]esides the Missouri plaintiff, no other plaintiff allege that they, or a child or incapacitated person whom they represent as next friend, were prescribed or purchased Risperdal in this state, suffered an injury from Risperdal in this state, or received treatment for an injury from Risperdal in this state.

Id.  The “mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug in Missouri] − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.”  Id. at *4 (quoting BMS).  Thus 53 of the 54 plaintiffs were dismissed (without prejudice, and with the laws of their home states determining whether an unsuccessful litigation tourism jaunt tolled their statutes of limitations).  A single plaintiff’s low-value case thus remained in Missouri federal court.  Id. at *5.  It probably won’t last long, since the March 8, 2017 filing date was more than a dozen years after 2004, when that plaintiff admits discovering the supposed injury.  Id. at *6.

Plaintiffs mounted unsuccessful rearguard actions in Covington.  They sought a stay – claiming “prejudice” from the need to sort out a supposed jurisdictional morass that they, themselves, created.  That went nowhere.  Id. at *3 (“A motion to stay should not be abused by a party to dictate which motion is first addressed by the Court.”).  They also sought “jurisdictional discovery” – a fishing expedition to search for Risperdal/Missouri contacts.  Covington likewise saw that request for what it was:

Here, the plaintiffs do not plead any specific facts that support their contention that this Court has personal jurisdiction over all of the plaintiffs’ claims. Alleging that facts might be discovered during a jurisdictional discovery expedition will not allow plaintiffs to survive a 12(b)(2) motion to dismiss.

Id. at *5.

Summing up, Covington observed:

Unfortunately for the plaintiffs, [BMS], under the facts of this case, made personal jurisdiction the more straightforward issue and therefore more proper to be analyzed first.  Further, [BMS] held that forums, like Missouri in this action, do not have specific personal jurisdiction over non-resident corporations when the plaintiffs do not allege any specific connection between the forum and the specific claims at issue.

Neither this Court nor the state court in which this action was removed can exercise personal jurisdiction − whether general or specific − over the defendants for the claims brought by the 53 non-Missouri plaintiffs.

Id. at *6.

That’s one.

(2) West v. Janssen Pharmaceuticals, Inc., 2017 U.S. Dist. Lexis 124276 (Mag. M.D. Ala. Aug. 4, 2017).  West is something of the obverse of Covington.  In Covington the plaintiffs joined together in an attempt to manufacture jurisdiction for a horde of weak cases, whereas in West, jurisdiction already existed, so the plaintiffs were trying to join their weak cases together to prejudice the defendant at trial.  Once again, the court wasn’t buying the consolidation.  West involved two plaintiffs, Harper and West, treated at one point by the same prescribing physician, both alleging the same injury from the same drug.  Id. at *2, 11.

But that was as far as the similarities went.

The two plaintiffs were of much different ages; one a minor, the other not. One involved off-label use; the other not.  One involved innovator liability (being filed during the few Weeks window when that theory was allowed in Alabama); the other not.  There were various other differences as well, such as duration of use, and when the drug was prescribed (affecting the relevant warnings), and the age at which the risk allegedly manifested.  Id. at *13-15.

The dissimilarities in the Plaintiffs’ claims have be-come more apparent as discovery and expert testimony have developed.  Harper began taking Risperdal as a five or six-year old and was always a minor while taking the medication.  In contrast, West did not begin taking the medication until he was almost eighteen years old and was physiologically an adult.  The significance of this difference is highlighted by the expert causation testimony. . . .  Further, the consequence of Risperdal not being approved for pediatric use takes on a much different meaning in the two cases.

Id. at *12-13.

These differences precluded a joint trial under Fed. R. Civ. P. 20.  “The critical differences between the claims asserted by Plaintiffs outweigh the similarities between the cases, and the court finds trying the cases together would thus be inefficient and confusing for both the Court and the jury.”  Id. at *14.  The presence of an innovator liability claim in one of the cases demonstrated their legal as well as factual disparity.  Id. at *15-16.  Further, “West and Harper were prescribed multiple prescriptions, written at different times by different physicians and in different doses at different physiological stages of their lives.”  Id. at *16.

Thus, two disparate plaintiffs could not claim injury “from the same series of transactions” as required by Rule 20. Id. at *17.  No consolidation synergies for these two weak cases.

*          *          *          *

Two Risperdal cases; two different jurisdictions; two attempts by plaintiffs to manipulate joinder to the disadvantage of defendants defeated.  We look forward to similar rulings in the future.



About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of Torts §402A, comment k (1965) was somehow limited to implantable – as opposed to non-implantable – medical devices.  While most medical device litigation has historically involved implants, in that post we saw nothing in comment k, or the broader concept that prescription-only products have inherent risks (why their availability requires a doctor’s prescription in the first pace), that is logically limited to implantable devices.

We pointed out in that post that this rather weird argument apparently originated in ill-considered dictum in Chandler v. Chiron Corp., 1997 WL 464827, at *4 (N.D. Cal. July 28, 1997), a case which ultimately dismissed the plaintiff’s design defect claim on causation grounds (and was affirmed on that basis, see 176 F.3d 481 (9th Cir. 1999)), and was directly refuted by controlling California appellate authority: Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), which applied the comment k unavoidably unsafe rationale to intraocular fluid, a non-implanted surgical aid.  As we put it then:

The issue is not whether the device is implanted, it is whether the device unavoidably poses risks even as it must be used by physicians to “save lives or reduce pain and suffering.”

Quoting Brown v. Superior Court, 751 P.2d 470, 479 (Cal. 1988)).

We were recently contacted by fellow defense counsel about a similar argument being made by plaintiffs in a Pennsylvania case, since Pennsylvania, like California, also applies comment k across the board.  We took a look at the case law and let them know that Pennsylvania precedent likewise has not recognized any artificial distinction between implanted and non-implanted prescription medical devices.  Rather, in Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 315 (E.D. Pa. 2016), a Pennsylvania court applied comment k/the unavoidably unsafe doctrine to bar strict a liability claims involving a prescription device that wasn’t an implant. Wagner involved a temporary feeding tube used while the plaintiff was in intensive care, and the court dismissed strict liability design and warning defect claims, but not manufacturing defect claims, under Pennsylvania’s broad reading of comment k.  225 F. Supp.2d at 315 & n.4.  Indeed, Wagner essentially took the application of the unavoidably unsafe doctrine to design and warning claims as a given, as 9/10 of the opinion was about whether or not strict liability manufacturing defect claims could survive (which is a different issue we addressed here).  Id. at 316-18.

Maybe a feeding tube, although not technically an implant, still seems “close enough,” since such tubes do extend inside the body, albeit quite temporarily.  OK, but there’s plenty of precedent out there about devices that don’t even temporarily penetrate the body.

In Racer v. Utterman, 629 S.W.2d 387 (Mo. App. 1981), the plaintiff was injured when “a disposable drape manufactured by defendant . . . caught on fire resulting in serious burns.”  Id. at 391.  “The purpose of the surgical drape is to provide a sterile field and to serve as a barrier to prevent bacteria from reaching the operation site.”  Id. at 391-92.  The appellate court affirmed application of comment k to this product:

Comment k to the Restatement recognizes that “unavoidably unsafe” products achieve protection despite their danger “when accompanied by proper directions and warning”. . . .  On the record before us we find the surgical drape here to be an “unavoidably unsafe” product.  It is a highly useful product which affords substantially increased protection against infection during surgical procedures.  Its water-repellant attributes increase these protections.  In the state of knowledge at the time of the injury no method of making the product fire-resistant was available which did not adversely affect its barrier against infection or create potential injury to the patient from allergy or disease.

Id. at 393.  The defendant still lost, but on warnings, id. at 395, not because comment k didn’t apply to the drape because it wasn’t implanted.

The Illinois Supreme Court applied comment k’s unavoidably unsafe rationale to therapeutic x-ray radiation equipment in Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980).

The possibility that in certain cases protection of human life and health might be diminished by the imposition of liability has been recognized in section 402A of the Restatement. Comment k indicates that certain products, though dangerous, are necessarily so and do not warrant the imposition of liability. . . .  [C]omment k presume[s] in their treatments that the denomination “product” has already been applied to the matter in question.  Nevertheless, imposition of strict liability is a question of policy, and often the same policy concerns are involved in discussions which are ostensibly diverse, for example: the meaning to be given such terms as “product,” “defective,” “unreasonably dangerous,” and “business of selling.”  For the reasons stated we conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments by a hospital.

Id. at 394-95 (citations and quotation from Prosser’s On Torts omitted).

Two other cases have applied comment k’s analysis to external patches that release drugs that are absorbed through the skin.  In Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997), the court cited and quoted comment k (“the law regarding such products appears at Comment k”) in a case involving nicotine patches.  These were products “incapable of being made safe, but are of benefit to the public dispute the risk.  Id. at 300.  Likewise, in Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012), a fentanyl “pain patch” was considered to be within the scope of comment k.  The court refused to grant summary judgment, but only because it found “genuine issues of material fact . . . as to whether the patches at issue were incapable of being made safe,” not because comment k was categorically inapplicable to non-implanted products.  Id. at *7.

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court applied comment k to a surgical robot – a piece of equipment that assists in the conduct of surgery and is never implanted in the body.  The court applied comment k analysis to the liability questions.  Id. at 526-28.  As in Racer, Taylor found that the comment k exception did not apply on the facts of the case, because it could not be said that the product warnings were adequate as a matter of law.  Id. at 528 (“[e]xemption from strict liability under comment k is expressly limited to products accompanied by adequate warnings”).  Once again, there was not a hint in Taylor that the fact that the robot was not an implant made comment k ipso facto inapplicable.  Washington law “safeguard[ed] the public to the greatest extent possible without discouraging the development and marketing of unavoidably unsafe products.”  Id.

The great majority of product liability litigation involving prescription medical devices happens to involve implants.  However, that descriptive fact is of no legal consequence to the applicability, or not, of the comment k/unavoidably unsafe product doctrine.  That doctrine is interpreted in a variety of different ways – most notably case-by-case versus across-the-board application to prescription medical products.  But no matter which way the doctrine is interpreted, its application is not dependent upon whether or not a medical device is implanted in the body.  At least three state high courts, two state intermediate appellate courts, and a couple of federal district court agree.  There is no contrary precedent, only the aforementioned dictum in Chandler, a 20-year-old district court case, the reasoning of which has never been adopted by any subsequent decision, and (as we already discussed) is refuted by the Cal. App. Armstrong decision.

We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers.  But while it’s illegal for anybody working for the U.S. government to accept anything of value from a “foreign state,” that doesn’t make it illegal, unethical, or even particularly noteworthy for a “learned intermediary” to accept things of value from prescription medical product manufacturers – provided, of course, that doing so doesn’t adversely affect patient care.

For example, the FDA knows and accepts that not only patients/subjects in clinical trials, but also physicians/investigators are routinely paid for their trouble. The FDA’s longstanding Guidance for Industry Financial Disclosure by Clinical Investigators does not require disclosure of “normal reimbursable expenditures” that compensate investigators for routine costs, as long as payments do not “exceed reasonable expectations.”  2001 WL 34768176, at *11.  Such expenses aren’t seen as having a “potential for bias.” Id. at *1.  Even interests that could potentially be a source of bias aren’t prohibited, or limited – they must only be disclosed:

  • Compensation the “value of which could be affected by study outcome.”
  • “A proprietary interest in the tested product”
  • An “equity interest in the [study] sponsor.”
  • “Any equity interest in a publicly held company that exceeds $50,000”
  • “Other sorts” of payments with “a cumulative monetary value of $25,000 or more made by the [study] sponsor.”

Id. at *1-2.

Thus, we don’t have much good to say about a couple of Texas district court opinions that would create an exception to the learned intermediary rule whenever the plaintiff’s prescriber has received any sort of compensation.  Not only is creating exceptions to state common-law rules none of a federal court’s business, but such a broad exception is contrary to precedent and totally unnecessary.

Anyway, the first of these cases was Murthy v. Abbott Laboratories, 847 F. Supp.2d 958 (S.D. Tex. 2011).  The plaintiff was a participant in the defendant’s clinical trial, and signed the standard informed consent documents to participate. Id. at 964.  Murthy refused to apply the learned intermediary rule, “first” because the defendant “arguably directly marketed” the drug to the plaintiff “by creating a promotional video,” and “second” because the prescriber – plaintiff’s doctor – “was compensated by [defendant].” Id. at 967.

Murthy then launched into an extended discussion of the “foundations” of the learned intermediary rule under Texas law.  Id. at 967-70.  This exegesis was not necessary.  The Fifth Circuit, whose law Texas district courts are bound to follow, has repeatedly recognized that Texas applies the learned intermediary rule to all prescription medical products.  Pustejovsky v. PLIVA, Inc., 623 F.3d 271, 276 (5th Cir. 2010) (generic drug); Ebel v. Eli Lilly & Co., 321 Fed. Appx. 350, 355-56 (5th Cir. 2009) (branded drug); Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 207-08 (5th Cir. 2008) (same); McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006) (same); Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999) (medical device); Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 (5th Cir. 1992) (contrast medium); Hurley v. Lederle Laboratories, 863 F.2d 1173, 1178 (5th Cir. 1988) (vaccine).  The only loophole to the learned intermediary rule ever recognized under Texas law is the so-called “mass vaccination” exception – where a nominally prescription product was dispensed with no doctor, and thus no physician-patient relationship, actually present.  See Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1277-78 (5th Cir. 1974).

However, Murthy was bound and determined to change Texas law.  Rather than follow binding Fifth Circuit precedent, the decision latched onto a “recent[]” decision by a “Texas state appellate court [that] recognized an exception to the learned intermediary doctrine.”  Id. at 970.  That was the so-called “direct-to-consumer” (“DTC”) exception where, according to Murthy, “a drug manufacturer practices consumer marketing that fraudulently touts the drug’s efficacy while failing to warn of the risks.”  Id.  After a long paragraph describing the DTC exception, Murthy pointed out (accurately) that the Texas Supreme Court had yet to pass on any learned intermediary rule exception.  Id.

At this point Murthy imitated Captain Kirk – boldly going where no federal court had gone before.  In the absence of on-point Texas precedent, Murthy elected to “consider, among other sources, treatises, law review commentaries, [and] decisions from other jurisdictions.” Id. at 971 (citation and quotation marks omitted).  What followed were several pages (and long footnotes) that resembled what we saw in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1257-59 (N.J. 1999), or State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 472-75 (W. Va. 2007) – both of which were cited in Murthy – long on rhetoric and citations to law reviews, but notably lacking in precedent that actually did what Murthy was proposing.

What did Murthy propose?

First it jumped on the DTC exception bandwagon.  Id. at 971 (“the Court believes that the Texas Supreme Court will likely agree with the Court of Appeals’ reasoning”).  “By creating and disseminating a promotional video . . ., [defendant] may have circumvented the doctor-patient relationship.” Id.

Then Murthy turned to the “gifts or compensation” that the prescriber-investigator had received for participating in the clinical trial in which plaintiff had been enrolled:

Studies have documented, however, that gifts or compensation from drug companies influence medical professionals’ treatment decisions.  Conflicts of interest also arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials. Indeed, a doctor who receives gifts or compensation from a drug company may no longer, as the prescriber, stand between the drug and the ultimate consumer, as the doctor has an incentive to prescribe a particular drug or, in this case, enroll a patient in a clinical trial. . . .  Under certain circumstances, when a physician receives compensation or gifts from drug companies, his or her role as the neutral decision-maker may be diminished.  As such, dismissal of [plaintiff’s] failure to warn claim on learned intermediary grounds would not be appropriate at this time.  Rather, the Court would have to examine the factual circumstances surrounding the compensation of [plaintiff’s] physician in order to evaluate whether application of the learned intermediary doctrine is appropriate.

Id. at 971-73 (citations, quotation marks and two gigantic footnotes to “studies” omitted).  In the end, however, all this discussion in Murthy was merely an extended exercise in obiter dictum – a judicial hit and run − as the warning claims in that case had to be dismissed for another reason.  See Id. at 975-76 (all warning claims fail under Texas statutory presumption of adequacy in FDA-approved warnings).

The second case, In re Depuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016) (“DOPHI”), purported to turn Murthy’s case-by-case evaluation into a blanket compensation exception:

Moreover, the learned intermediary doctrine does not apply when a manufacturer compensates a physician or incentivizes him or her to use its product.   Murthy v. Abbott Labs, 847 F. Supp. 2d 958, 971-73 (S.D. Texas 2012).   Because of the relationship between [defendant] and [the prescribers], a fact question exists regarding the legitimacy and objectiveness of [these prescribers] that precludes application of the learned intermediary doctrine as a basis for summary judgment.

Id. at *6.

There are a number of problems with this nascent emoluments exception to the learned intermediary rule.  First, its meager support in Texas precedent was blown away when the Texas Supreme Court unanimously reversed the “appellate court” decision that Murthy had followed and just an unanimously adopted the learned intermediary rule:

[W]e hold that a prescription drug manufacturer fulfills its duty to warn end users of its product’s risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly. . . .  Our decision to apply the learned intermediary doctrine in the context of prescription drugs, prescribed through a physician-patient relationship, not only comports with our prior references to the doctrine and many years of Texas case law, but it places us alongside the vast majority of other jurisdictions that have considered the issue. . . .  The underlying rationale for the validity of the learned intermediary doctrine remains just as viable today as stated by Judge Wisdom in 1974.

Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 157-58 (Tex. 2012) (long string-cite footnote and quotation from Reyes, supra omitted).

As for exceptions to the learned intermediary rule, the Texas Supreme Court declined to recognize any.  Id. at 160 n.18 (“we need not determine whether Texas law should recognize exceptions to the learned intermediary doctrine”).  Particularly with respect to the DTC exception Centocor held:

We acknowledge that some situations may require exceptions to the learned intermediary doctrine, but without deciding whether Texas law should recognize a DTC advertising exception when a prescription drug manufacturer distributes intentionally misleading information directly to patients or prospective patients, we hold that, based on the facts of this case, no exception applies.

Id. at 162 (footnote omitted)  (emphasis added).  In the omitted footnote the Texas Supreme Court further criticized the decision that Murthy had blithely predicted it would follow, stating “[t]he court of appeals’ reasoning . . . relegates physicians to a mere dispensary role of prescriptions [and] fails to consider the important professional and ethical standards the law requires of physicians.”  Id. at n.24 (citing Texas statutes governing physician conduct).

After the Centocor reversal, the putative emoluments exception to the learned intermediary rule in Texas rests on precisely zero precedent, only the law journal articles and other studies that Murthy used to justify its prediction.

That brings us to the second point.  Perez and Karl, however wrong we believe them to be (and Karl has since been legislatively overturned), were decided by state high courts.  Those courts have the authority to change state law, even changes based entirely on academic musings, if they so decide.  Murthy and DOPHI, being federal district courts exercising diversity jurisdiction, do not have such authority.  We’ve been over this many times before on the blog.  In the words of the Supreme Court:

A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975).  The Fifth Circuit, which as we mentioned includes Texas, agrees:

No Texas court has interpreted [the law] that way.  And we see no other sufficiently strong indication to make an Erie guess that the Supreme Court of Texas would do so.  [I]t is not for us to adopt innovative theories of Texas law, but simply to apply that law as it currently exists.

Barnett v. DynCorp International, LLC, 831 F.3d 296, 307 (5th Cir. 2016) (citations and quotation marks omitted).

[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it.  The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.

Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008) (citations omitted).  Accord, e.g., Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 616 (5th Cir. 2014); Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 184 (5th Cir. 2012); Holden v. Connex-Metalna Management Consulting GmbH, 302 F.3d 358, 365 (5th Cir. 2002); Batts v. Tow-Motor Forklift Co., 66 F.3d 743, 749 (5th Cir. 1995); Solomon v. Walgreen Co., 975 F.2d 1086, 1089 (5th Cir. 1992); Dean v. Dean, 837 F.2d 1267, 1268 (5th Cir. 1988); United Parcel Service, Inc. v. Weben Industries, Inc., 794 F.2d 1005, 1008 (5th Cir. 1986); Galindo v. Precision American Corp., 754 F.2d 1212, 1217 (5th Cir. 1985).

Finally, our third point is that no other state in the union has adopted any sort of emoluments exception to the learned intermediary rule.  Rather, such claims have been occasionally made, and always rejected, in other states.  That’s quite logical.  Unlike the mass vaccination exception, less accepted exceptions involving consumer choice products (contraceptives) or FDA-mandated DTC warnings – or even the New Jersey-only DTC advertisement “exception” – every other purported exception to the learned intermediary rule has at its justification some kind of communication that avoids the physician-patient relationship.  Claims about financial relationships with prescribers don’t do that.  Rather, they seek to attack an existing relationship using emoluments to claim the physician wasn’t “independent” of the drug/device company.  That’s not a proper “exception” to the learned intermediary rule; that’s a causation issue, if anything other than a smoke screen.  To the extent there is ever any evidence of actual influence over a particular patient’s prescription decision, that is more logically dealt with as tending to defeat a causation defense, but it is not a basis to require direct manufacturer-to-patient warnings where a physician/patient relationship has already been established, which is what exceptions to the learned intermediary rule require.

The first cases to assert financial relationships in opposition to the learned intermediary rule were in Ohio.  In Blatt v. Hamilton, 1986 WL 2925 (Ohio App. March 6, 1986), the plaintiff claimed that his prescriber’s receipt of free drug samples meant that the prescriber should be viewed as the defendant’s agent.  The court disagreed:

The mere fact that a salesman of the manufacturing company gives samples to a doctor and the doctor distributes these samples to a patient, without more, does not prove an agency relationship. . . .  There was no evidence that . . . the manufacturer, had control as to whom, when, in what doses, and in what form, topical or oral, the [drug] was prescribed or distributed by [the prescriber].

Id. at *3 (citation omitted).  Then, in Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875 (Ohio 1991), the Ohio Supreme Court considered facts quite like Murthy – the prescriber had treated the patient under an investigational research protocol and received a per patient payment from the manufacturer.  Id. at 879.  The receipt of routine research-related compensation did not, Tracy ruled, compromise the prescriber’s independence:

Although [defendant] paid [the prescriber] for each participant in the . . . study program, the evidence does not support a finding that [the prescriber] was an employee of [defendant] or that [the prescriber] was acting under the control of [defendant] rather than as a physician exercising his independent judgment. . . .  [Defendant] did not control [the prescriber’s] judgment, duties and responsibilities as he used [the drug] in the treatment of patients.  Accordingly, we find that [the prescriber] was acting as an independent physician in dispensing [the drug] to [plaintiff], that he was a learned intermediary and that the trial court correctly instructed the jury on the learned intermediary doctrine.


Participation in clinical trials similarly did not affect the learned intermediary rule in Little v. Depuy Motech, Inc., 2000 WL 1519962 (S.D. Cal. June 13, 2000).  “The Court [was] not persuaded by Plaintiffs argument that [the prescriber] was not an independent intermediary because he was part of an investigational team” that studied the type of product and surgery at issue.  To the contrary, such study “further support[ed] the finding that [the prescriber] knew about the risks associated with such devices,” and thus defeated causation.  Id. at *9.  Likewise, in a Texas trial court decision neither Murthy nor DOPHI cited, the plaintiff “contend[ed] that [defendant’s] alleged . . . misconduct influenced [the prescriber’s] treatment recommendations because of the fees he received.”  Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *24 (Tex. Dist. Harris Co. June 7, 1999), aff’d mem., 2000 WL 991697 (Tex. App. July 20, 2000).  The court gave that allegation the back of its hand.  “This contention has been rejected.”  Id.

In In re Trasylol Products Liability Litigation, 2011 WL 2117257 (S.D. Fla. May 23, 2011) (applying Alabama law), allegations that the prescriber was “biased because he was a consultant for [defendant], and was paid to attend a Trasylol conference” failed to prevent summary judgment under the learned intermediary rule. Id. at *4.

Plaintiff’s assertions that the learned intermediary doctrine should not apply because [the prescriber] is biased and failed to exercise independent medical judgment do not persuade me. . . .  Plaintiff does not offer evidence that [the prescriber’s] choice to prescribe [the drug] for [plaintiff] was not an informed one, or that he did not exercise individualized medical judgment in making that decision.


In less routine situations, allegations that prescriber held stock in the defendant or received large sums in compensation have not affected the applicability of the learned intermediary rule.  In one of Bexis’ Bone Screw appeals, Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999) (applying Virginia law), the prescriber was a an equity holder in, and a paid consultant for, the defendant.  Id. at 164 (paid to teach surgical procedures, annual $250,000 consulting fee, travel budget, research funds, and 25,000 shares of stock).  The plaintiff argued that, because of these ties, the prescriber “cannot be considered an intermediary, learned or otherwise.”  Id.  Summary judgment under the learned intermediary rule was affirmed because that evidence was not connected to anything that occurred in the plaintiff’s treatment.  “[T]here is no evidence that the consulting relationship between [the prescriber] and [defendant] interfered with [his] independent medical judgment in treating [plaintiff].  On the contrary, the evidence suggests otherwise.”  Id.  Whether financial ties caused injury by lack of “independence” was a “complex question would depend on the nature of the relationship between the manufacturer and the physician and the extent to which the physician was in fact afforded independence in making medical judgments.”  Id. The Trasylol decision followed Talley.  2011 WL 2117257, at *4.

In In re Zyprexa Products Liability Litigation, 2010 WL 348276, at *11 (E.D.N.Y. Jan. 22, 2010) (applying Illinois law), the plaintiff “contend[ed] that summary judgment should not be granted on learned intermediary grounds” because his prescribing physician was “biased” by having “conducted paid research for at least ten pharmaceutical companies, including defendant,” having been “a paid speaker for at least six pharmaceutical companies, including [defendant],” and having “accepting $490,000 in compensation from” drug companies.  Id. at *11.  Such facts did not oust the learned intermediary rule because nothing showed any “bias specific to” the drug or towards the defendant.  Id.

Allegations of compensation of a similar magnitude did not impair California’s learned intermediary rule in In re Vioxx Cases, 2006 WL 6305292 (Cal. Super. Dec. 19, 2006).  A plaintiff argued that his prescriber could “not play the role of learned intermediary because it paid him hundreds of thousands of dollars over the years to conduct research and give lectures.”  Id.  Absent “evidence of actual bias” the compensation didn’t matter:

Payment to a physician, standing alone, does not deprive the physician of learned intermediary status. Such payment for research is a widespread practice, yet the court was unable to find a case where a physician who was paid for research was considered to have abrogated his or her role of learned intermediary.  Therefore, such payments alone do not constitute a “special circumstance” for purposes of setting aside the learned intermediary doctrine.  Indeed, if such payments alone sufficed, a manufacturer would have to obtain the patient list of every physician it pays for research in order to somehow provide direct warnings.


Nor does Murthy itself have much of a track record.  DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601 (S.D.N.Y. 2012), rejected Murthy’s rationale notwithstanding plaintiff’s allegation that her prescriber “may have had a direct financial relationship with [defendant].” Id. at 613.

This argument fails on both the law and the facts.  On the law, plaintiff has not cited any New York decision that adopts an exception to [learned intermediary rule] where physicians received compensation from drug manufacturers.  Murthy applied Texas law, and plaintiff has not demonstrated that Murthy is part of any trend supporting an exception . . . where drug manufacturers compensate physicians.  On the facts, moreover, plaintiff’s allegations that [defendant] compensated [the prescriber] are completely speculative, based entirely on what [defendant] allegedly did in other cases involving other physicians.

Id. at 616 (citation and footnote omitted).  Even assuming what plaintiff claimed was true, however, would not oust the learned intermediary rule, because “[i]t is not clear . . . that manufacturer-compensated physicians would in fact neglect their professional duties to an extent that would undermine” the rule.  Id. at 616 n.6.  See also Calisi v Abbott Laboratories, 2013 WL 5462274, at *3-4 (D. Mass. Feb. 25, 2013) (refusing to follow Murthy and rejecting any “physician compensation exception” to the learned intermediary rule).

Finally, similar emolument-related allegations have failed as challenges to otherwise uncontradicted prescriber testimony.  In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (applying Oklahoma law), summary judgment for the defendant was affirmed under the learned intermediary rule on the basis of the prescriber’s prior independent knowledge of the relevant product risks.  Id. at 1019.  Even with the benefit of a heeding presumption, the plaintiff could not successfully assert the prescriber’s “research for several pharmaceutical companies” as a basis for creating a credibility issue.  Id. at 1024.  Such pharmaceutical affiliations, “standing alone, however, merely offer speculation as to [the prescriber’s] motives for testifying and they are clearly insufficient to call into question either [her]  credibility or the veracity of her statements.”  Id.  “Absent evidence suggesting [the prescriber] was otherwise influenced by the defendants, we . . . find no reason to question her credibility or the truth of her testimony.”  Id.  See Miller v. Pfizer, Inc., 196 F. Supp.2d 1095, 1129 & n.108 (D. Kan. 2002), (“no reasonable jury” could “discredit” unrefuted prescriber testimony based on “bias . . . arising from his business relationship with [defendant], i.e., the fact that at or near the time he prescribed [the drug] for [plaintiff, he] was a paid consultant”), aff’d, 356 F.3d 1326 (10th Cir. 2004).

Based on the above, we believe there is no legal basis for an “exception” to the learned intermediary rule predicated on a prescribing physician having a pre-existing relationship, financial or otherwise, with a defendant manufacturer of prescription medical products.  Perhaps, in an extreme case, there might be actual evidence of bias affecting a particular plaintiff’s medical treatment, but we have yet to see any such case.  Even in the case of significant emoluments, see Talley, Zyprexa, Vioxx, supra, plaintiffs have been unable to establish a jury submissible case of actual, causal bias.  Murthy and DOPHI, exceeded the proper role of federal courts exercising diversity jurisdiction, and their novel predictions are belied by extensive contrary precedent.

In the wake of the defense wins during the last Supreme Court term in Bristol-Myers Squibb Co. v. Superior Court, 137 S.Ct. 1773 (2017) (“BMS”), and BNSF Ry. Co. v. Tyrell, 137 S. Ct. 1549 (2017), we’re retiring the personal jurisdiction cheat sheet we had been maintaining for the last three-plus years since Daimler AG v. Bauman, 134 S.Ct. 746 (2014) (“Bauman”).  That cheat sheet, as our readers know, had covered general jurisdiction cases generally – all areas, not just prescription medical product liability, or product liability generally.  That was a big undertaking, but we did it because litigation tourism was, and remains, a huge issue for our clients.  Now we think that, between them, BMS, BNSF, and Bauman have now settled the larger general jurisdiction point.

So we think we can be more focused going forward in our ongoing monitoring of personal jurisdiction cases. So we’re creating a new cheat sheet devoted to a couple of specific lingering issues.  The first of these issues is the so-called (at least by us) “jurisdiction by consent” theory – that general personal jurisdiction is created in a state when a corporation registers to do business/appoints an agent for service of process in a state.  Since all states have such registration statutes, recognition of that theory would do what the United States Supreme Court has now held multiple times that Due Process prohibits – allowing a corporation to be sued in many jurisdictions where it is not “at home” by anybody, in particular out-of state litigation tourists.  Not surprisingly, since Bauman most courts have rejected this theory (as the cases below demonstrate) as incompatible with Due Process, but since the Supreme Court has not put a stake through itself, plaintiffs still raise it relatively frequently.

Almost all of the older – that is to say, pre-BMS − decisions in this new cheat sheet address jurisdiction by consent theories.  We were keeping specific track of jurisdiction by consent cases in our original cheat sheet, so we’ve pulled out those cases and compiled them here.

Another reason for keeping track of jurisdiction by consent cases is that we litigate a lot in Pennsylvania, and we expect Pennsylvania to be Ground Zero for the battle over this theory.  An unfortunate combination – Pennsylvania’s unique registration statute (42 Pa. C.S.A. §5301) that actually specifies “general” jurisdiction, and adverse pre-Bauman Third Circuit precedent interpreting Pennsylvania law (Bane v. Netlink, Inc., 925 F.2d 637, 640-41 (3d Cir. 1991)) – have led some Pennsylvania courts to ignore constitutional Due Process as interpreted by BMS and Bauman and hold mandatory registration to do business in Pennsylvania somehow to equate with “consent” to general jurisdiction.  E.g., Plumbers’ Local Union No. 690 Health Plan v. Apotex Corp., 2017 WL 3129147, at *11 (E.D. Pa. July 24, 2017); Hegna v. Smitty’s Supply, Inc., 2017 WL 2563231, at *3-4 (E.D. Pa. June 13, 2017); Bors v. Johnson & Johnson, 208 F. Supp.3d 648, 653–55 (E.D. Pa. 2016).

Surely, most Pennsylvania lawyers and judges learned in law school like we did that a state statute can’t override federal constitutional Due Process guarantees, but the litigation tourism industry in Pennsylvania is entrenched and well-funded.  Given that that most of plaintiffs’ other favorite jurisdictions:  California, Illinois, Missouri, and New Jersey, to name a few (see below for details), do not recognize jurisdiction by consent as a matter of state law, we expect to have a ring-side seat as the consent issue is eventually appealed, perhaps interlocutorily, from some Pennsylvania court all the way to the United States Supreme Court if necessary.

The second jurisdictional theory we’ll be keeping track of in this cheat sheet is what we call “BMS-lite.”  This is a litigation tourist’s last gasp in jurisdictions, such as those listed below, that have already rejected jurisdiction by consent. BMS-lite is the variant of specific jurisdiction based on corporate activities related, not to any plaintiff’s case, but to the product in general, that plaintiffs will argue somehow “caused” their injuries in a broad sense and thus justifies opening the courthouse doors in multiple states to litigation tourists.  We discussed an early example of that recently, and the theory’s most notable exemplar, M.M. v. GlaxoSmithKline LLC, 61 N.E.3d 1026 (Ill. App. 2016), is currently pending on certiorari before the Supreme Court. See GlaxoSmithKline LLC v. M.M., No. 16-1171 (U.S. filed March 23, 2017). M.M. (and the post-BMS case we discussed) predicated “specific” jurisdiction on the very non-specific fact that some of the drug’s clinical trials (17 of 361) included in-state investigators.  And, as the certiorari petition states, only “three percent of the study sites in those 17 trials were in [the state], involving a mere two percent of the study participants.”  Petition at 9.  This petition has been distributed for the Supreme Court’s 9/25/17 conference, so M.M could be vacated or reversed sometime this fall.

The type of facts that M.M. seized upon to preserve Illinois’ litigation tourism business  don’t involve the plaintiffs, so “a defendant’s relationship with a third party, standing alone, is an insufficient basis for jurisdiction.” BMS, 137 S. Ct. at 1781 (citation and quotation marks omitted).  Short of a major causal tie – such as the product being manufactured in the forum state in a manufacturing defect case – we don’t think BMS-lite theories are of any greater constitutional validity than what was rejected in BMS itself, so we’ll also be collecting favorable cases that make such holdings.  But so far, given how recent BMS is, we haven’t seen any favorable cases.  We expect them to be coming.

As always, with cheat sheets, we don’t do the other side’s research for them, so we won’t be including any bad cases.

With all this in mind, here is our Post-BMS Personal Jurisdiction Cheat Sheet:

  1. Byham v. National Cibo House Corp., 143 S.E.2d 225 (N.C. 1965) (North Carolina) (non-product liability).  Denial of motion to dismiss affirmed on specific jurisdiction grounds. The casual presence of an agent for service of process is not enough to subject a corporation to suit on causes of action unconnected with the activities within the state.
  2. Ratliff v. Cooper Laboratories, Inc., 444 F.2d 745 (4th Cir. June 29, 1971) (South Carolina) (prescription medical product liability). Denial of motion to dismiss reversed.  Application to do business and the appointment of an agent for service does not establish general personal jurisdiction.
  3. In re Mid-Atlantic Toyota Antitrust Litigation, 525 F. Supp. 1265 (D. Md. Oct. 14, 1981) (West Virginia) (non-product liability).  Motion to dismiss granted.  Registration to do business is not consent to general personal jurisdiction. Modified on other grounds, 541 F. Supp. 62; affirmed on other grounds, 704 F.2d 125.
  4. Pearrow v. National Life & Accident Insurance Co., 703 F.2d 1067, 1069 (8th Cir. 1983) (Arkansas) (non-product liability).  Grant of motion to dismiss affirmed.  Appointment of an agent for service of process does not create general personal jurisdiction.
  5. Gray Line Tours v. Reynolds Electrical & Engineering Co., 238 Cal. Rptr. 419, 421 (Cal. App. June 5. 1987) (California) (non-product liability).  Grant of motion to dismiss affirmed.  Designation of an agent for service of process and qualification to do business in California alone was not consent to general jurisdiction.
  6. Goodyear Tire & Rubber Co. v. Ruby, 540 A.2d 482 (Md. 1988) (Maryland) (non-product liability).  Denial of motion to dismiss reversed.  Agent for service of process insufficient to permit general jurisdiction.
  7. Sandstrom v. ChemLawn Corp., 904 F.2d 83 (1st Cir. May 17, 1990) (Maine) (product liability – non drug/device).  Grant of motion to dismiss affirmed.  Corporation that was licensed to do business in forum and had appointed agent for service of process did not consent to general personal jurisdiction.
  8. Wilson v. Humphreys (Cayman) Ltd., 916 F.2d 1239 (7th Cir. Oct. 24, 1990) (Indiana) (non-product liability).  Denial of motion to dismiss remanded.  Registration to do business alone is not a basis for general personal jurisdiction.
  9. Wenche Siemer v. Learjet Acquisition Corp., 966 F.2d 179 (5th Cir. July 17, 1992) (Texas) (product liability – non drug/device).  Grant of motion to dismiss affirmed.  Registration to do business and appointment of agent for service of process is not consent to general personal jurisdiction.
  10. Leonard v. USA Petroleum Corp., 829 F. Supp. 882 (S.D. Tex. Aug. 17, 1993) (Texas) (non-product liability).  Motion to dismiss granted.  Registration to do business was not automatic consent to general personal jurisdiction.
  11. Arkwright Mutual Insurance Co. v. Transportes de Nuevo Laredo, 879 F.Supp. 699 (S.D. Tex. Aug. 31, 1994) (Texas) (non-product liability).  Motion to dismiss granted.  A certificate to do business does not create general personal jurisdiction.
  12. Samuelson v. Honeywell, 863 F. Supp. 1503 (E.D. Okla. Aug. 31, 1994) (Oklahoma) (non-product liability).  Motion to dismiss granted.  General personal jurisdiction could not be asserted over corporation based on its registration to do business.
  13. Washington Equipment Manufacturing Co. v. Concrete Placing Co., 931 P.2d 170 (Wash App. Feb. 13, 1997) (Washington) (non-product liability).  Grant of motion to dismiss affirmed.  That foreign corporation had registered to do business and appointed agent in state did not confer general personal jurisdiction.
  14. Sofrar, S.A. v. Graham Engineering Corp., 35 F. Supp.2d 919 (S.D. Fla. Feb. 5, 1999) (Florida) (non-product liability). Motion to dismiss granted.  Appointment of an agent for service of process and registration to do business were insufficient to create general personal jurisdiction.
  15. Allied Carriers Exchange, Inc. v. All. Shippers, Inc., 1999 WL 35363796, at *3 (D. Colo. Sept. 22, 1999) (Colorado) (non-product liability).  Transfer granted.  Appointment of a registered agent does not necessarily subject a foreign corporation to general jurisdiction.
  16. Freeman v. Second Judicial District, 1 P.3d 963 (Nev. June 9, 2000) (Nevada) (non-product liability). Mandamus from grant of motion to dismiss denied.  The mere act of appointing an agent to receive service of process does not subject a non-resident corporation to general jurisdiction.
  17. Consolidated Development Corp. v. Sherritt, Inc., 216 F.3d 1286 (11th Cir. July 5, 2000) (federal law) (non-product liability).  Grant of motion to dismiss affirmed.  On a federal claim, the casual presence of a corporate agent for service of process anywhere in the United States is not enough to subject an overseas corporation to general personal jurisdiction.
  18. DVI, Inc. v. Superior Court, 128 Cal. Rptr.2d 683 (Cal. App. Dec. 24, 2002) (California) (non-product liability).  Mandamus granted, reversing denial of motion to dismiss.  Designation of an agent for service of process and qualification to do business alone are insufficient to permit general jurisdiction.
  19. Tyler v. Gaines Motor Lines, Inc., 245 F. Supp.2d 730 (D. Md. Jan. 30, 2003) (Maryland) (non-product liability).  Transfer granted.  Having a registered agent for service of process is not consent to general personal jurisdiction.
  20. Reynolds & Reynolds Holdings, Inc. v. Data Supplies, Inc., 301 F. Supp.2d 545 (E.D. Va. Feb. 5, 2004) (Virginia) (non-product liability).  Motion to dismiss granted.  Complying with registration statutes and appointing an agent for service of process do not amount to consent to general personal jurisdiction.
  21. Norfolk Southern Railway Co. v. Burlington Northern, 2005 WL 1363210 (S.D. Miss. June 2, 2005) (Mississippi) (non-product liability).  Motion to dismiss tentatively granted, pending jurisdictional discovery.  Registration to do business and appointment of agent for service of process is not consent to general personal jurisdiction.
  22. DNH, LLC v. In-N-Out Burgers, 381 F .Supp.2d 559 (E.D. La. June 24, 2005) (Louisiana) (non-product liability).  Motion to dismiss granted.  Qualifying to do business in a state and appointing an agent for service of process there do not amount to a general business presence that could sustain general personal jurisdiction.
  23. Bray v. Fresenius Medical Care Aktiengesellschaft Inc., 2007 WL 7366260 (N.D. Ill. Aug. 30, 2007) (Illinois) (prescription medical product liability). Motion to dismiss granted.  Registration to do business and appointment of agent for service of process is does not alone support general personal jurisdiction.
  24. Keston v. FirstCollect, Inc., 523 F. Supp.2d 1348 (S.D. Fla. Oct. 31, 2007) (Florida) (non-product liability).  Motion to dismiss granted.  Presence of a corporate agent for service of process and a license to do business in a state are not enough to support general personal jurisdiction.
  25. Rosenruist-Gestao E Servicos LDA v. Virgin Enterprises Ltd., 511 F.3d 437 (4th Cir. Dec. 27, 2007) (Virginia) (non-product liability).  Quashing of subpoena affirmed.  Appointment of an agent for service of process is a contact so minimal that it cannot render a company subject to any form of personal jurisdiction consistent with Due Process principles.
  26. Miller v. Robertson, 2008 WL 270761 (D. Utah Jan. 29, 2008) (Utah) (non-product liability).  Motion to dismiss granted.  Appointment of an agent for process and registration to do business do not create general personal jurisdiction.
  27. North American Catholic Education Programming Foundation, Inc. v. Cardinale, 567 F.3d 8 (1st Cir. May 19, 2009) (Rhode Island) (non-product liability).  Motion to dismiss affirmed.  Appointment of an agent of process alone does not suffice to allow for the exercise of general jurisdiction.
  28. Ayers v. Tanami Trading Corp., 2009 WL 1362402 (D. Utah May 14, 2009) (Utah) (non-product liability).  Motion to dismiss denied on other grounds.  Designation of an agent for service of process is insufficient to permit general jurisdiction.
  29. Continental First Federal, Inc. v. Watson Quality Ford, Inc., 2009 WL 2032401 (M.D. Tenn. July 9, 2009) (Mississippi).  Transfer denied.  Registering to do business and appointing an in-state agent for service of process do not establish general personal jurisdiction, so the matter cannot be transferred.
  30. Viko v. World Vision, Inc., 2009 WL 2230919 (D. Vt. July 24, 2009) (Vermont) (non-product liability).  Transfer granted.  A defendant foreign corporation’s registered agent does not, by itself, confer general personal jurisdiction over the defendant.
  31. Advanced Datacomm Testing Corp. v. PDIO, Inc., 2009 WL 2477559 (D. Md. Aug. 11, 2009) (Maryland) (non-product liability).  Transfer granted.  Registration to do business and appointment of an agent for service of process do not create general personal jurisdiction.
  32. Cossaboon v. Maine Medical Center, 600 F.3d 25 (1st Cir. 2010) (New Hampshire) (non-product liability).  Dismissal for lack of personal jurisdiction affirmed.  Registration to do business alone is an insufficient basis on which to assert personal jurisdiction.
  33. Gallaher v. KBR, Inc., 2010 WL 2901626 (N.D.W. Va. July 21, 2010) (West Virginia) (non-product liability).  Motion to dismiss granted.  Registration to do business and having an agent for service of process are not sufficient to establish general personal jurisdiction.
  34. Harrington v. C.H. Nickerson & Co., 2010 WL 3385034 (D.R.I. Aug. 25, 2010) (Rhode Island (non-product liability). In light of constitutional limitations on personal jurisdiction, registration to do business and appointment of an agent for service of process do not constitute consent to general jurisdiction.
  35. King v. American Family Mutual Insurance Co., 632 F.3d 570 (9th Cir. Jan. 31, 2011) (Montana) (non-product liability).  Grant of motion to dismiss affirmed.  Appointment of an agent for service of process does not, standing alone, create general personal jurisdiction in the absence of causal connection to the state.
  36. Crochet v. Wal-Mart Stores, Inc., 2012 WL 489204 (W.D. La. Feb. 13, 2012) (Louisiana) (non-product liability).  Motion to dismiss granted.  Appointment of an agent for service of process and registration to do business within the state is insufficient to create general personal jurisdiction.
  37. Kuennen v. Stryker Corp., 2013 WL 5873277 (W.D. Va. Oct. 30, 2013) (District of Columbia) (prescription medical product liability). Summary judgment granted.  A business certificate and appointed agent are not independent support for general jurisdiction.
  38. Louisiana Limestone & Logistics, LLC v. Granite Group International, Inc., 2014 WL 1217956 (W.D. La. Feb. 28, 2014) (Louisiana) (non-product liability).  Motion to dismiss granted.  Presence of the registered agent and registered business office alone is insufficient to support the exercise of general jurisdiction.
  39. Robinson v. Knight Protective Service, Inc., 2014 WL 1326096 (S.D. Miss. March 31, 2014) (Mississippi) (non-product liability).  Motion to dismiss granted.  Registration to do business and appointment of agent for service of process is not consent to general personal jurisdiction.
  40. Brown v. CBS Corp., 19 F. Supp.3d 390 (D. Conn. May 14, 2014) (Connecticut) (product liability – non drug/device).  Asbestos motion to dismiss granted.  Corporate registration/agent for service of process insufficient consent to justify jurisdiction after Bauman. Affirmed 2/19/16 see below.
  41. Gliklad v. Bank Hapoalim B.M., 2014 WL 3899209 (N.Y. Sup. Aug. 4, 2014) (New York) (non-product liability).  Motion to dismiss granted.  Rejecting jurisdiction through consent by service on registered agent.
  42. Chambers v. Weinstein, 2014 WL 4276910, 997 N.Y.S.2d 668 (table) (N.Y. Sup. Aug. 22, 2014) (New York) (non-product liability). Motion to dismiss granted. Severance granted.  No jurisdiction on the basis of consent by registration of agent in-state.
  43. Recao v. Bell Helicopter Textron, Inc., 2014 WL 12595302 (S.D. Fla. Sept. 23, 2014) (Florida) (product liability – non drug/device).  Motion to dismiss granted.  Registration to do business and having a registered agent is insufficient to create general personal jurisdiction.
  44. Sullivan v. Sony Music Entertainment, 2014 WL 5473142 (N.D. Ill. Oct. 29, 2014) (Illinois) (non-product liability). Motion to dismiss granted.   Registration to do business and having agent for service of process is not consent to general jurisdiction.
  45. AstraZeneca AB v. Mylan Pharmaceuticals, Inc., 72 F. Supp.3d 549 (D. Del. Nov. 5, 2014), certified for interlocutory appeal on other issue, 2014 WL 7533913 (D. Del. Dec. 17, 2014) (Delaware) (non-product liability).  Motion to dismiss granted in part.  No general jurisdiction through consent by registration to do business.  Denying motion to dismiss on specific jurisdiction.
  46. Shrum v. Big Lots Stores, Inc., 2014 WL 6888446 (C.D. Ill. Dec. 8, 2014) (Illinois) (product liability – non drug/device). Motion to dismiss granted.  No general jurisdiction by consent for having registration and agent for service of process.
  47. Magdalena v. Lins, 999 N.Y.S.2d 44 (N.Y.A.D. Dec. 16, 2014) (New York) (non-product liability). Denial of motion to dismiss reversed.  General jurisdiction not provided by consent by registration to do business.
  48. Smith v. Union Carbide Corp., 2015 WL 191118 (Mo. Cir. St. Louis City Jan. 12, 2015) (Missouri) (product liability – non drug/device). Motion to dismiss granted.  Asbestos defendant’s registration to do business and agent for service of process insufficient to create general jurisdiction by consent.
  49. Chatwal Hotels & Resorts LLC v. Dollywood Co., 90 F. Supp.3d 97 (S.D.N.Y. Feb. 6, 2015) (New York) (non-product liability). Motion to dismiss granted in part and denied in part.  Rejecting consent by registering to do business.
  50. Fiduciary Network, LLC v. Buehler, 2015 WL 2165953 (N.D. Tex. May 8, 2015) (Texas) (non-product liability). Motion to remand denied.  Rejecting general jurisdiction by consent through “registration of an agent for process and registration to do business.”
  51. Keeley v. Pfizer Inc., 2015 WL 3999488 (E.D. Mo. July 1, 2015) (Missouri) (prescription medical product liability). Motion to dismiss granted.  No consent to general jurisdiction by registration to do business.
  52. Public Impact, LLC v. Boston Consulting Group, Inc., 117 F. Supp.3d 732 (M.D.N.C. Aug. 3, 2015) (North Carolina) (non-product liability). Motion to dismiss granted.  Rejecting jurisdiction by consent by registration to do business.
  53. McCourt v. A.O. Smith Water Products Co., 2015 WL 4997403 (D.N.J. Aug. 20, 2015) (New Jersey) (product liability – non drug/device). Motion to dismiss granted in asbestos case.  No consent to jurisdiction by registering to do business.
  54. Imax Corp. v. The Essel Group, 2015 WL 6087606 (N.Y. Sup. Oct. 9, 2015) (New York) (non-product liability). Motion to dismiss granted.  Rejecting jurisdiction by consent through registration to do business.
  55. Dimitrov v. Nissan North America, Inc., 2015 WL 9304490 (N.D. Ill. Dec. 22, 2015) (Illinois) (non-product liability). Motion to dismiss granted.  Defendant did not consent to jurisdiction by registering to do business.
  56. Brown v. Lockheed-Martin Corp., 814 F.3d 619 (2d Cir. Feb. 18, 2016) (Connecticut) (product liability – non drug/device).  “If mere registration and the accompanying appointment of an in state agent − without an express consent to general jurisdiction – nonetheless sufficed to confer general jurisdiction by implicit consent, every corporation would be subject to general jurisdiction in every state in which it registered, and Daimler’s ruling would be robbed of meaning by a back‐door thief.”   Affirming 19 F. Supp.3d 390, above.
  57. Hood v. Ascent Medical Corp., 2016 WL 1366920 (Mag. S.D.N.Y. March 3, 2016) (New York) (non-product liability).  Recommending vacation of default judgment. Jurisdiction by consent argument based on contractual choice of law provision “borderline frivolous.”  Adopted 2016 WL 3453656, below.
  58. Firefighters’ Retirement System v. Royal Bank PLC, 2016 WL 1254366 (M.D. La. March 29, 2016) (Louisiana) (non-product liability).  Motion to dismiss granted. Registration to do business, appointment of agent for service of process, and payment of taxes insufficient.  Registration was not consent to general jurisdiction.
  59. Thompson v. Carnival Corp., 174 F. Supp.3d 1327 (S.D. Fla. March 30, 2016) (maritime law) (product liability – non drug/device).  Motion to dismiss granted. Contractual consent to jurisdiction insufficient absent independent basis for jurisdiction. Rule 4(k)(2) cannot confer general jurisdiction where defendant is not “at home.”
  60. In re Foreign Exchange Benchmark Rates Antitrust Litigation, 2016 WL 1268267 (S.D.N.Y. March 31, 2016) (New York) (non-product liability).  Granting motion to dismiss.  Registration was not consent to general jurisdiction. General jurisdiction criteria the same under both federal and state law.
  61. Hovsepian v. Crane Co., 2016 WL 2997641 (E.D. Mo. April 13, 2016) (Missouri) (product liability – non drug/device).  Granting motion to dismiss.  Out-of-state asbestos plaintiff failed to establish general personal jurisdiction or consent to general jurisdiction.
  62. Genuine Parts Co. v. Cepec, 137 A.3d 123 (Del. April 18, 2016) (Delaware) (product liability – non drug/device). Denial of motion to dismiss reversed.  Registration to do business and appointment of agent for service of process do not establish consent to general jurisdiction.  Prior contrary precedent is no longer viable after Bauman.
  63. Display Works, LLC, v. Bartley, 182 F. Supp.3d 166 (D. N.J. April 25, 2016) (New Jersey) (non-product liability). Motion to dismiss granted.  Registration to do business is not consent to general jurisdiction, nor is doing business in a state.  Prior contrary precedent is no longer viable after Bauman.
  64. Beard v. Smithkline Beecham Corp., 2016 WL 1746113 (E.D. Mo. May 3, 2016) (Missouri) (prescription medical product liability). Motion to transfer granted.  Registration to do business and appointment of agent do not establish consent to general jurisdiction.  Prior contrary precedent is no longer viable after Bauman.
  65. In Re: Zofran (Ondansetron) Products Liability Litigation, 2016 WL 2349105 (D. Mass. May 4, 2016) (Massachusetts) (prescription medical product liability). Motion to dismiss granted.  Motion to remand denied.  Registration to do business and appointment of agent for service do not establish consent to general jurisdiction.  Prior contrary precedent is no longer viable after Bauman, and would “distort” the registration statute.
  66. Leibovitch v. Islamic Republic of Iran, 188 F. Supp.3d 734 (N.D. Ill. May 19, 2016) (Illinois) (non-product liability). Motions to quash granted. Bauman is not limited to defendants and applies to third-party subpoenas.  Registration to do business and appointment of agent for service do not establish general jurisdiction by consent or waiver.  Prior contrary precedent is no longer viable after Bauman.
  67. Guillette v. PD-RX Pharmaceuticals. Inc., 2016 WL 3094073 (W.D. Okla. June 1, 2016) (Oklahoma) (prescription medical product liability). Motion to dismiss granted.  Registration to do business and appointment of agent for service of process do not establish consent to general jurisdiction.
  68. Manning v. PD-RX Pharmaceuticals Inc., 2016 WL 3094075 (W.D. Okla. June 1, 2016) (Oklahoma) (prescription medical product liability). Motion to dismiss granted.  Registration to do business and appointment of agent for service is not consent to general jurisdiction.
  69. Nauman v. PD-RX Pharmaceuticals Inc., 2016 WL 3094081 (W.D. Okla. June 1, 2016) (Oklahoma) (prescription medical product liability). Motion to dismiss granted.  Registration to do business and appointment of agent for service is not consent to general jurisdiction.
  70. Magna Powertrain De Mexico S.A. De C.V. v. Momentive Performance Materials USA LLC, 2016 WL 3574652 (E.D. Mich. June 16, 2016) (Michigan) (product liability – non drug/device). Motion to transfer granted.  Registration to do business and appointment of agent for service is not consent to general jurisdiction.
  71. Hood v. Ascent Medical Corp., 2016 WL 3453656 (S.D.N.Y. June 20, 2016) (New York) (non-product liability). Adopting magistrate’s recommendation (2016 WL 1366920, above) to grant motion to dismiss.  Forum selection clause not consent to general jurisdiction. Affirmed ___ F. Appx. ___, 2017 WL 2274276, below.
  72. Johnson v. Barrier, 2016 WL 3520157 (N.D. Ill. June 28, 2016) (Illinois) (non-product liability). Motion to dismiss granted.  Consent to jurisdiction in previous cases not judicial estoppel.
  73. Singh v. Diesel Transportation, LLC, 2016 WL 3647992 (D. N.J. July 7, 2016) (New Jersey) (non-product liability). Motion to transfer granted.  No consent to jurisdiction through registration and appointment of agent for service.
  74. Bristol-Myers Squibb Co. v. Superior Court, 377 P.3d 874 (August 29, 2016) (California) (prescription medical product liability). Denial of dismissal affirmed on other grounds.  Registration to do business and appointment of an agent for service of process does not create general personal jurisdiction. Reversed 137 S. Ct. 1773, on other (very important) grounds as discussed here.
  75. Bonkowski v. HP Hood, LLC, 2016 WL 4536868 (E.D.N.Y. Aug. 30, 2016) (New York) (product liability – non-drug/device). Motion to transfer granted.  No consent to general jurisdiction by registration to do business.  Prior contrary consent precedent no longer viable after Bauman.
  76. Erwin v. Ford Motor Co., 2016 WL 7655398 (M.D. Fla. Aug. 31, 2016) (Florida) (product liability – non-drug/device). Motion to dismiss deferred to consider transfer.  No consent to general jurisdiction by appointment of agent for service of process.
  77. Magill v. Ford Motor Co., 379 P.3d 1033, 2016 WL 4820223 (Colo. Sept. 12, 2016) (Colorado) (product liability – non drug/device). Reversing denial of motion to dismiss.  Registration to do business and appointment of agent for service is not consent to general jurisdiction.
  78. Sciortino v. CMG Capital Management Group, Inc., 2016 WL 4799099 (E.D. La. Sept. 14, 2016) (Louisiana) (non-product liability). Motion to dismiss granted.  Registration to sell securities in state not consent to general jurisdiction.
  79. Gulf Coast Bank & Trust Co, v. Designed Conveyor Systems, LLC, 2016 WL 4939113 (M.D. La. Sept. 14, 2016) (Louisiana) (non-product liability). Motion to dismiss granted.  No consent to jurisdiction through licensing, registration, or appointment of agent for service of process.
  80. George v. A.W. Chesterton Co., 2016 WL 4945331 (W.D. Pa. Sept. 16, 2016) (Pennsylvania) (product liability – non-drug/device). Remanding for lack of jurisdiction.  Registration to do business is not retroactive consent to general jurisdiction in asbestos case where it occurred after the alleged injury.
  81. U.S. Bank National Ass’n v. Bank of America, N.A., 2016 WL 5118298 (S.D.N.Y. Sept. 20, 2016) (Indiana) (non-product liability). Retransfer denied.  Registration and appointment of in-state agent is neither consent to nor waiver of general jurisdiction.
  82. Addelson v. Sanofi S.A., 2016 WL 6216124 (E.D. Mo. Oct. 25, 2016) (Missouri) (prescription medical product liability).  Motion to dismiss granted.  Registration to do business and appointment of agent is not consent to general jurisdiction.  Prior contrary precedent is no longer viable after Bauman.
  83. Perez v. Air and Liquid Systems Corp., 2016 WL 7049153 (S.D. Ill. Dec. 2, 2016) (Illinois) (product liability – non-drug/device). Motion to dismiss granted.  Asbestos case.  No consent to jurisdiction by registration and appointment of agent.
  84. Taormina v. Thrifty Car Rental, 2016 WL 7392214 (S.D.N.Y. Dec. 21, 2016) (New York) (non-product liability). Motion to dismiss granted.  No consent to jurisdiction through registration and appointment of agent for service.  Prior contrary precedent no longer viable after Bauman.
  85. Minholz v. Lockheed Martin Corp., 2016 WL 7496129 (N.D.N.Y. Dec. 30, 2016) (New York) (product liability – non-drug/device). Motion to dismiss granted.  No consent to jurisdiction through registration and appointment of agent for service.  Prior contrary precedent no longer viable after Bauman.
  86. Gulf Coast Bank v. Designed Conveyor Systems, LLC, 2017 WL 120645 (M.D. La. Jan. 12, 2017) (Louisiana) (non-product liability). Denying motion to alter judgment.  No consent to jurisdiction through registration and appointment of agent for service.  Prior contrary precedent no longer viable after Bauman, and interpreting a registration statute as providing consent to general jurisdiction would “rob [Bauman] of its central meaning.”
  87. Famular v. Whirlpool Corp., 2017 WL 280821 (S.D.N.Y. Jan. 19, 2017) (New York) (non-product liability). Motion to dismiss representative plaintiffs for out-of-state class actions granted.  No consent to jurisdiction through registration and appointment of agent for service.  Prior contrary precedent no longer viable after Bauman.
  88. Sullivan v. Barclays PLC, 2017 WL 685570 (S.D.N.Y. Feb. 21, 2017) (New York) (non-product liability). Motion to dismiss granted.  Forum selection clause is not consent to general jurisdiction.  Neither is registration to do business.
  89. State ex rel. Norfolk Southern Railway Co. v. Dolan, 512 S.W.3d 41 (Mo. Feb. 28, 2017) (Missouri) (non-product liability). Writ of prohibition issued.  No consent to jurisdiction through registration and appointment of agent.  Contrary prior precedent no longer viable after Bauman.
  90. Figueroa v. BNSF Railway Co., 390 P.3d 1019 (Or. March 2, 2017) (Oregon) (non-product liability). Mandamus granted.  No consent to general jurisdiction through registration and appointment of agent for service of process.  Registration is not implied consent to personal jurisdiction.
  91. Am Trust v. UBS AG, ___ F. Appx. ___, 2017 WL 836080 (9th Cir. March 3, 2017) (California) (non-product liability). Affirming dismissal for lack of jurisdiction.  No consent to jurisdiction through registration and appointment of agent.  Acceptance of service in prior litigation insufficient.
  92. Phoenix Insurance Co. v. Cincinnati Indemnity Co., 2017 U.S. Dist. Lexis 109977 (D.R.I. March 3, 2017) (Rhode Island) (non-product liability).  Motion to transfer granted. No consent to general jurisdiction through insurance registration and appointment of the agent for service.  The statues cannot be “construed as a consent or submission to personal jurisdiction,” and if they could they would violate Due Process.
  93. Kearns v. New York Community Bank, 2017 WL 1148418 (Kan. App. March 24, 2017) (Kansas) (non-product liability) (unpublished). Affirming dismissal for lack of jurisdiction.  Consent to jurisdiction by registration to do business in-state by non-party subsidiary insufficient.
  94. Muenstermann v. United States, 2017 WL 1408037 (S.D. Ill. April 20, 2017) (Illinois) (non-product liability).  Motion to dismiss granted.  No jurisdiction through registration and appointment of agent for service.  Contrary prior precedent no longer viable after Bauman.
  95. MacCormack v. The Adel Wiggins Group, 2017 WL 1426009 (E.D. Mo. April 21, 2017) (Missouri) (product liability – non-drug/device).  Granting motion for reconsideration, and dismissing.  No consent to jurisdiction for registration and an appointment of agent for service.  Contrary prior precedent no longer viable under Norfolk Southern v. Dolan.
  96. Justiniano v. First Student Management LLC, 2017 WL 1592564 (E.D.N.Y. April 26, 2017) (New York) (non-product liability).  Motion to transfer granted.  No consent to jurisdiction through registration and appointment of agent for service.  Contrary prior precedent no longer viable after Bauman.
  97. Wal-Mart Stores, Inc. v. Lemaire, ___ P.3d ___, 2017 WL 1954809 (Ariz. App. May 11, 2017) (Arizona) (non-product liability).  Reversing denial of motion to dismiss.  No express or implied consent to jurisdiction through registration and appointment of agent for service.
  98. Antoon v. Securus Technologies, Inc., 2017 WL 2124466 (W.D. Ark. May 15, 2017) (Arkansas) (non-product liability).  Motion to dismiss granted. No consent to jurisdiction through registration and appointment of agent for service, where statute provided express jurisdictional restriction, and “exception [would be] so large as to swallow the rule.”
  99. Matthews v. BNSF Railway Co., 2017 WL 2266891 (W.D. Mo. May 23, 2017) (Missouri) (non-product liability).  Motion for reconsideration granted and transferred.  No consent to jurisdiction for registration and appointment of agent for service.
  100. Hood v. Ascent Medical Corp., ___ F. Appx. ___, 2017 WL 2274276 (2d Cir. May 24, 2017) (New York) (non-product liability). Affirming grant of motion to dismiss.  Forum selection clause insufficient to constitute consent to general jurisdiction. Affirming, 2016 WL 1366920, and 2016 WL 3453656, above.
  101. Famular v. Whirlpool Corp., 2017 WL 2470844 (S.D.N.Y. June 7, 2017) (New York) (non-product liability).  Motion to dismiss granted as to out-of-state plaintiffs.  No consent to jurisdiction through registration and appointment of agent for service. Contrary prior precedent longer viable after Bauman.
  102. Siegfried v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 2778107 (E.D. Mo. June 27, 2017) (Missouri) (prescription medical product liability).  Motion to dismiss granted.  Out-of-state plaintiffs lacked personal jurisdiction Bauman and BMS.  No consent to jurisdiction through and appointment of agent for service.
  103. Everett v. Aurora Pump Co., 2017 WL 2778091 (E.D. Mo. June 27, 2017) (Missouri) (product liability – non-drug/device).  Motion to dismiss granted.  No consent to jurisdiction through registration and appointment of agent for service.
  104. Boswell v. Cable Services Co., 2017 WL 2815077 (D.N.J. June 28, 2017) (New Jersey) (non-product liability).  Motion to dismiss granted.  No consent to jurisdiction through registration and appointment of agent for service.  Statute lacked “express language” indicating consent.  Contrary prior precedent no longer viable after Bauman.
  105. Segregated Account of Ambac Assurance Corp. v. Countrywide Home Loans, ___ N.W.2d ___, 2017 WL 2824607 (Wis. June 30, 2017) (Wisconsin) (non-product liability).  Reversing denial of dismissal and remanding.  No consent to jurisdiction through registration and appointment of the agent.  Statute contains no language regarding consent or jurisdiction.  Contrary prior precedent no longer viable after Bauman.
  106. Dutch Run-Mays Draft, LLC v. Wolf Block, LLP, ___ A.3d ___, 2017 WL 2854420 (N.J. Super. App. Div. July 5, 2017) (New Jersey) (non-product liability).  Dismissal for lack of jurisdiction affirmed.  Registration to do business and appointment of agent for service of process do not establish consent to general jurisdiction.  Prior contrary precedent is no longer viable after Bauman.
  107. JPB Installers, LLC v. Dancker, Sellew & Douglas, Inc., 2017 WL 2881142 (M.D.N.C. July 6, 2017) (North Carolina) (non-product liability).  Motion to dismiss granted.  Registration to do business does not establish general personal jurisdiction.

Today we feature another guest post from our European correspondents, Reed Smith partner Marilyn Moberg and associate Kathryn Bond.  There has been another significant decision from the Court of Justice (its description, not ours) of the European Union, and once again it is bad news for manufacturers of life-saving prescription products – this time vaccines.  Without stealing our guest bloggers’ thunder, let’s just say that the European attitude appears to be “Daubert?  We don’t need no stinkin’ Daubert.”  For the details, see below.  As always our guest bloggers deserve 100% of the credit (and any blame) for what they write.


Bonjour à tous.

Now that we have completely exhausted our entire high school French vocabulary, for today’s blog post we are traveling back across the Atlantic to France and Luxembourg. Today, we examine a recent judgment of the Court of Justice of the European Union relating to the evidentiary requirements for finding a causal link between a vaccine and an unrelated disease where there is no medical proof to support the existence of such a causal link. For our American readers who are familiar with the way vaccine cases used to be litigated, one may get a feeling of “déja vu,” and not in a good way.

If we cast our minds back to the 1980s scare over the DPT vaccine, large jury awards were given to plaintiffs despite the fact that most public health officials did not believe that there was a link between the vaccine and certain autism spectrum disorders. As a result of these cases, a number of vaccine makers decided to cease production. For the United States government, this development was worrying and threatened a drop in important childhood vaccinations. In order to encourage the continued production of vaccines, Congress passed the National Childhood Vaccine Injury Act, which set up the National Vaccine Injury Compensation Program (NVICP) in 1988 to compensate individuals (or their families) allegedly injured by certain covered childhood vaccines. The compensation scheme is funded by a tax on vaccines purchased. The scheme applies only to conditions that have already been determined administratively to be associated with the vaccine, therefore relieving (i) the plaintiff of the burden of proving a general causal link between the vaccine and the injury; and (ii) the vaccine producer of the cost of defending or settling expensive civil liability cases. The plaintiff is still required to prove that, on balance, a specific causal link between the vaccine and the injury. Although this scheme is limited to certain injuries caused by certain vaccines, it significantly reduced the number of product liability claims against manufacturers for vaccines. See generally Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226-30 (2011) (describing NVICP and reasons for its enactment).

Now, back to the case at hand, which is Case C-621/15, N.W. and Others v Sanofi Pasteur MSD and Others (NW v Sanofi). The judgment has been widely reported as particularly favorable for claimants because it confirms that a claimant can establish, despite total lack of individualized corroborating medical evidence, a causal link between the vaccine and the disease where there is “serious, specific and consistent evidence” that a causal link exists.

By way of background, EU law on product liability is set out in the Product Liability Directive 85/374/EEC. Article 4 of the Directive stipulates that, in order to win a product liability claim, the claimant must prove the damage, the defect and the causal relationship between the defect and the damage. In other words, and unsurprisingly, the burden of proof is on the injured party.

In the NW v Sanofi case, NW developed multiple sclerosis a short period after being vaccinated against Hepatitis B. Although medical research has not established a connection between the Hepatitis B vaccine and multiple sclerosis, the claimant sought to rely on a provision of French case law of the Cour de Cassation (the highest French court). The case law provides that, in relation to the liability of producers of vaccines, proof of a causal link can be derived from “serious, specific and consistent presumptions” in the absence of medical research. The claimant believed that, on the basis of this case law, the French courts could take into account the following facts to find a “lien de causalité” or “causal link”: (1) the short time lapse between the administration of the vaccine and the onset of the disease; and (2) the patient’s lack of any personal or family history of the disease. Essentially, any product manufacturer becomes an insurer against any qualifying medical condition that might manifest itself during this short time lapse, regardless of scientific basis.

At first instance, the Tribunal de Grande Instance in Nanterre, France, found in favour of the claimant, but the decision was subsequently overturned on appeal by the Cour d’Appel in Versailles, France and the Cour d’Appel in Paris, France. When the case finally reached the Cour de Cassation, the judges faced some difficult questions concerning the compatibility of its case law with Article 4 of the Product Liability Directive. In particular, does Article 4 override France’s own national rules regarding the level of proof required to find a causal link between the defect and the damage? This was clearly a question of interpretation of EU law. The Cour de Cassation therefore referred this question to the Court of Justice of the European Union (“CJEU”) for a preliminary ruling.

For those (most) of you not familiar with EU procedural law, here is some important background. The CJEU is based in Luxembourg and is the highest court of the European Union. The CJEU plays an important role in the EU, which includes interpreting EU law to make sure it is applied in the same way across all 28 (soon to be 27) Member States. One of the ways in which the CJEU achieves this is through the “renvoi préjudiciel” or “reference for a preliminary ruling,” which bears some resemblance to the American procedure of federal courts certifying state-law questions to state high courts for resolution. This procedure enables the courts of each Member State to refer questions to the CJEU for a ruling on the interpretation of a specific point of EU law. When the CJEU gives its ruling, its sole mandate is to rule on the point of EU law in question only.

In the case of NW v Sanofi, the CJEU considered the following points:

Whether Article 4 precludes the French Courts from considering its own national evidentiary rules (including those described above), in circumstances where medical research has not established a causal link between the administering of the vaccine and the disease, when determining whether there is a defect in the vaccine and whether there is a causal link between that defect and the disease?

In response to this question, the CJEU gave the following analysis at paras [18]-[43]:

  1. It is ultimately the injured party’s responsibility to prove the damage, the defect and the causal relationship between the defect and the damage (para [19]).
  2. The Product Liability Directive does not contain any definition of the concept of “causal relationship” for the purposes of Article 4 (para [22]). This means that, taking into account the principle of procedural autonomy of each Member State, it is for each Member State to establish:
    1. the way in which evidence is to be provided;
    2. what evidence is admissible;
    3. the principles governing the national court’s assessment of the evidence; and
    4. the level of proof required (para [25]).
  3. The national court’s procedural autonomy should not, however, undermine the effectiveness of EU procedural rules. For example, the national rules should not bring about a reversal of the burden of proof set out in Article 4 of the Product Liability Directive (paras [26]-[27]).
  4. The national courts must ensure that the evidence provided is sufficiently serious, specific and consistent to warrant the conclusion that, notwithstanding the evidence produced by the producer, a defect in the product appears to be the most plausible explanation for the occurrence of the damage, with the result that the defect and the causal link may reasonably be considered to be established (see para [37]).
  5. Although the CJEU is not mandated to apply EU law to the facts of a specific case, the CJEU commented that facts such as:
    1. a short time lapse between the administration of the vaccine and the occurrence of the disease;
    2. the existence of a significant number of reported cases of the disease occurring following such vaccines being administered; and
    3. a lack of personal and familial history of the disease,Based on the above analysis, the answer to the question was a clear “non,” provided that the specific application of a national court’s evidentiary rules do not result in the burden of proof in Article 4 being disregarded or undermined.  Whether Article 4 precludes national evidentiary rules that are based on presumptions (such as a set of pre-determined causation-related facts) according to which, in circumstances where medical research has not established a causal link between the administering of the vaccine and the disease, a causal link can automatically be established?
    4. The second question raised by the Cour de Cassation was the following:
    5. could lead a national court to consider that the injured party has discharged its burden of proof under Article 4 (see para [41]).

In response to this question, the CJEU raised strong concerns. In particular, the CJEU held that establishing a set of pre-determined facts to automatically establish a causal link would make such presumptions irrefutable. This would therefore deprive the defendant from adducing evidence or putting forward arguments (such as scientific arguments) to rebut that presumption, which would not be a fair or effective result. Even if the defendant could rebut the presumption, the burden of proof would effectively be on the defendant rather than the injured party. This would therefore undermine the burden of proof of the injured party set out in Article 4 of the Product Liability Directive.

Based on the above analysis, the answer to the question was a strong “oui.”

There is no general Daubert requirement of verifiable scientific basis for causation in the EU. The CJEU’s judgment is a disturbing development as it lowers even further the standard of proof required from the injured party. However, as highlighted above, the national courts must ensure that the evidence provided is sufficiently serious, specific and consistent (however that might be interpreted) to warrant the conclusion that, notwithstanding the producer’s evidence, a defect in the product appears to be the most plausible explanation for the occurrence of the damage. Although the standard is lower, it is still a threshold. If the CJEU were to find causation without medical proof, the evidence brought by the injured party would have to be very compelling.

Now the pessimists – or perhaps “realists” – out there who remember the pre-NVICP vaccine litigation cases may think that this could make it too easy for plaintiffs to establish causation where there is no corroborating medical evidence and, as happened in the United States, result in a downturn in the availability of vaccines in Europe. Experts in the field are clearly concerned.

However, the full implications of this case are still unclear, and will perhaps remain unclear for some time. The case clearly reduces the burden of proof on the plaintiff, thus raising the spectre of adverse market consequences, but it remains to be seen how this will be adopted in practice by the national courts of the Member States.

In terms of the case at hand, the CJEU did not appear to contradict the most recent decision of the Cour d’Appel in Paris, which found that the plaintiff had not proved causation. It could (we wish) be a Pyrrhic victory for the plaintiff who, ironically, will likely be found by the relevant French court to have not proved causation.

We should also remember that this CJEU case concerns the application of national evidentiary rules. In this case, the French law of evidence set out in its Civil Code. As each Member State will have its own national evidentiary rules, the impact of the CJEU decision will vary depending on the relevant Member State’s own evidentiary rules.

Causation or no causation, that remains the question

As Voltaire so intelligently put:

« Le hasard est un mot vide; rien ne peut exister sans une cause »

(“Chance is a word void of sense; nothing can exist without a cause”)

In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in surgery.  Surgeonless surgery would “allow[] work around the clock with higher productivity, accuracy, and efficiency as well as shorter hospital stays and faster recovery.” Science, at 28.  The listed drawbacks were:  “technical difficulties in the midst of a surgery,” the “loss of relevance of surgeons,” and “how to equip artificial intelligence with tools to handle . . . inherent moral responsibility.”  Id.

Fascinating.  In addition to driverless cars, do we also need to contemplate surgeonless surgery?  We’ve long been aware of the advent of robots as an adjunct to surgery.  Bexis filed a (largely unsuccessful) PLAC amicus brief in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), but the surgical robot in Taylor in no way threatened to displace the surgeon, and the applicability (if not application) of the learned intermediary rule in Taylor was undisputed.  Id. at 526-28.

We checked the Internet, and sure enough there were plenty of articles from reputable sources:

Completely automated robotic surgery: on the horizon?” (Reuters)

Autonomous Robot Surgeon Bests Humans in World First” (Inst. of Electrical & Electronics Engineers)

Would you let a robot perform your surgery by itself?” (CNN)

The Future Of Robotic Surgery” (Forbes)

Science fiction?  Apparently not anymore.  As the last article stated:

Having totally automated procedures was once a thing of science fiction, very futuristic and not very practical. . . .  But over the last three or four years, technology has evolved and this has become a possibility.  I think potentially we’ll see some automated tasks in the medical field in the next five years.

All these articles are from 2016.

Since we’ll still be practicing law in five years, we thought we’d better start thinking about this.

First, will there be product liability litigation involving autonomous surgical robots at all?  Existing surgical robots appear to have been “cleared” by the FDA, Taylor, 389 P.3d at 520, so there hasn’t been much of a preemption barrier to bringing suit.  We’re not FDA regulatory specialists, but we have some doubt about how a fully autonomous surgical robot – described as something out of “science fiction” in the articles – could be marketed as “substantially equivalent” to existing devices.  If autonomous surgical robots, or the software that runs them, must go through FDA pre-market approval, then they would be protected by preemption, subject only to “parallel claims” that the manufacturer somehow violated relevant FDA regulations.  We are assuming, perhaps incorrectly, the continuity of the current preemption regime for medical devices.

Second, what happens to the learned intermediary rule where the product itself – an autonomous surgical robot – stands in the shoes of the traditional learned intermediary?  Plaintiffs would, of course, give the same answer as always:  Abolish the rule as outdated.  We disagree.  Any consideration of the jurisprudential reasons for the learned intermediary rule, discussed here, suggests just the opposite.  The rule exists because patients can’t be expected to understand for themselves the complexities of prescription medical products, so the law demands that the scientific and technological information necessary to make intelligent use of these products be provided to trained, professional “learned intermediaries,” who are then expected to counsel their patients about individualized treatment decisions.

Does this rationale apply to autonomous surgical robots?  Absolutely.  These products will be some of the most advanced and complex medical technology yet produced, and the law cannot expect their manufacturers simply to provide patients with the instructions for use, tell them to “have at it” and make up their own minds.  More than ever, patients will need medical professionals to explain the risks, benefits, and alternatives of automated surgery.  Who, then, becomes the learned intermediary when the traditional role of the surgeon is performed by a “product” in a potential legal action?  Looking to the purposes of the learned intermediary rule, our answer, at this point, is whichever physician whose legal duty it is to conduct the informed consent discussion with the patient.  The learned intermediary rule exists in large part to ensure that the doctor who will be advising the patient has adequate information to do so.  The professional standard that the medical community ultimately adopts to handle informed consent in automated surgery is its own business.  But however the medical community resolves that issue, the duty of the robot manufacturer should be the same as ever:  to provide information about the product adequate to enable the learned intermediary to evaluate that information, along with the patient’s medical history, in order to make proper treatment decisions and to explain these decisions to the patient.

Third, what will the advent of autonomous surgical robots do to the legal distinction between “services” and “product sales” that has traditionally protected health care providers – including hospitals − from strict liability?  We don’t know.  The answer probably depends on how the medical community integrates these robots into the health care system generally.  If robotic surgery is carried out under the close supervision of medical professionals, then probably not much will change in terms of the sales/services distinction.  That has been the case with currently available robot-assisted surgery.  See Moll v. Intuitive Surgical, Inc., 2014 WL 1389652, at *4 (E.D. La. April 1, 2014) (robot use did not remove surgical claim from scope of malpractice statute).

However, if cost consciousness leads to “routine” automated surgery being conducted with only technicians on hand to ensure that the robots are functioning properly, then the entire exercise starts to look more like the use of a product than the provision of medical services. Once again, it will be up to the medical community to develop its standards of care for the use of autonomous surgical robots.  If necessary, the law will adapt.

A number of sources of potential liability associated with automated surgery, such as failure to detect an unexpected cancer,or a non-robot-related intra-operative complication (like an adverse reaction to anesthesia) would appear to implicate medical malpractice theories of liability (e.g. “lost chance”) rather than product liability.  How will courts handle claims at the intersection of medical malpractice and product liability − that, however good the robotic software is at its intended surgical use, it does not allow the robot to react to the unexpected like human surgeons can?

Fourth, in terms of product liability, what’s the “product?”  Here, we mean whether the software, including the MRIs, CAT scans and other patient imaging data, is considered something separate from the physical robot itself.  Is the software purchased, or provided, separately from the hardware that is the visible robot?  This distinction could make a big difference in available theories of liability.  It could also be important in determining component part liability in cases where the hardware and software manufacturers point fingers at one another.  In such cases, possible defendants include healthcare professionals, hospitals that maintain the robots, manufacturers of robotic hardware, and providers of software – both the software that runs the robot and patient-specific electronic scans.  As now, there is also the possibility that the patient may not follow proper instructions.  Will autonomous surgical robots be required to have aviation-style “black boxes” to provide post-accident information?

The prevailing view under current law has been that software is not a “product.”  “Courts have yet to extend products liability theories to bad software, computer viruses, or web sites with inadequate security or defective design.”  James A. Henderson, “Tort vs. Technology: Accommodating Disruptive Innovation,” 47 Ariz. St. L.J. 1145, 1165-66 n.135 (2015).  The current restatement defines a “product” as “tangible personal property.”  Restatement (Third) of Torts, Products Liability §19(a) (1998).  In a variety of contexts, software has not been considered “tangible.”  See 2005 UCC Revisions to §§2-105(1), 9-102; Uniform Computer Information Transactions Act §102(a)(33) (NCCUSL 2002); ClearCorrect Operating, LLC v. ITC, 810 F.3d 1283, 1290-94 (Fed. Cir. 2015); United States v. Aleynikov, 676 F.3d 71, 76-77 (2d Cir. 2012); Wilson v. Midway Games, Inc., 198 F. Supp.2d 167, 173 (D. Conn. 2002) (product liability case); Sanders v. Acclaim Entertainment, Inc., 188 F. Supp.2d 1264, 1278-79 (D. Colo. 2002) (product liability case).  However, a couple of cases have gone the other way.  Winter v. G.P. Putnam’s Sons, 938 F.2d 1033, 1036 (9th Cir. 1991) (dictum in case involving books); Corley v. Stryker Corp., 2014 WL 3375596 at *3-4 (Mag. W.D. La. May 27, 2014), adopted, 2014 WL 3125990 (W.D. La. July 3, 2014).  Also of possible note, a legally non-binding 2016 FDA draft guidance considers software to be a “medical device” subject to FDA regulation in situations that would probably include autonomous surgery.

The availability – or not – of strict liability could be a big deal in cases alleging injuries arising from fully automated surgery performed by autonomous surgical robots.  What caused the injury?  Was there a problem with the robot’s hardware (such as a blade or needle malfunction)?  Was the robot incorrectly maintained?  These issues would not implicate the robot’s software.  On the other hand, was there a defect in the surgical software’s algorithms (that is, a design defect)?  Was the software designed properly but somehow corrupted (that is, a manufacturing defect), or hacked (intervening cause).  Or, to introduce a different defendant, was there some sort of error in the electronic patient-imaging files that told the robot how to operate on this particular patient?

In strict liability, a “product” defect is the key element of liability (as is a “good” for warranty claims).  A product malfunction, in the absence of reasonable secondary causes, in many jurisdictions can establish a jury submissible case.  In negligence, the plaintiff must also prove breach of duty, and an accident is not generally considered probative of such a breach.  Res ipsa loquitur – the negligence version of circumstantial proof of defect – is almost unheard-of in the context of medical treatment.  If there is a “product,” then strict liability is available.  If there isn’t a “product,” the plaintiff is obliged to prove negligence.  This distinction can be important, given how difficult proof of defect is likely be.  Cf. Pohly v. Intuitive Surgical, Inc., 2017 WL 900760, at *2-3 (N.D. Cal. March 7, 2017) (rejecting theory that invisible “microcracks” caused burns during robot-assisted surgery).

These are the issues that jump out at us as we consider the possibility of autonomous surgical robots for the first time.  There are undoubtedly others.  The technological possibilities are amazing.  As defense lawyers, it is our job to ensure that these possibilities are realized, and are not put out of reach by excessive liability.

What follows is a guest post from long-time friend of the blog Thomas J. Hurney, Jr. of Jackson Kelly PLLC in Charleston, West Virginia.  Tom comes to us today with news of an interesting – and favorable – federal court remand denial in one of the recently filed opioid litigation in his state.  It raises interesting legal issues in the context of litigation where the possibility of local prejudice makes the right of removal to federal court extremely important.  As always with our guest posts, Tom is 100% responsible for what follows.  He thus deserves all the credit and any blame.


With respect (a lot) to the Drug & Device folks, removal and remand cases are pretty hard to spice up.  While these cases may cry out for humor and whimsy, this guest post with an old-school case summary will have to do the trick.

A number of governmental entities – states, counties and cities – have sued drug manufacturers, distributors, pharmacists and doctors, alleging that because of their distribution, sales and prescription practices, communities have been “flooded” with opioids, resulting in “an acute epidemic of drug use and related social problems.”  Relying on tort and nuisance theories, these governmental plaintiffs seek damages to “compensate … for sums [they] expended and will be forced to expend responding to social problems caused by the opioid epidemic.”

In County Commission of McDowell County v. McKesson Corp., ___ F. Supp.3d ___, 2017 WL 2843614 (S.D.W. Va. July 3, 2017), the County Commission sued several pharmaceutical distributors, including named-defendant McKesson, and added a local physician.  The defendant distributors were all citizens and residents of states other than West Virginia.  The defendant physician was a West Virginia resident, transparently added to destroy diversity jurisdiction, so that plaintiff McDowell County could sue in (you guessed it) McDowell County Circuit Court.

The defendants removed the action, alleging the physician was fraudulent joined, and also fraudulently mis-joined, to defeat diversity.  The defendants argued that the physician was fraudulently joined because there was no possible cause of action against him, as the plaintiffs failed to serve him with a Notice of Claim and Certificate of Merit at least thirty days before filing suit, as required by the West Virginia Medical Professional Liability Act, W.Va. Code §55-7B-6.  Because this failure required dismissal of the complaint against the doctor, there was no possible existing claim, so he was therefore fraudulently joined.

Defendants also argued fraudulently mis-joinder, because “the claims against [the physician] arise out of different transactions, involve different evidence, and rest on different legal theories than the claims against the diverse defendants.”

The Plaintiff moved for remand.

Remand was denied with a scholarly opinion that literally started at the beginning. Citing Chief Justice Marshall’s decision in Strawbridge v. Custiss, 7 U.S. (3 Cranch) 267 (1806), this to-be-published opinion reviewed the history of diversity jurisdiction, noting that “[t]he rule of complete diversity appears nowhere in the statute.” Although diversity jurisdiction has existed since the First Judiciary Act of 1789, it has “always been the subject of some controversy,” with the stated reasons for diversity jurisdiction including local prejudice and perhaps a desire to protect creditors from state legislation favorable to debtors.  “In the early days of the republic, at least in Virginia [of which West Virginia was a part before 1863], prejudice was palpable.  The state courts there were notoriously hostile to foreign merchants.”  As an example, state juries were permitted to deny interest on a debt judgment for a creditor, effectively removing the profit from the transaction.  Id. at *1.

The reference to “local prejudice” as a basis for diversity jurisdiction is telling, since McDowell Co. v. McKesson is precisely the type of litigation that, these days, highly likely to raise this concern, that being a local municipality suing in its home court seeking recovery of damages that would (among other things) be likely to reduce local jurors’ taxes.

Concerning the trend in federal courts against diversity jurisdiction, the opinion pointed out that “[i]n recent times, crowded federal dockets, a dearth of evidence showing the existence of state court prejudice, and continuing doubts about the utility of diversity jurisdiction have pushed federal courts in the direction of limiting it.”  Consciously bucking that trend, the decision defended the importance of diversity jurisdiction, stating

Nevertheless, Congress has created diversity jurisdiction and a litigant whose case comes within it has a right to be in federal court. As the Supreme Court has said:  “[T]he Federal courts may and should take such action as will defeat attempts to wrongfully deprive parties entitled to sue in the Federal courts of the protection of their rights in those tribunals.”  In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices and Prods. Liab. Litig., 2016 WL 7339811 at *3 fn.4 (D.S.C. Oct. 24, 2016) (quoting Alabama Great S. Ry. Co. v. Thompson, 200 U.S. 206, 218 (1906)).  Therefore, if diversity jurisdiction is to be assigned to oblivion, it is Congress, not the courts who should send it there.  Here, where the opioid epidemic is pervasive and egregious, there is at least a possibility of prejudice to the defendants at the hands of a jury drawn exclusively from the very county that is the plaintiff in this suit.  A federal jury casts a wider net and is drawn from a division composing several counties.  All may have an opioid problem, but not one that is specific to the plaintiff county.

Id. at *2.

Turning to the analysis of the defendants’ removal, the court provided a concise review of the fraudulent joinder and mis-joinder doctrines.  “Fraudulent joinder is applicable where a defendant seeking removal argues that other defendants were joined when there is no possible cause of action against those defendants or where the complaint pled fraudulent facts,” whereas “[f]raudulent misjoinder . . . is an assertion that claims against certain defendants, while provable, have no real connection to the claims against other defendants in the same action and were only included in order to defeat diversity jurisdiction and removal.”  Id. (citing Wyatt v. Charleston Area Med. Ctr., 651 F. Supp.2d 492, 496 (S.D.W. Va. 2009)).

Thus, “[i]n order to establish fraudulent joinder in a particular case, a removing defendant must show either (1) there is no possibility that the plaintiff can establish a cause of action against the removing defendant, or (2) that there has been outright fraud in plaintiff’s pleading of jurisdiction. Id. The claim against the doctor, therefore, requires remand “[i]f the plaintiff demonstrates a mere ‘glimmer of hope’ that its claim will succeed.  Id. at *3 (quoting Hartley v. CSX Transp., Inc., 187 F.3d 422, 424-26 (4th Cir. 1999)). However, “[t]his is the rare case that fits the ‘no possibility of recovery’ rubric.” Id.

The court agreed that the physician was fraudulently joined because McDowell County did not serve him with a notice of claim and screening certificate of merit at least 30 days before suing him as required by the Medical Professional Liability Act, W.Va. Code §55-7B-6 (MPLA).

West Virginia Code § 55-7B-6, imposes a series of procedural prerequisites for filing a medical malpractice claim.  The plaintiff, in such a case, is required, at least thirty days prior to filing suit, to service notice on the defendant of his intention to bring suit.  The notice must contain a ‘screening certificate of merit’ executed under oath by a qualified expert.’  If this requirement is not met, the case must be dismissed.

Id.  The MPLA plainly applied to the allegations of improper prescription by the doctor – “[i]t can hardly be questioned that writing prescriptions for controlled medication are acts done within the context of rendering health care services,” as defined in the MPLA.  Id.

Finding that state law requiring pre-suit requirements are jurisdictional (citing Flagg v. Stryker Corp., 819 F.3d 132, 137-38 (5th Cir. 2016) (en banc) [ed. note, we blogged about Flagg here], and Robinson v. Mon, 2014 WL 4161965, at *8 (S.D.W. Va. Aug. 19, 2014)), the court concluded “there is no possibility of recovery by the plaintiff against [the doctor] in this civil action as it presently stands” and the dismissed the county’s claim against him without prejudice.  Id.

That was not all.  Aiming to prevent a recurrence of this kind of jurisdictional subterfuge (remember the “local prejudice” point), the court further found that the local prescribing physician was fraudulently mis-joined because the claims against him for improperly prescribing some opioids were attenuated from the claim that the distributors “flooded” the market.

Fraudulent joinder assumes that the claim against the nondiverse defendant is sufficiently related to the claims against the diverse defendant to have been properly joined in the same lawsuit.  Such is not the case with the related, but distinct, doctrine of fraudulent misjoinder.  Here, the inquiry is whether claims against the diverse and non-diverse defendants are sufficiently related to be properly joined in a single case.


Upon review of cases adopting misjoinder, the court found the Fourth Circuit has “not accepted nor rejected the doctrine” but noted several District Courts had done so (commending the reader to the list of cases in In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices and Prods. Liab. Litig., 2016 WL 7339811 at *3 fn.4 (D.S.C. Oct. 24, 2016)).  Id. at *4.  Since the propriety of joinder is a state law question, the court looked to Rule 20 of the West Virginia Rules of Civil Procedure, governing joinder, and cases on its federal counterpart.  “Under Federal Rule 20 and the corresponding West Virginia rule, the claims, to be properly joined, must (1) arise out of the same transaction or occurrence, and (2) present a question of law or fact common to all defendants.”  The court declined to apply a “heightened standard” similar to fraudulent joinder adopted in In re Lipitor (“[T]o establish fraudulent misjoinder, the removing party was required to show either outright fraud, or that there was no possibility that the plaintiff would be able to join the diverse and non-diverse claims”), instead finding “[t]he prevailing standard is whether there is a ‘reasonable possibility that a state court would find that [the plaintiffs’] claims against [one set of defendants] were properly joined with [the] claims against the other defendants.’” Id.

The court contrasted Wyatt v. Charleston Area Med. Ctr., a medical device case where the court found that product liability and malpractice claims arose “out of the same occurrence – the plaintiff’s surgery ‘and the after effects of that surgery,’” with Hughes v. Sears, Roebuck and Co., 2009 WL 2877424 (N.D.W. Va. Sept. 3, 2009), where the court found that the plaintiff, who fell off a treadmill, couldn’t combine product claims against the treadmill manufacturer with malpractice claims against the emergency room physician who misdiagnosed her injuries.  “[The emergency room doctor] had no control over the allegedly defective product.”  Id. at *5.

In the case before the court, there was no basis for a persuasive argument that the medical malpractice and products liability claims arose out of the same transaction or occurrence.  Moreover, “the evidence supporting these claims will be markedly different.”  Id.  McDowell County’s claims were more like Hughes than Wyatt, since:

 In this case, the connection, if any, between the actions of the corporate defendants, who allegedly flooded the market with opioids, and the doctor, who prescribed some of them, is far more attenuated than any connection between the manufacturers and seller of the treadmill in Hughes and the subsequent misdiagnosis by the treating physician.


Thus, the McDowell opinion concluded,

Since there is no possibility of recovery against [the doctor] in this case, he has been fraudulently joined. Additionally, the court finds no common questions of law or fact in plaintiff’s claims against the corporate defendants and the claims against [the doctor].  The cases against each are separate and distinct. Accordingly, [the doctor] has also been fraudulently misjoined. The Motion to Remand is therefore DENIED.  Since the court lacks jurisdiction over plaintiff’s claims against [the doctor] this action, insofar as it relates to [him], is dismissed without prejudice.


This remand ruling eliminates one possible jurisdictional ploy to defeat diversity. There are, however, others, and we will have to see what happens next.

The warranty is “express.”

Before you say, “Well, duh,” this sometimes actually does matter. Here’s how.

Most complaints in product liability actions involving prescription medical products that include express warranty counts do so as one of a bunch of different causes of action, all pleaded seriatim (“one after another,” in non-lawyer speak).  Believe it or not, lawyers get tired of repeating themselves – especially those (like our adversaries) who don’t bill by the hour.  Thus, in complaints, we usually see each cause of action in multi-count complaints begin with a paragraph “incorporating by reference” facts that were pleaded earlier in the document.

That can be fatal to express warranty claims – because the warranty must be “express” – whereas other claims, such as failure to warn, can be maintained on the basis of allegedly omitted facts.  Thus, incorporation by reference (or pleaded facts) that only incorporates allegations of omitted facts isn’t enough to plead express warranty.  This is one more way to make express warranty claims go bye-bye (see our TwIqbal cheat sheet for others), and it appears that, increasingly, plaintiffs have been called out for this failing.

The only appellate prescription medical product case that we’ve seen on this point is Rite Aid Corp. v. Levy-Gray, 876 A.2d 115 (Md. App. 2005), aff’d on other grounds, 894 A.2d 563 (Md. 2006).  In Levy-Gray, an omission by the defendant pharmacist of a statement in the manufacturer’s labeling didn’t cut it as a basis for express warranty:

[I]n order to have an express warranty there must be an affirmative statement of fact by the seller about the goods.  A claim that there is a warranty by omission is at odds with the UCC definition of an express warranty.  Here, the manufacturer’s package insert . . . contained, inter alia, the following statement:  [statement omitted]  The omission of this statement, which was relevant to the negligence claim asserted by Plaintiff, and is of some relevance to the medical causation issues, is not relevant to the creation of an express warranty.

Id. at 126 (citation omitted) (emphasis added).

Several federal district courts have made the same point.  The issue arose in the Testosterone MDL, where the “plaintiffs have pointed to no statement that constitutes an express warranty.”  In re Testosterone Replacement Therapy Products Liability Litigation, 2014 WL 7365872, at *8 (N.D. Ill. Dec. 23, 2014).  “[P]laintiffs must plead more than misstatements and omissions to state a claim for breach of express warranty.”  Rather, plaintiff “must point to a specific affirmation or promise.”  Id.  In Young v. Bristol-Myers Squibb Co., 2017 WL 706320 (N.D. Miss. Feb. 22, 2017), the court raised the issue sua sponte (meaning “on its own”), pointing out:

[T]he Court notes that, while not raised by the defendants, [plaintiff’s] breach of express warranty claim must fail to the extent it is based on alleged omissions in [the drug’s] prescribing information. An omission is neither an affirmation of fact nor a promise.

Id. at *15 n.10 (citation omitted).

Non-express “express” warranty claims also failed in House v. Bristol-Myers Squibb Co., 2017 WL 55876 (W.D. Ky. Jan. 4, 2017), because allegations of omissions were insufficient:

[Plaintiff] cannot base her express warranty claim on allegations that the Prescribing Information fails to include the “true risks” of the drugs and does not contain “adequate information[.]”  An express warranty is created by an “affirmation of fact or promise,” not an omission.

Id. at *6 (citations omitted).  In Vakil v. Merck & Co., 2016 WL 7175638 (D.N.J. Dec. 7, 2016), the court disposed of a warranty claim under Virginia law (significant because Virginia doesn’t have strict liability) observing that “during oral argument” plaintiff “indicated that his theory was more akin to an omission. Therefore, summary judgment is granted to Defendants as to the breach of express warranty claim.”  Id. at *5.

We also looked outside the drug/device sphere, and were surprised by the relative paucity of precedent.  Either plaintiffs aren’t pleading omissions in express warranty claims or defendants are letting them get away with it.  There’s one citable appellate decision, and it’s almost 30 years old.  Sidco Products Marketing, Inc. v. Gulf Oil Corp., 858 F.2d 1095, 1099 (5th Cir. 1988) (“Omissions, however, are not affirmative representations of any sort and thus cannot support a warranty claim, because express warranties must be explicit.”) (applying Texas law).  Young cited Sidco.  So did the next two cases – coincidentally, both from Missouri:

Plaintiffs repeatedly allege that the press releases and advertisements all failed to disclose the defect, so, to the extent their express warranty claims are based on advertisements and promotional materials, these claims are based on omissions. A breach of express warranty claim, however, cannot be premised on an omission.

In re General Motors Corp. Anti-Lock Brake Products Liability Litigation, 966 F. Supp. 1525, 1531 (E.D. Mo. 1997), aff’d on other grounds, 172 F.3d 623 (8th Cir. 1999)

Plaintiff, therefore, bases liability not on what the documents provide, but on what they do not provide.  The law is clear that [plaintiff] may not recover under this theory because omissions are not affirmative representations of any sort and thus cannot support a warranty claim, because express warranties must be explicit.

Cambridge Engineering, Inc. v. Robertshaw Controls Co., 966 F. Supp. 1509, 1524 (E.D. Mo. 1997) (quoting Sidco).

Likewise, defendants in tobacco product liability cases have not allowed plaintiffs to pass off “warranty by omission” as an “express warranty.”  Witherspoon v. Philip Morris, Inc., 964 F. Supp. 455, 465 (D.D.C. 1997).  Omissions of this and that are “at odds with the definition of express warranty.  Plaintiff has not pleaded an express promise on the part of Defendant.”  Id.  Accord Hughes v. Tobacco Institute, 2000 WL 34004261, at *10 (E.D. Tex. May 5, 2000) (“nondisclosure . . . does not create an express warranty”), aff’d on other grounds, 278 F.3d 417 (5th Cir. 2001).

Another appellate decision actually exists, but it’s non-citable:

Essentially, [plaintiff] bases his claim not upon an express affirmation of fact or description of the goods, but instead, upon the omission of language such as simulated or imitation.  [Plaintiff] has presented no authority that an omission of fact can create an express warranty.

Pocino v. Jostens, Inc., 2006 WL 1163785, at *5 (Cal. App. May 3, 2006).

Finally, we found one other case, on point, not citing anything beyond the relevant UCC section, but reaching the same result:  “[A] failure to include information in the specification sheet is the exact opposite of an express warranty.”  “[O]missions . . . are simply insufficient to support a breach of warranty.”  Cannon Technologies, Inc. v. Sensus Metering Systems, Inc., 734 F. Supp.2d 753, 769-70 (D. Minn. 2010).

Express warranty claims deserve attention in prescription medical product liability litigation.  Some courts allow such claims to escape preemption.  Others give express warranty claims a longer (or at least different) statute of limitations.  Such claims should not be allowed to persist when there is no basis for them, so any express warranty claim based on omissions should be challenged at the first opportunity.