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.

Id.

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.

Id.

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.

Id.

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.

The court may have taken a relaxed approach, but its decision has done nothing but raise blood pressures over at that DDL blog. The course of the Accutane litigation in New Jersey has been labored and we’ve posted about the whole journey. For years, we were pretty riled up. The news from the coordinated proceeding in the trial court had been very bad, including a few large plaintiff verdicts. Then the litigation got reassigned and under new management the tide began to turn. We could feel our pulse returning to normal. The new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. Indeed, the Appellate Division has vacated at least a half dozen plaintiff verdicts. After so many tortuous years, defendants in the New Jersey Accutane litigation finally had a reason to smile (actually thousands of reasons if reasons are dismissals). So we definitively can say we were unpleasantly surprised when last week the Appellate Division reversed the trial court’s order excluding certain plaintiff causation expert witnesses resulting in reviving over 2000 cases.

The to-be-published decision can currently be found at In re Accutane Litigation, 2017 N.J. Super. LEXIS 116 (App. Div. Jul. 28, 2017). It’s a long opinion with a lengthy discussion of epidemiology in general and the epidemiologic evidence pertaining to Accutane specifically. We’ll try to just hit the relevant highlights.

First a quick primer on New Jersey law on the admissibility of expert evidence. New Jersey has adopted a “relaxed” general acceptance standard for toxic tort and pharmaceutical cases. See Rubanick v. Witco Chemical Corp., 125 N.J. 421, 449 (1991). That means that if the expert’s theory is not generally accepted, it may still be admissible if it is “based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.” In re Accutane, at *47. Further, specifically in regard to reliance on epidemiology as evidence of causation, the court must address not just methodology but also the expert’s reasoning in applying or relying on that methodology to reach his/her conclusions. Id. The court should not only review the studies and other information to determine if they are the type of data experts ordinarily rely on but also “examine the manner in which experts reason from the studies and other information to a conclusion.” Id. at *51.

As we mentioned, the litigation has been handled by two different trial judges. The first judge allowed the opinions of plaintiffs’ experts based on the same type of evidence relied on by plaintiffs’ experts here. Id. at *5. But this litigation has been pending for 14 years. The science has not been stagnant during that time. From 2003 to 2009, there were no epidemiological studies regarding Accutane and irritable bowel disease (IBD) or Crohn’s disease. Id. at *8. Epidemiological studies are considered at the top of the scientific hierarchy. Experimental studies (double-blind randomized control trials) are the gold standard and observational studies (case-control or cohort studies) are the next best available evidence. Without those, plaintiffs’ experts were permitted to rely on “animal studies, human clinical studies, case reports, class effects, published scientific literature, causality assessments, and biological plausibility.” Id. In other words, they were permitted to use less reliable evidence because that is all there was.

But in 2009 and 2010, the first epidemiological studies were published – both of which found no statistically significant increased risk for developing Crohn’s disease from the use of Accutane. Id. Six more epidemiological studies followed and while the results vary, “with one exception, none of them demonstrates a statistically significant increased risk of developing Crohn’s disease.” Id. at *9. Despite the evolving state of the science, plaintiffs’ experts chose to discount the epidemiology in favor of the “other information” on which they had previously relied.

Applying even the New Jersey “relaxed” standard, the trial court found that plaintiffs’ experts reasoning and methodology “slanted away from objective science and in the direction of advocacy.” Id. at *53-54. After reviewing the evidence and conducting a full Kemp hearing (New Jersey’s version of a Daubert hearing), the trial court concluded that the epidemiologic evidence did not support a reasonable inference of a causal link between Accutane and Crohn’s disease. Plaintiff’s experts ignored the studies’ authors own conclusions, excluded the larger population based studies, and made assumptions to “bridge an analytical gap in his methodology.” Id. at *54-55.

We’ve blogged before about the risk of allowing litigation to march ahead of science. As the United States Supreme Court explained in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the goal of “reaching a quick, final, and binding legal judgment” on matters that are “often of great consequence” is not advanced by accepting hypotheses and conjectures in the place of reliable scientific evidence. But that is exactly what the New Jersey Appellate Division seems determined to do. The court announced its guiding principle as the antithesis of Daubert: “legal decision making in toxic tort and similar cases may vary from scientific decision making.”  Id. at *69. This doesn’t even reconcile with the New Jersey standard that requires general acceptance in the scientific community of an expert’s methodology and reasoning.

And what happens when “legal decision making” supplants the scientific process? Experts get to do things differently in the courtroom than in practice. They can ignore big epidemiologic studies not finding a statistically significant relationship for little ones that do, as long as they come up with some critique of the larger studies that lets them.  They can use data further down the “hierarchy” even though top tier evidence is against them.  They can rely upon their clinical experience in deciding what evidence accords with it. Precisely the types of things Daubert, Rubanick, and Kemp say should not be permitted.

Further, while giving lip service to the fact that “science is constantly evolving” and that “legal decisions need to be made based on the best evidence available at the time of the decision” – the court seems to be mired in the past. Id. at *69. It concludes that despite the overwhelming epidemiological evidence that demonstrates no statistically significant increase in the risk of Crohn’s disease from taking Accutane, plaintiffs’ experts can continue to rely on “other types” of evidence – “which in this same MCL docket they were previously permitted to use.” Id. at *70. Why is that part of the equation? As much as litigation shouldn’t lead science, it shouldn’t lag it either. It should move with it. The state of the science is vastly different than it was 14 years ago, and the court seems to be willing to overlook those developments. The opinion states that the decision “must be viewed in the context of this particular MCL litigation” and “concern[s] the survival of plaintiffs’ cause of action in the face of new scientific information.” Id. at *68-69. Exactly. Plaintiffs’ claims need to be assessed on the basis of the new scientific evidence. And if the claims can no longer survive based on the evolving scientific evidence, then that is the result. Ultimately, however, what seemed to matter more than accurately applying the law to the current state of the science, was “[t]he opportunity of thousands of plaintiffs, claiming injury from Accutane, to have their day in court.” Id. at *69.


Last week, we summarized PhRMA’s comments on the FDA’s proposed amendments to regulations regarding “intended uses.”  PhRMA showed how the FDA’s insistence that it could read manufacturer’s minds about intended uses made no sense on an evidentiary basis and ran afoul of First Amendment considerations.  Today, we’ll tip our cyber caps to the Advanced Medical Technology Association (AdvaMed), which also issued well thought-out comments on the FDA’s proposal.  You can read the AdvaMed July 18, 2017 comments here

 

To begin with, the AdvaMed letter excels at doing that thing that judges yell at dumb litigators for not doing in their motions — stating what relief is sought.  AdvaMed puts it plainly: “FDA should abandon the Final Rule and instead return to its original and unambiguous proposal to remove the reference to ‘knowledge’ as set forth in FDA’s September 25, 2015 proposed rule regarding the definition of ‘intended uses.’”  What’s wrong with the FDA’s proposed rule?  It’s bad in its totality, including its reliance the “totality of the evidence” standard.  AdvaMed correctly states that “the ‘totality of the evidence’ standard is more outcome determinative than prescriptive.”  We are reminded of how Justice Black called judicial balancing tests pretentious cover-ups for courts doing whatever they felt like doing.  A totality of the evidence test would mean that the FDA would administer rough justice on a case-by-case basis, sans principle and sans predictability. 

 

That lack of predictability is particularly pernicious where the chilled communications are so critical to public health.  AdvaMed provides concrete examples of communications pertaining to both approved and unapproved medical devices that any right-minded person (and any person who thinks they might someday benefit from advanced drugs and devices – that is, everyone) would favor.  Such communications include training and technical support, educational meetings about clinical trials and development data, feedback from doctors on investigational development, information about real-world experiences with devices, and engagement with health care professionals on device innovation and improvement.  Plaintiff lawyers love to say that drug and device manufacturers have a duty to be the foremost experts on their own products.  The communications potentially chilled by the FDA’s vague, overbroad content-less regulation on “intended uses” are all necessary to facilitate such expertise.        

 

AdvaMed makes the same constitutional argument that PhRMA made, though with some different wrinkles.  AdvaMed discusses the Washington Legal Foundation case from 1998.  The FDA, which raps companies on the knuckles if they are poor at signal detection, should have seen that 1998 case as a very clear signal that its chokehold on truthful off-label communications was unconstitutional.  AdvaMed also does a fine job of applying the Central Hudson requirement that regulation of commercial speech must be narrowly-tailored to serve the governmental interest.   In its request for comments on the proposed rule, the FDA supplied examples of speech restrictions that mostly related to “activities and communications involving the distribution or promotion of illicit drugs.”  There are already non-speech sanctions (including the Controlled Substances act, as well as mail or wire fraud statutes) available to address such criminal activity. 

 

For one brief moment of lucidity, the FDA recognized that a manufacturer’s knowledge that a third party was using a product off-label was not the same thing as the manufacturer’s intent that such product be used off-label.  Then the FDA reversed field, and now we have this new proposed rule.  AdvaMed makes clear that “it is inappropriate to hold manufacturers responsible for the use of their products by third parties over whom they have no control.”  Fairness says as much.  So does a concern for unintended consequences.  The FDA has more than once acknowledged that collaboration between manufacturers and health care practitioners is essential to help develop new life-enhancing or –saving products.  But if manufacturers will be put on the hook for everything they know such collaborators are doing, how can the nature or frequency of such collaboration be unaffected?      

 

AdvaMed concludes its comments with a request that, if the FDA won’t do the right thing and completely back off its wrong-headed “totality of the evidence” test, it should at least issue three clarifications of what would NOT show an intended use: (1) legitimate scientific exchange, (2) truthful, nonmisleading communications, and (3) mere knowledge of third party unapproved uses.  In short, the AdvaMed comments are everything the FDA’s proposed rule is not: clear, fair, and protective of speech and scientific development.   

 

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.

One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end. Such was an evening last week when we journeyed to New York to celebrate the birthday of the Drug and Device Law Rock Climber, now a waxing college senior completing a summer internship at an insanely cool company in Lower Manhattan.  We were treated to a tour of the office and to the comments that colleagues and mentors reserve for interns’ mothers.  We had perfect saltimbocca at a beloved Italian bistro.  We saw Waitress (again – we love this show).  We stayed overnight on the Climber’s couch, joined at some point by a four-pound Chihuahua.  And we relished every moment with this child-now-adult.  We were awash in happiness for the entire train ride home.

We were also happy (yet another suspect segue) with the court’s evidentiary rulings in today’s case, but decidedly not with the case’s very sad facts—an all-too-frequent dichotomy in our line of work. Because we spend vast amounts of our professional time struggling to achieve the exclusion of plaintiffs’ causation experts, we are always pleased to read a Daubert opinion that layers tidy analytical segments to reach a satisfying conclusion that correctly applies the Rules of Evidence and controlling case law.

In Smith v. Terumo Cardiovascular Systems Corp., et al., 2017 U.S. Dist. LEXIS 108205 (D. Utah July 12, 2017), the plaintiff’s decedent underwent open-heart surgery in which a heart-lung machine was used to circulate oxygenated blood through the patient’s body while his heart was being repaired.  At some point during the surgery, the machine stopped working for approximately ten minutes.  The plaintiff’s decedent never left the hospital after the surgery.  Eleven months later, he suffered a heart attack and died.

The plaintiff sued the hospital and the heart-lung machine’s manufacturer, asserting the usual claims. She hired a cardiologist as her causation expert, and he opined that the malfunction of the heart-lung machine caused the decedent to suffer physical and mental deterioration and ultimately caused his heart attack and his death.  The defendants moved to exclude the expert’s testimony, arguing that: 1) his causation opinions were unhelpful and unreliable; 2) he was not qualified to opine on neurological injuries; and 3) he should not be allowed “to provide a narrative of events that can and should be provided by other witnesses and records.” Smith, 2017 U.S. Dist. LEXIS 108205 at *5 (citation omitted).

Explaining that , “to be helpful, [the expert’s] opinion . . . that the . . . surgery and related complications had any causal . . . relationship to Mr. Smith’s injuries and ultimate death must be based on a ‘valid scientific connection,’ the court held that that the expert’s own deposition testimony demonstrated that his opinion would not be helpful to a jury. To wit, in his deposition, the expert admitted that he could not testify with certainty that there was a connection “between the surgery, the ten-minute lack of flow, and the heart attack that caused” the decedent’s death. Id. at *10-11 (citations omitted).   Instead, he could only go as far as concluding that “the events that happened at the time of surgery simply made it more likely” that the decedent would die as the result of a heart attack, although the decedent’s own risk factors –hypertension, smoking, diabetes, family history – were generally considered to be “the main contributors” to the development of the plaque that narrowed the decedent’s arteries and caused his myocardial infarction.  As such, the expert concluded, “[While] I think that what happened . . . played a role in his having a heart attack and made it less likely that he would survive a heart attack, but I cannot say that it caused his heart attack.Id. at *11-12 (emphasis in original, citation omitted).

While this is refreshing (and uncommon) candor for a plaintiff’s expert, it is obviously not “helpful” to the establishment of causation. Moreover, the court held, even if the testimony had been helpful, it was not reliable, because the expert did not “provide a basis to conclude that the relationship [was] causal and not merely corollary,” leaving too large a gap between his premise and conclusion, and because he failed to account for obvious alternative explanations for the decedent’s death.   Id. at *15-16.

The expert also concluded, contrary to the results of the decedent’s autopsy, that the decedent had suffered an earlier heart attack, around the time of the surgery, before the one that ultimately killed him eleven months later. The court held that this opinion was also inadmissible because the expert’s diagnostic methods were not generally accepted.  As such, the court concluded, “To allow the jury to hear [the expert’s] opinion on this point would be to allow the jury to hear conclusions based on inferior diagnostic metrics.  This will not be permitted.” Id. at *20.

Next, the court addressed the expert’s opinion that the decedent “suffered an injury to the brain due to prolonged lack of oxygenated blood flow to the brain.” Id. at *20-21.  The court held that the expert lacked the “knowledge, skill, training, or education that would qualify him to diagnose neurologic injuries.” Id. at 21 (internal punctuation and citation omitted).  Moreover, the opinion lacked any scientific basis, as the autopsy revealed no sign of hypoxic encephalopathy.   The court concluded, “[The expert] is not being as careful as he would be in his regular professional work outside his paid litigation consulting.  A jury has no use for [this type of speculation], especially from someone whose expertise lies elsewhere.” Id. at *24.

The court did not exclude the expert’s entire report, permitting him to testify that the decedent’s heart was injured during his surgery and to indicate what he relied upon to form his opinions. It held, however, that the expert would not be permitted “to give a general narrative of Mr. Smith’s health before, during, and after the surgery.” Id.

We like this opinion. It draws the correct lines, and it does so in clear and logical fashion.  It also reinforces the oft-apparent conclusion that plaintiffs’ lawyers disserve their clients when they hire the wrong people, and pay them to say the wrong things, in their quests for big settlement paychecks.   We will continue to keep you posted on judges who properly bar the courtroom doors against such experts, and those who don’t.

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

There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is – what’s left to be done? That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions. There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you’ve made progress in the MDL, you certainly don’t want to lose momentum post-remand.

Which was likely the thinking of defendants in Walker v. Ethicon, Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, plaintiff served an expert report from Dr. Shull, a gynecologic surgeon. Dr. Shull had previously been challenged by defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts – in defendants’ favor. Defendant here asked the court to apply those rulings. Generally speaking the remand court found plaintiff offered no justification not to.

First up was the expert’s opinion that different surgical procedures – ones not involving the use of the product — were safer alternatives to the defendant’s mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an “alternative design” for the product, the mesh MDL court had so held in another case. Id. The remand court agreed. The remand court also considered the impact of Illinois state law because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. Plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id. But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. Plaintiffs offered no support for interpreting “safer alternative design” in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of plaintiff’s claims. Without relevance, the testimony was excluded. Id. at *8.

Next were the doctor’s opinion on the duties of medical device manufacturers – testing, pharmacovigilance, and training. The court excluded them all. Defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor’s qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court. On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to defendants’ motion, the MDL court had also ruled that an expert “may not offer testimony that is solely a conduit for corporate information.” Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide “specific content or context.” Id. at *11.

Applying those rulings to the specific case, the remand court found that defendants had properly challenged Dr. Shull’s qualifications with enough specificity and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull “is not qualified to testify regarding the standard of care for medical device testing.” Id. at *13. Plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing defendants did or did not do – the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents – don’t need the expert for that. Id.

Plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems defendants should have been using just that what they were doing was “woefully inadequate.” The court found this was a “distinction without a difference.” Id. at *14-15. Dr. Shull’s experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And, again if he planned to talk generally about adverse events, that’s company documents and not an area for expert testimony.

Finally, Dr. Shull’s report included an opinion on whether defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the Instructions for Use for the product – and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That’s it.

We’re not sure what remains in Dr. Shull’s report, but we certainly agree that the above portions were appropriately trimmed away.

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”)

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. The tortured path of this ‘logic’ should, by itself, render this off-label regulatory regime questionable, but the FDA’s recent reaffirmance of it amounts to incoherent defiance.

The FDA takes the position that a company’s truthful, non-misleading statements about off-label use can constitute evidence of an intended use outside the label.  Even while acknowledging that off-label use can be absolutely necessary for some maladies, and even while getting repeatedly clobbered by courts holding that truthful, non-misleading communications about off-label use are protected by the First Amendment, the FDA stubbornly asserts the power to clamp down on such speech.

The FDA’s effort to keep its clamp-down power has been clumsy.  In 2015, the FDA proposed a rule regarding the scope of intended use.  (We have been covering this issue all along. For example, here is a 2015 post by Bexis discussing how the FDA tip-toed into this area, hiding the off-label issue in a notice ostensibly about cigarettes.  Good idea.  After all, in the eyes of the anti-tobacco crowd, the First Amendment hardly exists for some companies.)  One silver lining in the FDA’s proposed rule was that the FDA would “not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.”  What a refreshing and rare connection to fairness and reality! It did not last. In the Final Rule published earlier this year, the FDA insists on its right to consider evidence of mere knowledge of off-label use as part of a dreaded “totality of the evidence” standard.  Let the chilling commence.

But the effective date of this misguided Final Rule has been postponed until March 19, 2018.  In the meantime, interested parties may comment.  An extraordinarily thoughtful comment comes from the PhRMA organization, which represents pharmaceutical manufacturers.  Perhaps some will resist reading PhRMA’s July 18, 2017 letter with objectivity, being biased about alleged bias, but you can read it here.  You can see for yourself how the FDA’s not-so Final Rule runs counter to reality and the rule of law.

Here, in summary, are PhRMA’s main points:

1.  FDA cannot establish an intended use absent an external statement by the manufacturer about that use.

The PhRMA letter does a nice job of marshaling precedent and historical practice to prove that the intended use of a product “can be manifested only if the manufacturer conveys that intent to someone who is in a position to buy” the product.  Without that limiting principle, the FDA could attempt to establish a broader intended use via various internal communications.  This is a concern we feel acutely when defending our clients against private party litigations.  One reason that discovery is so ludicrously expensive and burdensome is that plaintiffs want to collect every internal document mentioning the product at issue, looking for some stray someone at sometime saying something that sounds bad, even though it does not represent a final position, or the position of the company at all. Mind-reading is a fool’s errand.  The only reliable evidence is what the company actually said and did in terms of persuading others how to use its products.  Forest Gump might say that ‘off-label is as off-label does.’  A more limited approach focusing on external statements makes sense, serves fairness and judicial economy and, perhaps most important, is fully supported by cases going back at least as far as 1920, ranging to include foods, drugs, and tobacco. For example, in American Health Prods. Co. v. Hayes, 574 F. Supp. 1498, 1505 (S.D.N.Y. 1983), the court read the term “intended” to refer to specific marketing representations.  The PhRMA letter cites several other cases, and offers a compelling argument for a circumscribed interpretation of intended use – one based on reality rather than cynicism and innuendo.  Even aside from the FDA regulatory issue, we wonder whether PhRMA’s argument might support our side in discovery disputes, or might assist us in drafting jury instructions where plaintiffs managed to smuggle allegations of off-label promotion into the case.

2.  Overly restrictive regulation of truthful, non-misleading communications to health care practitioners about unapproved uses violates the First and Fifth Amendments.

Over the last decade-plus, courts have been constantly reminding all of us, including the FDA, that the First Amendment protects commercial speech, and that truthful, non-misleading communications about off-label uses are included in such protection.  The hits just keep on coming.  Not to put too fine a point on it, the FDA’s position on off-label communications has been thoroughly undermined by recent cases.  The FDA’s exercise in wish-fulfillment simply cannot coexist with the SCOTUS opinion in Sorrell, which applied heightened scrutiny in striking down a law that restricted pharmaceutical manufacturer communications with healthcare professionals. The FDA’s “totality of the evidence” standard, besides being vague and overbroad, is certainly not the least restrictive means to protect the integrity of its drug approval process.  The Second Circuit’s Caronia decision directly refutes the FDA’s policing of truthful, non-misleading communications about off-label uses.  Apparently, all that the FDA can do in the face of Caronia is wish that it would go away.  The SDNY decision in Amarin is similarly fatal to the FDA’s position.  The PhRMA letter rips into the FDA’s efforts to prop up the proposed rule, laying waste to dicta and distinguishing away the few cases cited by the FDA.  If this debate was a little league game, it would be called on the basis of the slaughter rule.  But our concern is whether the FDA will dispassionately listen to the arguments and pay attention to the law.  In truth, we are not certain that the FDA will approach this issue with even the fairness we expect to get in a little league game.

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.