Reading through Obermeier v. Northwestern Memorial Hosp., __ N.E.3d __, 2019 IL App. (1st) 170553 (Ill. App. Div. June 28, 2019), reminded us of scrolling through television channels in the middle of the day with time to kill. The opinion started off talking about the basic medical facts of the case and we were ready to buzz as our litigation memory twinged with talk of the plaintiff’s regurgitant and prolapsed mitral valve being repaired with an annuloplasty ring back in 2006. The manufacturer of the ring–named after a pioneer in heart valves—was sued, but won summary judgment before trial. As the evidence at trial against the implanting surgeon and hospital was recounted, we were reminded of those game shows where one player describes a person, place, or thing without using proscribed words. Later, as the trial evidence grew stranger and stranger, we thought of the old game shows where the contestant has to determine if an unidentified speaker’s self-description is made up and where actors improvise a scene based on seemingly disconnected prompts. At the end of the opinion—if not the end of the more than a decade long saga (or soap opera)—the defense verdict from trial was affirmed it looks like the good guys won.

As always, our focus is on the issues most relevant to drug and device law, even though there are some interesting evidentiary nuggets in the appellate court’s rulings. The claims pursued at trial against the implanting surgeon and the hospital alleged that plaintiff was injured by the lack of adequate informed consent with regard to the use of the particular annuloplasty ring, called the Myxo ring. Plaintiff contended that the consent was inadequate because she was really in a secret clinical trial for an investigative device because the Myxo ring had not been cleared or approved at the time of surgery. Plaintiff did not contend that the ring was defective in its design or manufacture or that it malfunctioned. After the jury ruled in favor of the defendants, her appeal did not contend that the verdicts were unsupported by admitted evidence or that the trial court had erred in its jury instructions or verdict form. Rather, she contended that pre-trial rulings on motions to dismiss, motions for summary judgment, and motions in limine were in error. The discussion of actual trial evidence mostly provided context for why these rulings were correct or why any error was harmless.

Our somewhat condensed and reorganized summary of the trial evidence is as follows. Plaintiff’s mitral valve regurgitation progressed over the course of more than twenty years to the point where her cardiologist suggested surgery and referred her to a prominent cardiac surgeon, Dr. McCarthy, who agreed that surgery was indicated. He obtained informed consent from plaintiff for the repair of her mitral valve using a medical device called an annuloplasty ring, although which one of the different rings available at the hospital would be used was to be determined in surgery and the plaintiff was not presented with a list of options. Dr. McCarthy chose to use the Myxo ring because he thought it was the best choice for plaintiff. He had also invented the ring based on his view that a “pre-bent ring” would have advantages over existing devices that had to be bent as needed. He worked with the manufacturer to develop prototypes, which was something he had done previously for other annuloplasty rings. The manufacture was responsible for determining and following the regulatory pathway for the device, manufacturing it, and labeling it. By the time of plaintiff’s surgery, Dr. McCarthy considered the Myxo ring a marketed device and did not treat it like he did investigational devices. He and the hospital were familiar with clinical trials and investigational devices, but treated plaintiff’s surgery like clinical care outside of a clinical trial because the Myxo ring was not considered an investigational device. For instance, there was no Investigational Review Board (”IRB”) involvement, although plaintiff was included in a retrospective chart review and “Outcomes Registry.” (Dr. McCarthy published peer-reviewed papers on the Myxo ring, among other aspects of his repair of mitral valves.)

A representative of the manufacturer at trial testified the company did not treat the Myxo ring as an investigational device at the time of plaintiff’s surgery or have a clinical trial set up with Dr. McCarthy on the device. As a Class II device, the Myxo ring was evaluated by the company under the 1997 guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Based on its analysis, the company used a “Justification to File” for the device rather than submitting a 510(k) application (or something else) to FDA before initial marketing. The representative testified that Dr. McCarthy and the hospital were not parties to its decisions on the regulatory pathway for the device, but stood by them. (Although not discussed in the opinion, there was later interaction with FDA over this device and a subsequent 510(k) application was cleared.)

Plaintiff and the defendants presented dueling experts on whether plaintiff really was in a clinical trial on an investigational device according to FDA regulations and whether the sort of consent seen in clinical trials was required for plaintiff’s surgery. They did agree, however, that the manufacturer is responsible for determining the regulatory pathway for the product and that a surgeon does not have to investigate whether the right pathway has been followed. Plaintiff’s star witness, Dr. Rajmannan, had worked with Dr. McCarthy at the defendant hospital and maintained that there really was a clinical trial on an investigational device without appropriate consent or other measures being followed. She opined that plaintiff might have been injured by the ring pinching an artery or a suture being placed in an artery (as could happen with any annuloplasty). This is where things got interesting. Dr. Rajmannan, who appears to be a cardiologist by training, had no experience with cardiac surgery or any official role with an IRB. She did, however, complain to the hospital about the Myxo ring back in 2007, refuse to participate in the internal investigation, get suspended, and get fired from the hospital. Then she reported Dr. McCarthy to a state board, brought a qui tam action for damages against Dr. McCarthy, contact multiple media outlets, contact the Senate, contact the President, publish blog posts (!!!), and self-publish e-books. All of these apparently focused on advancing essentially the same theory that plaintiff claimed at trial about an improper clinical trial about an investigational device, as opposed to the clinical use of a marketed medical device that the surgeon and hospital assumed had followed the right regulatory path to market.

Stranger than fiction, but why are we posting on it? Buckman and the lack of a private cause of action for violation of FDA regulations, of course. After plaintiff lost with the jury, some of her appeal focused on the claims against the manufacturer. As an initial matter, her claims for battery against the manufacturer and for lack of consent and battery against the hospital were estopped because the jury had rejected that any inadequate consent had caused plaintiff any injury. There is a practice point in here about how plaintiff’s election to have a general verdict rather than detailed jury interrogatories worked against her on appeal. There is also a discussion of Illinois law on when a hospital owes a duty to get a patient’s consent, because the court went to the merits despite the estoppel. The battery claim against the hospital—remember from law school or the bar that battery is an intentional offensive contact without the consent of the other party—did not work because the plaintiff consented to the operation, including an operation that would use some annuloplasty ring, and the failure to specify the ring that would be used did not make it unauthorized. For the battery claim against the manufacturer, the plaintiff contended that it was responsible for “registering the Myxo ring with the FDA and for ensuring that it was properly cleared or approved by FDA,” such that the failure to do so made all subsequent uses a battery on the patient. A creative theory, but it was premised on a violation of the FDCA. The U.S. enforces FDCA violations under 21 U.S.C. § 337(a). And Buckman “conclusively determined that a private litigant may not sue a medical-device manufacturer for violating the FDCA.” Short and sweet.

After addressing whether the manufacturer could be liable under a strict liability theory if Dr. McCarthy was its agent—it cannot because, among other things, agency requires control—the court returned to Buckman. Plaintiff framed a failure to warn claim against the manufacturer based solely on the failure to disclose that the device was allegedly investigational and was on the market as a result of the violation of FDA regulations.

Plaintiff’s argument appears to be that. Regardless of whether the Myxo ring was defective in any way, Edwards had a duty to warn patients that it had not been properly cleared by the FDA. To allow plaintiff to recover on her failure to warn claim without any allegation that the Myxo ring was defective would amount to creating a cause of action for violation of the FDCA, which, as described above, is precluded under Buckman, 531 U.S. 341, 349 n.4 (2001).

Accordingly, summary judgment on that claim was affirmed.

The rest of the opinion concerns certain documents relating to peer review the court had held to be privileged and the court’s denial of certain motions in limine plaintiff filed on the cross of Dr. Rajmannan and Dr. McCarthy’s testimony about royalties. We will not discuss those rulings except to note that plaintiff’s contention that her star witness’s own history of allegations and statements did not go to bias fit right in with the wackiness of the facts of this case.


Judges should … judge. They should decide legal issues. But some judges think their primary role is to “manage” litigation. It turns out that such management often means strong-arming parties into settlement. Is that appropriate? We wondered about that. We wondered it aloud. We wondered it in the presence of one of our Summer associates, Catherine Houseman (Temple 2020). She came up with research that we thought was interesting, so we will now share it with you. (We have edited it very slightly, not to alter or improve the substance, but to add the flippant tone so many of you have to expect from us. Oh, and the screed at the end is entirely ours.)

I. Rule 16 and the Code of Conduct

Sometimes the judicial jaw-boning in favor of settlement begins as early as the Fed. R. Civ. P. 16 pretrial conference. But the Advisory Committee Notes on Rule 16 provide that the purpose of this provision is not to “impose settlement negotiations on unwilling litigants,” but rather “it is believed that providing a neutral forum for discussing [settlement] might foster it.”

According to the Code of Conduct for United States Judges Canon 3A(4), a judge “may encourage and seek to facilitate settlement but should not act in a manner that coerces any party into surrendering the right to have the controversy resolved by the courts.” Canon 3C(1) provides that a “judge shall disqualify himself or herself in a proceeding in which the judge’s impartiality might reasonably be questioned.” Further, Canon 4A specifies that a “judge should not act as an arbitrator or mediator or otherwise perform judicial functions apart from the judge’s official duties unless expressly authorized by law.”

In 2009, the Judicial Conference’s Committee on the Code of Conduct interpreted the Code’s settlement provision in an advisory opinion. The Committee noted that there is no per se impropriety in a judge’s participation in settlement discussions or in a judge’s conducting of a trial following his or her participation in settlement discussions. However, there are local rules in some jurisdictions that explicitly prohibit judges from handling both settlement talks and trials. See, e.g., D. Idaho. Civ. R. 16.4(b)(2)(B) (“As a general rule, the presiding judge assigned to the matter will not conduct the judicial settlement conference.”); W.D.N.C. Civ. R. 16.3(d)(3) (“[A]ny judicial officer of the district other than the judicial officer to whom the case is assigned for disposition may preside over a judicial settlement conference convened by the Court.”); M.D. Tenn. R. 16.04(a) (“Settlement conferences will ordinarily be conducted by a Magistrate Judge other than the Judge to whom the case is assigned.”). In the absence of a local rule, the Committee emphasized that whether ethical concerns arise in a particular proceeding depends on the specific nature of the judge’s actions and whether his or her impartiality is called into question. The Committee highlighted that ethical concerns are more likely to arise in nonjury trials, especially in instances where a judge probes the parties’ assessments of the value of the case, reviews their settlement offers and possibly suggests specific settlements amounts, and then tries the case and awards damages when settlement talks fail.

In conclusion, the Committee provided that while a “trial judge’s participation in settlement efforts is not inherently improper under the Code,” settlements must be “examined on a case-by-case basis to determine their ethical propriety.” Therefore, certain factors must be taken into account: whether the case will be tried by a judge or a jury, whether the parties themselves or only counsel are involved in settlement discussion, and whether parties have consented to settlement discussions or a subsequent trial by the same judge who presided over the settlement discussions.

II. Case Law

a. Bias

Title 28 of the U.S. Code section 455(a) provides that a judge shall disqualify himself or herself “in any proceeding in which his or her impartiality might reasonably be questioned.” A judge can disqualify himself or herself under this section sua sponte. Section 455(b), on the other hand, provides that a judge must recuse himself or herself where he or she “has a personal bias or prejudice concerning a party, or personal knowledge of disputed evidentiary facts concerning the proceeding.” Recusal under this subsection requires the filing of a motion.

In Johnson v. Trueblood, the Third Circuit determined whether a district court judge’s comments during settlement negotiations amounted to extrajudicial bias and justified his recusal. 629 F.2d 287, 291 (3d Cir. 1980) “Extrajudicial bias” refers to bias that is not derived from the evidence or conduct of the parties that the judge observes in the course of the proceedings. Id. at 291. In this case, the plaintiffs argued that the judge’s comments that the lawsuit was a “personal tragedy for the defendants” who were “honest men of good character” showed extrajudicial bias. In his opinion denying the motion to recuse, the judge asserted that his remarks were based on his perception of the case and were his attempt at getting the parties to settle. Id.

The Third Circuit determined that the judge’s comments at the settlement conference did not amount to extrajudicial bias. In making this determination, the court stated that the relevant inquiry was whether the judge’s pretrial comments were linked to his evaluation of the case based on the pleadings and other material outlining the nature of the case, or whether they were based on purely personal feelings towards the parties and the case. Id. Specifically, the court reasoned that his comments “may have been a form of judicial coloration in an overzealous effort to settle what obviously would be a lengthy and complicated case to try.” Id. The Third Circuit emphasized that while the “settlement fever” in this case was not enough to warrant recusal, judges “must not permit their role as negotiator to obscure their paramount duty to administer the law in a manner that is both fair in fact and has the appearance of fairness.” Id. at 292.

The Tenth Circuit expressed a similar caution in Franks v. Nimmo, where the trial judge attempted to persuade the plaintiff to accept the defendant’s settlement offer. 796 F.2d 1230 (10th Cir. 1986). Specifically, the judge privately met with the plaintiff and told him “these matters never work out for a plaintiff unless they are settled, and that he ought to settle because the judge could not rule in his favor.” Id. at 1233. The court found that the comments did not show any bias on behalf of the judge because his attempt to settle the case was “clearly beneficial” to the plaintiff. Id. at 1234.

There is a case out of the Seventh Circuit, Ghevas v. Ghosh, where the court reached a similar conclusion: “A judge may not coerce a party into settling. Coercion occurs when a judge threatens to penalize a party that refuses to settle. But a judge may encourage settlement, and he or she is not prohibited from expressing a negative opinion of a party’s claim during discussions as a means to foster an agreement.” 566 F.3d 717, 719-20 (7th Cir. 2009). See also Cantu v. U.S., 908 F.Supp.2d 146, 151 (D.D.C. 2012) (“[A] trial judge may convey his views about a settlement offer to the litigants’ counsel who are free to accept or reject the judge’s views, so long as the judge does not in any way bring pressure on the parties to settle.”).

b. Coercion

In Kothe v. Smith, the Second Circuit vacated the lower court’s judgment because the judge coerced the parties into settling. 771 F.2d 667 (2d Cir. 1985). The judge specifically recommended that the case be settled between a certain dollar amount and warned the parties that if they settled for a comparable figure after the trial had begun, he would impose sanctions—which he did. The court held that the judge’s conduct amounted to an abuse of discretion and observed: “[P]ressure tactics to coerce settlement simply are not permissible. The judge must not compel agreement by arbitrary use of his power and the attorney must not merely submit to a judge’s suggestion, though it be strongly urged. [Rule 16] was not designed as a means for clubbing the parties . . . into an involuntary compromise. Id. at 669.

In Goss Graphics Sys. v. Dev Indus., the Seventh Circuit reassigned a case to a different judge because the original judge dismissed the case when the plaintiff refused to settle. 267 F.3d 624 (7th Cir. 2001). The court highlighted, “if parties want to duke it out, that’s their privilege. Maybe the plaintiff was less than forthcoming in settlement negotiations than it should in some abstract sense have been, but that was its right.” Id. at 628. In another case, Cabrera v. Esso Std. Oil Co. P.R., the First Circuit concluded that the trial court abused its discretion by factoring the plaintiff’s refusal to settle into its decision to dismiss the case. 723 F.3d 82 (1st Cir. 2013). The court chastised the lower court for “permit[ing] the information gleaned through its involvement with the settlement talks to exert undue influence over its disposition of appellant’s motion.” Id. at 89. The court further noted that while the court’s desire to aid the settlement process was commendable, it became too involved in settlement discussions by obtaining information about the parties’ positions that unduly influenced its ruling. Id. at 90.

c. Jury Trial vs. Bench Trial

Another factor considered in determining whether a judge is too involved in settlement discussions is whether the case is a jury trial. In U.S. v. Pfizer, the Eighth Circuit reasoned that while a judge presiding over a jury trial may make settlement comments merely giving the parties his or her educated guess on the jury’s finding, a judge presiding over a bench trial who expresses his views on settlement may be guilty of prejudgment and bias. 560 F.2d 319 (8th Cir. 1977). The court reasoned that because of this difference, when the judge is the trier-of-fact, he or she should avoid recommending a settlement figure. 323.

Notably, a local rule in Texas explicitly prohibits the assigned judge from discussing settlement figures with the parties in bench trials without the express consent of the parties. N.D. Tex. R. 16.3(b).

III. Conclusion

What is our takeaway from this brief tour of the rules and the cases? The principles set forth by appellate courts are reasonably clear, even if enforcement of those principles can seem lax or erratic. Judges should resist the temptation to immerse themselves in details of settlement negotiations. That much seems obvious. What is, or should be, even more obvious, is that judges should not ignore or mangle their judicial duties in order to coerce settlement. We used to labor in front of a judge (many of you will know who we mean) who would constantly badger mass tort defendants to settle cases. If they settled cases, she would reward them by not scheduling trials for the next month or so. If they didn’t settle, she would line up the trials, creating a thoroughly unworkable schedule. Is that a dispensation of judicial grace or a form of coercion? To our eyes, it looks like the law as cat’s paw. It is also the sort of thing that virtually never gets scrutinized by any appellate court. Every day, in courthouses throughout the land, lawyers encounter settlement coercion. Maybe it happens when a judge tinkers with rulings, or the timing of rulings, to create an in terrorem effect that is designed to induce settlement. Pardon us if we do not applaud such “management.” Why can’t we get fair rulings, and let the parties decide whether settlement makes sense for them? We are entitled to expect justice, not coercion. We should not settle for less.

We are going to take today’s decision a little out of order because we think the outcome is fairly easily surmised from our title – plaintiff couldn’t sustain his claim because he didn’t have admissible expert testimony.  But before we get to the substance of the opinion, at the end the court was called on to decide plaintiff’s motion to re-open discovery to depose another doctor, presumably so plaintiff could try to get the needed expert testimony.  In support of the request, plaintiff’s counsel “blamed” their expert’s “attitude” and “his lack of preparation” for his deposition as the reason he was excluded.  Carrozza v. CVS Pharmacy, Inc., — F.Supp.3d–, 2019 WL 2913987, at *9 (D. Mass. Jul. 8, 2019).  Counsel tossed their own expert right under the bus.  That’s a worse excuse than “the dog ate my homework.”  It’s like saying “I ate my homework.”  Whose job was it to prepare the expert for his deposition?  To cross-examine him to make sure he knew how to handle himself in a deposition?  To review all the medical records and facts with him so that he was well-versed and his opinions fully supported?  Counsel.  It’s a poor excuse that says more about counsel than about the expert and it wasn’t reasonable grounds for re-opening discovery.

While that was the end of the decision, it was the start of plaintiff’s problems.  Plaintiff was prescribed levofloxacin, the generic equivalent of Levaquin, a quinolone antibiotic.  When the pharmacist went to fill the prescription, a “hardstop” warning in the pharmacy’s computer said that plaintiff was allergic to quinolone drugs.  But, when the pharmacist researched the “hardstop,” plaintiff’s patient profile showed other filled prescriptions for quinolone drugs and a denial from plaintiff that he had a quinolone allergy.  Based on this, the pharmacy’s policy is to allow the pharmacist to make the decision whether to fill the prescription.  Id. at *1-2.  Plaintiff got the medication and had an allergic reaction.  He developed rash symptoms that may have been a mild case of SJS.  Id. at *2.

Plaintiff had two experts.  He failed to timely serve the expert report from one and the expert was therefore excluded.  Id.  The expert report for the other, an allergist/immunologist, opined that the pharmacist had breached his standard of care and that the drug was the likely cause of plaintiff’s SJS.   Id.  But, at his deposition, the expert testified that he didn’t know the applicable standard of care for the pharmacist and didn’t know enough to be able to form an opinion as to whether plaintiff actually had SJS.  Id.  We guess this was the “lack of preparation” plaintiff’s counsel complained about.  More like a general lack of expertise.

If you want a full list of all the things plaintiff’s expert didn’t know, we refer you to the decision.  Id. at *3.  But, for a few highlights:  he had never diagnosed or treated SJS; he hadn’t read the medical records; he didn’t know plaintiff had been prescribed the drug before; and he didn’t know the standard of care for pharmacists in cases of “hardstops.”  Id.  Perhaps all things that should have been known before he was deposed – before he ever authored his report.

Not surprisingly, defendant moved to preclude plaintiff’s expert. After a thorough recitation of the Daubert standard, the court concluded

It is manifestly clear that [plaintiff’s expert] is not qualified to offer an expert opinion on either the appropriate standard of care for a pharmacist or whether [plaintiff’s] consumption of Levaquin caused his injuries, particularly the alleged SJS.

Id. at *5.  Plaintiff argued that this expert based his causation opinion on the precluded affidavit of plaintiff’s untimely expert, citing precedent that an expert is allowed to rely on otherwise inadmissible evidence if it is of the type commonly relied on in the field.  Id.  However,

A witness who has no relevant expertise or familiarity with a subject matter may not, [ ] simply parrot the conclusions of an expert who does. At a minimum, to allow such testimony would effectively permit a party to evade the disclosure requirements of Rule 26 and would preclude meaningful cross-examination.

Id.  Since the expert was simply speculating, he was excluded — leaving plaintiff with no expert testimony.  Which brings us to defendant’s motion for summary judgment which was largely based on the lack of expert testimony.  Plaintiff tried to argue that the main issue was a “common sense decision” whether to prescribe.  But, actually the question that had to be answered by the jury was whether the pharmacist had breached the standard of care when he decided to prescribe, a decision that involved professional and technical judgment beyond the lay experience of the jurors.  This is the first Massachusetts court to hold that expert testimony is required to support allegations of pharmacist malpractice.  Id. at *6.

Plaintiff had no expert on the appropriate standard of care, but he also had no expert evidence on causation.  So plaintiff also couldn’t prove the drug caused his injuries or that he actually suffered his alleged injuries.  Id.  That alone defeated all of plaintiff’s causes of action — negligence, products liability, and unfair trade.  But plaintiff’s products liability claim also failed under Massachusetts law for an independent reason.

In Massachusetts, the only products liability claim is one under the U.C.C. for breach of warranty.  But the U.C.C. only applies to contracts for the sale of goods.  Pharmacists do more than sell goods, they offer services.  And the court determined that since pharmacists predominately offer a service, the U.C.C. does not apply.  Id. at *7-8.  Plaintiff tried to save this claim by turning it into a failure to warn claim, but since that wasn’t alleged in the complaint he wasn’t allowed to raise it at summary judgment.  He also tried to turn it into a defective design claim – which would fail for lack of expert testimony and so was futile anyway.  Id. at *8.

This case was fraught with problems and the plaintiff’s counsel’s blame game may have been only one of them, but it was the worst in our eyes.

We might not have even read the Supreme Court’s recent – and long and convoluted − agency deference decision, Kisor v. Wilkie, ___ S. Ct. ___, 2019 WL 2605554 (U.S. June 26, 2019), except that it tripped several of our automatic searches by citing both Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  See Kisor, 2019 WL 2605554, at *5 n.2.  Kisor, after all, has nothing to do with prescription medical product liability litigation, it being an appeal from a denial of government benefits.

But Kisor cited Riegel and Mensing as part of a string citation for the proposition, “we have referred to that doctrine as Auer deference, and applied it often.”  Id.  Seeing the Court’s mention of two of our favorite preemption cases as examples of the application of agency deference also brought to mind the fact that the worst decision since the DDL Blog has been in existence − Wyeth v. Levine, 555 U.S. 555 (2009) – was also a prime example of the Court refusing to defer to the FDA’s position.

Because, in these three instances, preemption and agency deference had risen or fallen together, we decided to fight our way through Kisor, all 45 Westlaw headnotes and two concurring opinions of it.

The first thing that’s apparent to even a preemption neophyte is that this phenomenon of preemption and agency deference rising or falling together is not the view of the Court.  Several of the justices who are the most reliable supporters of tort preemption (Alito, Gorsuch, and Kavanaugh) are agency deference skeptics, while all of the justices who usually oppose tort preemption (Ginsburg, Breyer, Kagan, and Sotomayor) are proponents of agency deference.  Chief Justice Roberts likes both agency deference (in this context, anyway) and preemption, whereas Justice Thomas hates the former and is idiosyncratic on the latter.  So we have the liberal-conservative Supreme Court split working at cross purposes.

Indeed, it turns out that the Riegel and Mensing citations were not even in a part of the Kisor opinion that commanded a majority of the Court.  Part II-A did not have the Chief’s joinder.  It’s another example, like the recent Albrecht decision, of the anti-preemption side of the Court discussing preemption.  This section also uses an example of judicial deference to the FDA, but not (as might be expected) in a preemption context:

An FDA regulation gives pharmaceutical companies exclusive rights to drug products if they contain “no active moiety that has been approved by FDA in any other” new drug application.  Has a company created a new “active moiety” by joining a previously approved moiety to lysine through a non-ester covalent bond?

Kisor, 2019 WL 2605554, at *5 (citations omitted).  Primarily, this example is used (and cited elsewhere in the opinion) of an paradigm of the often recondite nature of agency regulation, which is advanced as a basis for having agency deference.  “If you are a judge, you probably have no idea of what the FDA’s rule means, or whether its policy is implicated when a previously approved moiety is connected to lysine through a non-ester covalent bond.”  Id. at *6.

Probably the core of Kisor – and a part that is a majority opinion − is its discussion of the hoops that courts must jump through before they can defer to an agency’s interpretation.  To the extent that preemption turns on agency deference, that’s a significant issue:

  • “[A] court should not afford Auer deference unless the regulation is genuinely ambiguous.”
  • “[B]efore concluding that a rule is genuinely ambiguous, a court must exhaust all the ‘traditional tools’ of construction.”
  • “[T]he agency’s reading must . . . be ‘reasonable.’”
  • “[A] court must make an independent inquiry into whether the character and context of the agency interpretation entitles it to controlling weight.”

Kisor, 2019 WL 2605554, at *8-9 (citations omitted).

One of the “important markers” for when agency deference is appropriate is something we have seen recently in the preemption context:

[T]he regulatory interpretation must be one actually made by the agency.  In other words, it must be the agency’s “authoritative” or “official position,” rather than any more ad hoc statement not reflecting the agency’s views. . . .  [T]he requirement of “authoritative” action must recognize a reality of bureaucratic life:  Not everything the agency does comes from, or is even in the name of, the Secretary. . . .  But there are limits.  The interpretation must at the least emanate from those actors, using those vehicles, understood to make authoritative policy in the relevant context.

Kisor, 2019 WL 2605554, at *9 (citations omitted).

Recall the “force of law” discussion in Albrecht only a couple months ago:

[T]he only agency actions that can determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’s congressionally delegated authority. . . .  Federal law permits the FDA to communicate its disapproval of a warning by means of notice-and-comment rulemaking setting forth labeling standards, by formally rejecting a warning label that would have been adequate under state law, or with other agency action carrying the force of law.  The question of disapproval “method” is not now before us . . . [but] whatever the means the FDA uses to exercise its authority, those means must lie within the scope of the authority Congress has lawfully delegated.

Albrecht, 139 S. Ct. at 1679 (citations omitted).

Reading these two analyses together, it seems like a variety of lesser FDA actions are now of questionable relevance.  Various FDA enforcement letters and all forms 483 are simply the view of one FDA official, and as we’ve pointed out, need not even be reviewed by an FDA legal officer before being issued.  They are owed no judicial deference, and thus have no basis being used in any preemption discussion – particularly as a basis for purported “parallel claims.”  The same would seem to be true of FDA guidance and “draft” guidance documents – unless an authoritative FDA decision with force of law happens to incorporate one.  That sometimes happens with final approval letters.

On the other hand, Citizen’s Petitions are a different animal.  Pursuant to 21 C.F.R. §10.30(e), such petitions must be decided by the “Commissioner.”  Actions on such petitions are considered “agency action” and published in the Federal Register.  Id. §§10.30(e)(2)(i), (e)(4).  They produce a formal “record.”  Id. § 10.30(i).  To the extent that both preemption and judicial deference depend on something being “authoritative” “official,” or “carrying force of law,” FDA responses to Citizen’s Petitions would seem to qualify.

Another interesting discussion is found in footnote 6 (also part of the Kisor majority opinion), concerning agency briefs.  The “general rule . . . is not to give deference to agency interpretations advanced for the first time in legal briefs.”  Kisor, 2019 WL 2605554, at *10 n.6.  But amicus curiae briefs are different.  Since an agency appearing as amicus is “not a party to the litigation . . . there [is] simply no reason to suspect that the interpretation [does] not reflect the agency’s fair and considered judgment.”  Id. (citations and quotation marks omitted).  This aspect of Kisor is significant because the FDA is often asked to provide views on preemption as an amicus.

Given the focus in Albrecht on “force of law” as a prerequisite to preemption, the discussion in Kisor (this part not an opinion of the Court) on “interpretive” agency rules is significant:

[T]he section allows agencies to issue “interpret[ive]” rules without notice and comment.  A key feature of those rules is that (unlike legislative rules) they are not supposed to have the force and effect of law. . . .  Instead, interpretive rules are meant only to advise the public of how the agency understands, and is likely to apply, its binding statutes and legislative rules. . . .  [I]nterpretive rules, even when given Auer deference, do not have the force of law.

Kisor, 2019 WL 2605554, at *12 (citations and quotation marks omitted).  We’re not administrative lawyers, so we don’t know the extent to which the FDA issues non-notice-and-comment rules, but to the extent the FDA does, Albrecht’s force-of-law discussion calls their preemptive effect into question.

Finally, the opinion of the court part of Kisor concludes with a paean to stare decisis, pointing out that the Court has employed deference to administrative agencies “dozens” of times, and other courts have “thousands” of times.  Id. at *13.  As mentioned at the outset, those instances include Riegel and Mensing.  We find this somewhat ironic, as four of the five justices joining in this part of the opinion, have refused – so far, at least − to accord Mensing the dignity of stare decisis.  Since “deference decisions are balls tossed into Congress’s court,” id. at *14, then perhaps the deference that the Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), gave to the FDA’s questionable interpretation (but through notice and comment rulemaking) of 21 U.S.C. §360k(a), should be reconsidered – given that Congress has since responded with the Safe Medical Devices Act that, as we discussed here, applies the same safety and effectiveness standards to both PMA and 510(k) devices.  We note, however, that as Chief Justice Roberts’ short concurrence points out (2019 WL 2605554, at *15), deference to agency statutory interpretations is governed by Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), and is not something that Kisor “touch[es] upon.”

We continue to scratch our heads over consumer class actions seeking monetary compensation when the customers received exactly what they paid for.  We see them from time to time in the pharmaceutical space, where patients claim monetary compensation even though the prescription drugs they used worked like they were supposed to with no adverse reactions.  That last point is worth repeating—no adverse reactions, as in no injury incurred or even alleged.  These kinds of money-for-nothing lawsuits often do not survive, as we reported here and here.

Many, however, are filed in California, where the state’s permissive consumer fraud laws erect a low bar.  One example is a very long-running hormone replacement therapy case called Krueger v. Wyeth, Inc., No. 3:03-cv-2496, 2019 WL 2743942 (S.D. Cal. July 1, 2019), where the district court certified a class of HRT patients several years ago, and recently denied the defendants’ motion for summary judgment in part, thus allowing a class of uninjured patients to claim hundreds of millions of dollars in so-called “restitution.”

Restitution of what?  Since the class members disavowed any personal injury and admitted that the drug provided benefits, what could they possibly be claiming?  Well, let’s dig a little deeper on that.  The case is styled as a consumer class action under California’s Unfair Competition Law (“UCL”) and Consumer Legal Remedies Act (“CLRA”), and it is brought on behalf of “all California consumers who purchased [the HRT products] for personal consumption between January 1995 and January 2003, and who do not seek personal injury damages.”  Id. at *1, *8.  These uninjured patients allege that the drug manufacturer did not adequately disclose certain risks prior to 2003 and, had they been fully informed, they would not have purchased the drug.  Id. at *7.

In allowing a restitution claim to go forward, the district court addressed three issues:  Standing, damages, and restitution.  On standing, the defendant justifiably argued that the plaintiff had not produced evidence of injury or reliance by class members on the alleged misrepresentations and omissions.  Id. at *5.  As a matter of substantive California law, the district court ruled that reliance can be presumed under the UCL and the CRLA “when the facts show that material misrepresentations were made to the entire class.”  Id.  We are aware of the cases that say that, and we don’t like them because they unacceptably weaken a fundamental requirement for proving fraud—that the alleged misrepresentation actually had an impact.  Regardless, because the plaintiff was claiming that the defendants “employed a standardized pervasive marketing campaign” that was misleading [id. at *1], the district court presumed reliance.  Id. at *5.

Article III standing was a more difficult question, but with the same result.  The district court adopted a two-step analysis:  “(1) ensuring that individual standing of the named plaintiff is supported by competent evidence and (2) examining the class definition to ensure that anyone within it would have standing.”  Id. at *6.  The first step was satisfied by the plaintiff’s contention that she would not have purchased the drugs “but for” the defendants’ alleged conduct; and the second step was satisfied by a presumption of reliance and causation in the case of a material fraudulent omission (recall that purportedly “standardized pervasive marketing campaign”).  Id. at *8.  The district court therefore ruled that the class of all uninjured purchasers had standing, but based only on a presumption.

On damages and restitution, the defendants argued that the plaintiff could prove neither because none of the models that her expert offered took into account the value that the class members received.  The named plaintiff herself testified that the product “alleviated hot flashes, reduced symptoms of insomnia, and improved memory and everyday functioning”; and her expert held the opinion that hormone therapy confers “significant benefits.”  Id. at *13.  In other words, the plaintiff got what she paid for, yet the plaintiff’s damages expert gave the defendant zero credit for that value conferred.

That gap was the death knell for actual damages under the CLRA:

Although Plaintiff argues that she would not have purchased HRT “but for” [the] deceptive conduct, when calculating actual damages, the Court must look to what actually occurred, taking into consideration that which Plaintiff did, in fact, receive and the market value of the product (both with and without the misrepresentation).

. . . .

Plaintiff offers no evidence of the monetary effect of the alleged misrepresentations or omissions on the market price of the Defendants’ products.

Id. at *11.  Because the district court was missing evidence necessary to calculate actual damages, it granted summary judgment as to those claims.  Id.

Although the analysis should have been the same or similar for restitution under the UCL, the district court denied summary judgment on that claim.  The court acknowledged that restitution is “broadly designed to ‘restore the status quo by returning to the plaintiff funds in which he or she has an ownership interest,” and it further acknowledged that restitution has two purpose:  “to restore the defrauded party to the position he would have had absent the fraud,” and “to deny the fraudulent party any benefits . . . which derive from his wrongful act.”  Id. at *12.

The court concluded, however, that it could measure restitution without accounting for the benefit that the drugs undisputedly conferred on the plaintiff and the class.  According to the court, the class members’ out-of-pocket expenses and the defendants’ profits (as calculated by the plaintiff’s expert) provided reasonable bases to calculate “restitutionary disgorgement.”  Id. at *12-*16.

The truck-sized hole through this conclusion is that these models of “restitutionary disgorgement” do not restore the status quo.  Instead, they place the plaintiff and class members in a better position because they get all their money back plus they keep the benefit they derived from taking a useful and helpful prescription drug without any adverse reaction.  That is not restitution.

So it goes.  Patients who received the beneficial prescription medication that they paid for and experienced no adverse impact whatsoever are in a position to claim hundreds of millions in “restitution.”  The law should not allow that.  Money for nothing.

We’ll get right to the point.  In Merck & Co. v. United States Department of HHS, ___ F. Supp.3d ___, 2019 WL 2931591 (D.D.C. July 8, 2019), the court held that the direct-to-consumer pricing regulation proposed by the Centers for Medicare & Medicaid Services (“CMS”) – on which we’ve commented here, and here – was an ultra vires exercise of nonexistent regulatory power.  Here are the key rulings:

As to the existence of statutory authorization – nope.  “The plain statutory text simply does not support the notion − at least not in a way that is textually self-evident − that Congress intended for the Secretary [of HHS] to possess the far-reaching power to regulate the marketing of prescription drugs.”  Id. at *7.  “[T]he delegation of authority that HHS says allows it ‘to speak with the force of law’ on the marketing of prescription drugs is nowhere to be found in the vast statute that is the SSA [Social Security Act].”  Id. at *8 (citation omitted).

As to general regulatory power being enough – nope, again.  “An agency’s general rulemaking authority plus statutory silence does not, however, equal congressional authorization.”  Id.  “[T]he SSA’s absence of an express limitation does not enable HHS to arrogate to itself the power to regulate drug marketing as a means of improving the efficiency of public health insurance programs.” Id.  “An agency cannot appropriate the power to regulate simply because Congress has not explicitly taken that power away.”  Id. at *9.

Because the court voided the regulation on administrative law grounds, it had no occasion to reach the First Amendment arguments that the drug company plaintiffs made (and we discussed in our prior ports).

Our initial post was entitled “The CMS DTC Drug Pricing Rule – FDA v. Brown & Williamson All Over Again?” – and indeed that was the case.  The first case involving an “other statute” that the Merck court cited was, indeed, FDA v. B&W:

In Brown & Williamson, the Supreme Court instructed that when “determining whether Congress has specifically addressed the question at issue, a reviewing court should not confine itself to examining a particular statutory provision in isolation.”  529 U.S. at 132.  Other statutes may bear on Congress’s intent.  “[T]he meaning of one statute may be affected by other Acts, particularly where Congress has spoken subsequently and more specifically to the topic at hand.”  Id. at 133.  That principle applies in this case.

Merck, 2019 WL 2931591, at *10.  If anybody has (and we don’t think so for the First Amendment reasons we discussed previously) the power to regulate prescription drug advertising in this way, it would be the FDA.  “Congress also has enacted specific legislation pertaining to television advertising of drug products” in “21 U.S.C. § 353c.”  Id.

Congress deliberately and precisely legislated in the area of drug marketing under the FDCA.  Such purposeful action demonstrates that Congress knows how to speak on that subject when it wants to.  It is therefore telling that the SSA contains no provisions concerning drug marketing.

Id. at *11.

Also quoting B&W, “[c]ourts ‘must be guided to a degree by common sense as to the manner in which Congress is likely to delegate a policy decision of such economic and political magnitude to an administrative agency.’”  Id.  CMS was fifty years late to the party:

Common sense dictates that Congress would not have authorized such a dramatic seizure of regulatory power based solely on general rulemaking authority under the SSA.  Further, it is not lost on the court that HHS has never before attempted to use the SSA to directly regulate the market for pharmaceuticals. . . .  [W]hen, as here, an agency claims to discover in a long-extant statute an unheralded power to regulate a significant portion of the American economy, courts should greet its announcement with a measure of skepticism.

Id. (citations and quotation marks omitted).

[T]he agency’s incursion into a brand-new regulatory environment, and the rationale for it, . . . make the Rule so consequential.  To accept the agency’s justification here would swing the doors wide open to any regulation, rule, or policy that might reasonably result in cost savings to the Medicare and Medicaid programs, unless expressly prohibited by Congress.  Indeed, the agency identifies no limiting principle, aside from an express statutory withholding of authority.

Id. at *12.  We always thought this was a lawless regulation, and now the first court to examine it has agreed.  We think CMS knows it, too, and is cynically pursuing a doomed strategy more to be perceived as “doing something” about drug prices, than actually expecting to accomplish anything.


You cannot get too much of a good thing, so let’s celebrate another good jurisdiction case out of Missouri. (Prior examples can be found here and here, among others.) In Timpone v. Ethicon, 2019 WL 2525780 (E.D. Mo. June 19, 2019), the plaintiff lawyers cobbled together 99 plaintiffs (a pure CAFA evasion) to file a complaint in Missouri state court alleging injuries from vaginal mesh. To be more specific, the complaint was filed in City of St. Louis Circuit Court, which can legitimately claim bragging rights for being the most pro-plaintiff court in our litigious land. The defendants were not citizens of Missouri. They were not “at home” in Missouri, under the Bauman SCOTUS case. Nor were 96 of the 99 plaintiffs at home in Missouri. Those 96 were citizens of other states. They were mere litigation tourists in Missouri. Perhaps they wanted a summer vacation in Branson. Perhaps their lawyers were opportunists who read more St. Louis verdict sheets than SCOTUS opinions – or at least read them more carefully.

The defendants removed the case to Missouri federal court. Then we are off to the races with competing jurisdictional motions. The plaintiffs moved to remand on the theory that some of those non-Missouri plaintiffs shared citizenship with the defendants, thereby depriving the federal court of diversity jurisdiction. The defendants moved to dump the non-Missouri plaintiffs for lack of personal jurisdiction over the defendants with respect to the non-Missourian claims.

It could matter a great deal which motion gets decided first. The plaintiffs were certainly hoping that the federal court would first decide lack of diversity jurisdiction, then remand the case to a state court that might not be so punctilious when it comes to the recent tightening of personal jurisdiction. By contrast, the defendants wanted the federal court to take a look at personal jurisdiction first, send the non-Missourians packing, then keep the case between the Missouri plaintiffs and the non-Missouri defendants.

Luckily for the defendants, after the Bristol-Myers Squibb SCOTUS case, judges in the Eastern District of Missouri have consistently held that the issue of personal jurisdiction is more straightforward than subject matter jurisdiction, so it goes first. And it really is straightforward in the Timpone case. The complaint contained no allegations that any of the non-Missourians’ injuries arose out of the defendants’ actions in Missouri. Sure, the defendants sold product in Missouri, but even such “regular and sustained” business does not create general personal jurisdiction over a defendant. Thus, the personal jurisdiction issue comes down to specific jurisdiction and, in the wake of Bristol-Myers Squibb, that is an obvious loser for the non-Missourians. It was certainly obvious to the Missouri federal judge. If the non-Missourians really were injured by the defendants, they weren’t injured by anything the defendants did in Missouri. The judge held that he lacked personal jurisdiction with respect to the claims by the 96 non-Missourians, and was required to dismiss the claims by those plaintiffs. The remaining three Missouri plaintiffs were diverse to the defendants, so the Timpone court had jurisdiction over those claims. That is a good result for the defendant and, as we said, it was perfectly obvious.

Why wasn’t this result obvious to the plaintiff lawyers? Do they not read? Or not care? Is it ignorance or defiance?

Today’s guest post is by Tucker EllisDick Dean, a longtime friend of the blog and outspoken advocate of using the Dormant Commerce Clause as a one-two punch in certain personal jurisdiction situations.  This is his latest update on Dormant Commerce Clause developments.  As always, our guest posters are 100% responsible for their writings, entitled to all the credit and any blame.


On June 26, the Supreme Court struck down a Tennessee statute that required two years of residency in order to open a liquor store because it violated the dormant commerce clause. Tennessee Wine and Spirits Retailer Assn. v. Russell Thomas, Executive Director of the Tennessee Alcoholic Beveridge Commission, Case No. 18-96, 2019 WL 2605555, ___S.Ct.___ (June 26, 2019).  There was no mention of pharmaceuticals or medical devices, but the decision is an important one for us.  Why?  The reasoning in the decision applies equally to consent statutes.  Bexis recently blogged whether such statutes pass due process muster but the statutes also don’t pass muster under the dormant commerce clause. You get saved from a long exposition of the dormant commerce clause and its application here because Steve McConnell and I have already done that in this blog.  Here, discussing Davis v. Farmers Cooperative Equity Co., 262 U.S. 312 (1923), striking down such a statute on commerce clause grounds.  Several other posts followed. Here and here.

But there is nothing like a Supreme Court decision applying the clause in a vigorous way to bring this point back to life.  The new decision is an ode to the clause.   “…the proposition that the Commerce Clause by its own force restricts state protectionism is deeply rooted in our case law.”  2019 WL 2605555, at *6.  The decision comes from a 7-Justice majority − written by Justice Alito with only Justices Gorsuch and Thomas dissenting.  [Ed. note:  An interesting split, as the DCC dissenters are “conservatives,” whereas the only personal jurisdiction dissenter (Sotomayor, J.) is a “liberal.”]

Davis has never been overruled.  Tennessee Wine did not discuss it but the ringing endorsement of the clause leaves little doubt but that Davis is still good law.

We should be making two constitutional arguments − not one − in attacking these statutes.

We’ve mentioned before that negligence per se requires a claimed violation of a definite enactment – like a 70 mile per hour speed limit – that can substitute for the ordinary negligence “reasonable man” standard.  However, we’ve never really studied it closely.  Because negligence per se seems to be flowing rather than ebbing in prescription medical product liability litigation these days, we thought we’d give that concept a closer look.

As stated in our prior post, from way back in 2007, vagueness is one of our “big five” negligence per se elements that state law (in most, if not all, jurisdictions) imposes:

Negligence per se must be consistent with the intent of whatever body enacted the provision allegedly violated.

Negligence per se is improper where it would impose novel duties that are not analogous to any existing common-law duty.

Negligence per se is improper in some jurisdictions where only a regulation, and not a statute, was violated. It is improper everywhere where the alleged transgression involved something that lacks full force of law.

Negligence per se is improper where the allegedly violated statute is vague or imprecise.

Negligence per se is improper where the allegedly violated statute only required that the defendant obtain a license of some sort.

The third item, a regulatory as opposed to a statutory enactment, affects the vagueness element, because ordinarily regulations are much more detailed – and thus less vague – than statutes.  Unfortunately, this third element is the least common among the states.  The most prominent jurisdiction adhering to this requirement is Ohio, where the highest court has determined, as matter of policy, that state tort law will not adopt negligence per se “duties” found solely in regulations.

If we were to rule that a violation of . . . an administrative rule[] was negligence per se, we would in effect bestow upon administrative agencies the ability to propose and adopt rules which alter the proof requirements between litigants.  Altering proof requirements is a public policy determination more properly determined by the [legislature]. . . .  Further, scores of administrative agencies propose and adopt perhaps hundreds of rules each year. Considering the sheer number and complexity of administrative rules, a finding that administrative rules establish negligence per se could open the floodgates to litigation. . . .  Only those relatively few statutes which this court or the [legislature] has determined, or may determine, should merit application of negligence per se should receive such status.

For all the aforementioned reasons, we hold that the violation of an administrative rule does not constitute negligence per se. . . .

Chambers v. St. Mary’s School, 697 N.E.2d 198, 202-03 (Ohio 1998) (citation and footnote omitted).  The Ohio Supreme Court has reaffirmed the Chambers limitation of negligence per se to statutory violations on multiple occasions.  E.g., Mann v. Northgate Investors, L.L.C., 5 N.E.3d 594, 601 (Ohio 2014) (if other negligence per se elements are met, “a violation of the statute constitutes negligence per se”); Lang v. Holly Hill Motel, Inc., 909 N.E.2d 120, 124 (Ohio 2009) (“administrative-rule violations do not create a per se finding of duty and breach of duty).

Another thing about the Ohio cases just cited – they require the enactment for which negligence per se is asserted to “set[] forth ‘a positive and definite standard of care . . . whereby a jury may determine whether there has been a violation thereof by finding a single issue of fact.’”  Lang, 909 N.E.2d at 124 (quoting Chambers, 697 N.E.2d at 201).  That’s the vagueness point.

Ohio is hardly alone in this requirement.  To save our and our readers; time, we’ll restate what we said about vagueness precluding negligence per se back in 2007:

Vagueness – Whether FDCA-related negligence per se lies for purported violations of administrative regulations – or even less – is particularly important because the most frequently invoked sections of the Act are rather broad and vague as to what constitutes, for example, adulteration or misbranding.  To the extent that these sections are given more precise substantive content, that precision is found in the Agency’s regulations.  Negligence per se is generally not permitted where the statutory standard that the defendant allegedly violated is vague or non-specific.

Implicit in virtually all discussions of negligence per se is the unspoken assumption that the regulation in question establishes a clear minimum standard of care.  If the regulation fails to do so, the reason for applying the doctrine fades. An ambiguous or contradictory regulatory standard defeats the certainty on which the rule of per se liability rests. Persons affected are deprived of a sure standard upon which they may fashion their affairs.

Dougherty v. Santa Fe Marine, Inc., 698 F.2d 232, 235 (5th Cir. 1983).  Dougherty applied Louisiana law.  Here are some more cases that refuse to allow vague, subjective standards created by statute or regulation to serve as negligence per se:


Thetford v. City of Clanton, 605 So. 2d 835, 842 (Ala. 1992) (no negligence per se where the statute “requires the [defendant] to file a report, but does not say where and does not say what should be done with the report”).


Shanks v. Upjohn Co., 835 P.2d 1189, 1201 (Alaska 1992) (no negligence per se “where a statute is too vague or arcane to be used as a reasonable standard of care, or amounts to little more than a duplication of the common law tort duty to act reasonably under the circumstances”); Dahle v. Atlantic Richfield Co., 725 P.2d 1069, 1073-1074 (Alaska 1986) (“This provision is not a proper basis for a negligence per se instruction because it amounts to little more than a duplication of the common law tort duty to act reasonably under the circumstances.”); Clabaugh v. Bottcher, 545 P.2d 172, 176 (Alaska 1976) (“where the jury must determine the negligence or lack of negligence of a party charged with the violation of a rule of conduct fixed by legislative enactment from a consideration and evaluation of multiple facts and circumstances by the process of applying, as the standard of care, the conduct of a reasonably prudent person, negligence per se is not involved”).


Reyes v. Frank’s Service & Trucking, LLC, 334 P.3d 1264, 1272 (Ariz. 2014) (“The statute ‘must proscribe certain or specific acts. . . .  Therefore, if a statute defines only a general standard of care . . . negligence per se is inappropriate’”) (quoting Hutto v. Francisco, 107 P.3d 934, 937 (Ariz. App. 2005)).


Ramirez v. Nelson, 188 P.3d 659, 666-67 (Cal. 2008) (no negligence per se where the enactment “did not give rise to any special standard of conduct or duty of care” but “merely assign[ed] strict criminal misdemeanor liability” to certain acts); Gravelin v. Satterfield, 132 Cal. Rptr.3d 913, 921 (Cal. App. 2011) (“Presumptive negligence under Evidence Code section 669 requires proof of a specific statutory or regulatory violation” and “Plaintiff failed to identify a specific regulation”); Fagerquist v. Western Sun Aviation, Inc., 236 Cal. Rptr. 633, 640 (Cal. App. 1987) (“the doctrine of negligence per se is not applicable unless the statute, rule or ordinance allegedly violated sets forth a specific standard of conduct.”).


Trinity Universal Insurance Co. v. Streza, 8 P.3d 613, 616 (Colo. App. 2000) (“To establish a claim for negligence per se, plaintiff must demonstrate: . . . (3) that the statute or ordinance proscribes or prescribes specific conduct”); Bauer v. Southwest Denver Mental Health Center, Inc., 701 P.2d 114, 118 (Colo. App. 1985) (“It is an essential element of negligence per se that the statute proscribe or prescribe specific conduct on the part of the tortfeasor, that is, detail whether particular acts shall or shall not be done by the party charged with observing the statute.”).


Pelletier v. Sordoni/Skanska Construction Co., 945 A.2d 388, 404 (Conn. 2008) (negligence per se argument “unpersuasive” where “the statutes in question . . . impose no specific duty); Pickering v. Aspen Dental Management, Inc., 919 A.2d 520, 525 (Conn. App. 2007) (“plaintiff’s negligence per se claim must fail” because the statute “does not set any particular standard of care”); Innis Arden Golf Club v. Pitney Bowes, Inc., 514 F. Supp.2d 328, 336 (D. Conn. 2007) (following “the requirement that negligence per se actions be based on a clear statutory standard of behavior aimed at individuals”).


Joseph v. Monroe, 419 A.2d 927, 931 (Del. 1980) (the enactment “which forms the basis of this action, also lacks the specificity required for the invocation of negligence per se”).

District of Columbia

Chadbourne v. Kappaz, 779 A.2d 293, 296-297 (D.C. 2001) (finding statute “too general . . . to be the subject of a negligence per se instruction”; collecting cases); Sibert-Dean v. Washington Metropolitan Area Transit Authority, 721 F.3d 699, 704 (D.C. Cir. 2013) (no negligence per se where “[i]t is not possible to tell whether a person has violated the standard set by this regulation without evaluating his or her actions against a common sense (and common law) baseline of reasonable behavior”); Joy v. Bell Helicopter Textron, Inc., 999 F.2d 549, 558 (D.C. Cir. 1993) (“an alleged violation of a statute or regulation gives rise to a claim of negligence per se only when that statute or regulation sets forth specific guidelines to govern behavior”) (applying District of Columbia law).


Murray v. Briggs, 569 So.2d 476, 481 (Fla. App. 1990) (“At the very least, any regulation that purports to establish a duty of reasonable care must be specific.  One that sets out only a general or abstract standard of care cannot establish negligence.  Here the regulation is vague and general.”); Liese v. Indian River County Hospital Dist., 701 F.3d 334, 353 (11th Cir. 2012) (plaintiff did not “establish a sufficiently specific duty to allow relief under an evidence of negligence theory”; “a general duty to provide effective communication is insufficient under Florida law to state a negligence claim predicated upon the violation of a statute or regulation”) (applying Florida law).


Allen v. Lefkoff, 453 S.E.2d 719, 722 (Ga. 1995) (‘the failure to comply with general rules of conduct will not ordinarily constitute negligence per se”) (citation and quotation marks omitted); King v. Avtech Aviation, Inc., 655 F.2d 77, 79 (5th Cir. 1981) (regulation that “does not require specific conduct and is far too broad to establish a standard of care” cannot support negligence per se) (applying Georgia law).


Stem v. Prouty, 272 P.3d 562, 568 (Idaho 2012) (“The doctrine of negligence per se mandates that the statute or ordinance must clearly define the required standard of conduct.”); Stott v. Finney, , 950 P.2d 709, 711 (Idaho 1997) (“The principles relating to the doctrine of negligence per se . . ., predicated upon the violation of a statute or regulation, are well settled.  First, the statute or regulation must clearly define the required standard of conduct.”).


Kovera v. Envirite, Inc., 26 N.E.3d 936, 955-56 (Ill. 2015) (where “the statute and the jury instructions representing the common law both stated exactly the same thing − that [defendant] would be negligent if he was not [acting] reasonably under the circumstances” there was no need to instruct on negligence per se); Stogsdill v. Manor Convalescent Home, Inc., 343 N.E.2d 589 (Ill. App. 1976) (no negligence per se because the regulations were “too vague to be sufficient indicators of the standard of due care”); Heisner v. Genzyme Corp., 2008 WL 2940811, at *7 (N.D. Ill. July 25, 2008) (a “negligence per se claim [that] . . . merely reiterates . . . general reporting requirements . . . will simply duplicate the claims of . . . overall negligence, and will likely be stricken”).


Lindsey v. DeGroot, 898 N.E.2d 1251, 1260 (Ind. App. 2009) (negligence per se “is founded in the defendant’s violation of a specific requirement of law”); Board of Commissioners v. Briggs, 337 N.E.2d 852, 865 (Ind. App. 1975) (negligence per se “is a violation of a specific requirement of law or ordinance”).


Winger v. CM Holdings, L.L.C., 881 N.W.2d 433, 4445 (Iowa 2016) (“the breach of a specific safety-related requirement . . . with the force of law may constitute negligence per se”); Struve v. Payvandi, 740 N.W.2d 436, 442-443 (Iowa App. 2007) (“in order to establish a violation the statute must have enough specificity to establish a standard of conduct”; “This statute does not contain a specific standard of conduct from which a fact finder could find a violation”).


Kerns v. G.A.C., Inc., 875 P.2d 949, 961 (Kan. 1994) (negligence per se “results from violation of the specific requirement of law or ordinance; and the only fact for the determination of the factfinder is the commission or omission of the specific act inhibited or required”) (quoting Watkins v. Hartsock, 783 P.2d 1293, 1297 (Kan. 1989)).


We didn’t find anything particular in Kentucky, but we remind our readers that Kentucky law doesn’t allow negligence per se based on the violation of any federal (as opposed to state) enactment – a quirk that we discussed here.


Meany v. Meany, 639 So. 2d 229, 235 (La. 1994) (“The violation of a legislative enactment commanding or prohibiting a specific act to ensure the safety of others arguably constitutes negligence per se.”); Dougherty, supra.


Pacific Indemnity Co. v. Thompson-Yaeger, Inc., 260 N.W.2d 548, 559 (Minn. 1977) (in negligence per se the “statute or ordinance imposes a fixed duty of care, so its breach constitutes conclusive evidence of negligence”); In re Shigellosis Litigation, 647 N.W.2d 1, 10 (Minn. App. 2002) (negligence per se only proper “[i]f a statute defines the fixed standard of care”).


Westbrook v. City of Jackson, 665 So. 2d 833, 837 (Miss. 1995) (“Negligence per se is not applicable here” because the enactment “does not require the specific placement of [items] in a certain point”); Estate of Hazelton v. Cain, 950 So. 2d 231, 235 (Miss. App. 2007) (where “[n]o language is included [in the act] which creates a specific legal duty,” negligence per se will not lie).


Parr v. Breeden, 489 S.W.3d 774, 781 (Mo. 2016) (“the essential elements of a negligence per se claim[] includ[e] that defendants violated a specific statute or regulation”); Glover v. Atchison, Topeka, & Santa Fe Railway Co., 841 S.W.2d 211, 214 (Mo. App. 1992) (no negligence per se because “the rule was not of a specific nature”); In re Genetically Modified Rice Litigation, 666 F. Supp.2d 1004, 1022 (E.D. Mo. 2009) (negligence per se claim dismissed where regulations “are not sufficiently precise about what a person must do to comply. . . .  They do not dictate the method of reaching that result, and so they do not provide a standard of care.”).


Jeffres v. Countryside Homes, Inc., 333 N.W.2d 754, 760 (Neb. 1983) (negligence per se is allowed when “there has been substituted for the general standard of reasonableness a specific rule of conduct”).

New Hampshire

Yost v. US Airways, Inc., 2011 WL 1655714, at *4 (D.N.H. May 2, 2011) (“The problem with plaintiffs’ invocation of the negligence per se doctrine is that the regulation on which they rely simply does not establish a standard of conduct”).

New Mexico

Heath v. La Mariana Apartments, 180 P.3d 664, 666 (N.M. 2008) (“when a statute imposes a specific requirement, there is an absolute duty to comply. . . .  However, where duties are undefined, or defined only in abstract or general terms, leaving it to the jury to evaluate the factual circumstances of the particular case to determine whether the defendant acted reasonably, then a negligence per se instruction is not warranted”) (citations omitted); Parra v. Atchison, Topeka & Santa Fe Railway Co., 787 F.2d 507, 509 (10th Cir. 1986) (“The critical inquiry in such [negligence per se] cases is whether the rule itself is of a specific nature allowing plaintiff’s actions to be evaluated objectively.”) (applying New Mexico law).

New York

Yenem Corp. v. 281 Broadway Holdings, 964 N.E.2d 391, 394 (N.Y. 2012) (“violation of a State statute that imposes a specific duty constitutes negligence per se”); Morris v. Pavarini Construction, 874 N.E.2d 723, 726 (N.Y. 2007) (negligence per se applicable “only where the regulation in question contains a specific, positive command” and “not where the regulation itself, using terms like ‘adequate,’ ‘effective,’ ‘proper,’ ‘safe,’ or ‘suitable’”); Nicholson v. South Oaks Hospital, 811 N.Y.S.2d 770, 771 (N.Y.A.D. 2006) (negligence per se dismissed where the enactments “do not impose a specific duty on the defendants”); Sheila C. v. Povich, 781 N.Y.S.2d 342, 352 (N.Y.A.D. 2004) (“[b]ecause the statute sets forth a general, abstract standard prohibiting individuals from knowingly engaging in [certain] acts . . ., without specifically defining those acts, it cannot support a claim for negligence per se”).

North Carolina

Stein v. Asheville City Board of Education, 626 S.E.2d 263, 266 (N.C. 2006) (negligence per se requires a statute “imposing upon the defendant a specific duty for the protection of others”); Goodman v. Wenco Foods, Inc., 423 S.E.2d 444, 452 (N.C. 1992) (no negligence per se where the enactment “provides no standard by which to comply with that duty” that it imposed); Jones v. GMRI, Inc., 551 S.E.2d 867, 873 (N.C. App. 2001) (“although the Act imposes . . . a general duty . . ., it does not provide a ‘standard by which to comply with the duty” and cannot be negligence per se) (following Goodman).


Lang, supra; Chambers, supra; Rimer v. Rockwell International Corp., 641 F.2d 450, 455 n.2 (6th Cir. 1981) (“A finding of negligence per se requires a violation of a statute which sets out a specific standard of conduct”).


Athey v. Bingham, 823 P.2d 347, 349 (Okla. 1991) (negligence per se improper where “the terms of the statute . . . do not impose any positive objective standards nor do they proscribe any greater or lesser degree of care than that required of a driver under the prevailing rules at common law.”) (citation and quotation marks omitted)


Kim v. Multnomah County, 153, 970 P.2d 631, 638 (Or.1998) (“Neither is the statutory duty . . . to make investigations and reports as a judge may from time-to-time require sufficiently specific to so fix the legal standard.”); Shahtout v. Emco Garbage Co., 695 P.2d 897, 899 (Or. 1985) (negligence per se only applies where an enactment “so fixes the legal standard of conduct that there is no question of due care left for a factfinder to determine”).


Shamnoski v. PG Energy, Division of Southern Union Co., 858 A.2d 589, 601 (Pa. 2004) (“a per se negligence holding is warranted” where “the statute at issue [is] so specific as to leave little question that a person or entity found in violation of it deviated from a reasonable standard of care”); Young v. Commonwealth DOT, 44 A.2d 1276, 1279 (Pa. 2000) (no negligence per se because “the code does not provide more guidance” how to carry out claimed duty); In re TMI, 67 F.3d 1103, 1115 (3d Cir. 1995) (a “vague and elusive standard” cannot support negligence per se) (applying Pennsylvania law); Ries v. National Railroad Passenger Corp., 960 F.2d 1156, 1163 (3d Cir. 1992) (“we question whether general workplace regulations can create a statutory duty of care”) (applying Pennsylvania law); Beaver Valley Power Co. v. National Engineering & Contracting Co., 883 F.2d 1210, 1222 (3d Cir. 1989) (“general exhortations to maintain the facility in a ‘safe’ condition and to take ‘necessary’ action . . . do not provide guidance as to a legislative judgment that the failure to engage in certain conduct constitutes negligence”) (applying Pennsylvania law).

South Dakota

Albers v. Ottenbacher, 116 N.W.2d 529, 532 (S.D. 1962); (“the violation by the [defendant] of a statute or ordinance containing specific requirements . . . is negligence per se”); Schiernbeck v. Davis, 143 F.3d 434, 440 (8th Cir. 1998) (“A violation of a statute which sets forth specific duties constitutes negligence per se.”) (applying South Dakota law).


Conley v. Life Care Centers of America, Inc., 236 S.W.3d 713, 733 (Tenn. App. 2007) (negligence per se claim dismissed because “[t]he federal regulations are simply too vague and general to constitute a standard of care by which a jury, or for that matter a court, can effectively judge the [defendant’s] acts or omissions”); Rains v. Bend of the River, 124 S.W.3d 580, 591 (Tenn. App. 2003) (no negligence per se where the enactment “does not contain a clearly defined standard of conduct”); King v. Danek Medical, Inc., 37 S.W.3d 429, 458 (Tenn. App. 2000) (only a violation of an “ordinance [with] precise and readily understandable requirements” can be negligence per se).


Perry v. S.N., 973 S.W.2d 301, 307-08 (Tex. 1998) (“[O]ne consideration bearing on whether to apply negligence per se is whether the statute clearly defines the prohibited or required conduct.”’ “A statute that conditions the requirement to report on these difficult judgment calls does not clearly define what conduct is required in many conceivable situations.”); Carter v. William Sommerville & Son, Inc., 584 S.W.2d 274, 278 (Tex. 1979) (negligence per se proper where “the statute clearly defines the prohibited conduct”); Omega Contracting, Inc. v. Torres, 191 S.W.3d 828, 840-841 (Tex. App. 2006) (“the word ‘loose’ is vague and not susceptible of precise meaning” and “is not an appropriate standard for applying negligence per se”).


Green v. Denver & Rio Grande Western Railroad Co., 59 F.3d 1029, 1034 (10th Cir. 1995) (negligence per se limited to “specific, objective safety rules”).


Talley v. Danek Medical, Inc., 179 F.3d 154, 161 (4th Cir. 1999) (negligence per se permissible as to “a specific and substantive standard of care” imposed by statute) (applying Virginia law); Ridge v. Cessna Aircraft Co., 117 F.3d 126, 131 (4th Cir. 1997) (“the regulations at issue were too general to form the basis of an instruction that this violation would constitute negligence as a matter of law”) (applying Virginia law).


Taft v. Derricks, 613 N.W.2d 190, 194 (Wis. App. 2000) (“Negligence per se arises when the legislature defines a person’s standard of care in specific instances.” “When a statute provides that under certain circumstances particular acts shall or shall not be done, it may be interpreted as fixing a standard”).


Short v. Spring Creek Ranch, Inc., 731 P.2d 1195, 1199 (Wyo. 1987) (“to invoke the statute or regulation as a standard the statute or regulation must prescribe or proscribe specific conduct.  Using the statute or regulation as a standard is not appropriate if it sets out only a general or abstract standard of care.”).

Note:  Arkansas, Maryland, Michigan, New Jersey, and Washington do not recognize negligence per se at all, which we think accounts for lack of precedent on the specificity element.

Indulge us for a moment as we recount another airline adventure. Recently, we traveled thousands of miles to an important argument. Our first flight boarded right on time, left the gate right on time, and taxied down the runway . . . partway. Then stopped. Enter the inevitable announcement: “Ladies and gentlemen, we’re very sorry, but . . . .” This time, there was “cargo” that had been loaded onto the plane by mistake. Lest the perpetrator of the mistake suffer the consequences, the airline jeopardized the connections of a planeload of business travelers.  Finally, we left the gate again. And taxied again. And stopped again. “Ladies and gentlemen . . . .” This time, the captain pointed out the crew cleaning up a deceased bird on our runway.   We finally took off, more than an hour late.  The crew radioed ahead to the connecting city. And we held our breath. We ran up the jetway in the connecting airport with only a few minutes until our connecting flight was scheduled to depart. The plane was a few gates over and was still there.   But . . . “We’re very sorry, ma’am, but boarding is closed.” And we watched the plane fly away without us. Needless to say, we were not terribly polite about this. We ended up renting a car and driving, luckily only a few hours, to our destination. It was our only chance, and we took it. (We also scored 7.500 bonus miles with a very annoyed call to the airline’s customer service department.)

In today’s very short decision, Collette v. Wyeth Pharms., Inc, 2019 WL 2603280 (N.D. Cal. June 25, 2019), the plaintiff was similarly afforded a chance to save his claims but mostly failed to seize the opportunity.  The plaintiff alleged that the defendant’s generic heart medication had caused him to develop pulmonary fibrosis.   He sued the manufacturer of the branded version of the drug along with the subsidiary that manufactured the generic version, asserting the usual product liability claims.  The court had granted the defendants’ original motion to dismiss the complaint but had granted the plaintiff leave to amend several of the claims.

Not so the warnings-related claims, which were dismissed with prejudice on the original motion because, as the court correctly held, they were preempted under Mensing and Bartlett. In his amended complaint, the plaintiff stated that he did not “allege that the warning label or package insert [was] inadequate or should be changed” and that he “[made] no allegations regarding the adequacy of the label.”   Collette, 2019 WL 2603280 at *1. The court disagreed, citing language in the complaint that contained “echoes of the warning and labeling claim” that had been dismissed with prejudice. The court held that these claims had “already been dismissed and [were] not properly before the Court.” Id.

Failure to Provide Medication Guides

In his original complaint, the plaintiff claimed that the defendants failed to distribute a “medication guide” with the drug.   On the original motion to dismiss, the court held that the plaintiff had not included enough detail to state a plausible cause of action; for example, he had not even identified the pharmacy where he filled his prescriptions.   The court also noted that the claim was likely preempted by Buckman to the extent that it was based only on duties arising from federal regulations.

In his amended complaint, the plaintiff failed to supply any additional factual support for the claim – not even the name of the pharmacy where he filled his prescription. The court held that the claim “continue[d] to fail” Twiqbal’s “plausibility requirements.”  In addition, the court held that the claim did “indeed” appear to be based only on federal regulatory duties – that the plaintiff had failed to identify a parallel state duty that would have required the defendants to distribute a medication guide.   As such, preemption provided an “alternative and independent basis for dismissal.” Id. at *2.   This time, the court dismissed the claim with prejudice.

Off-Label Marketing

On the original motion, the court had held that the plaintiff’s off-label marketing claim sounded in fraud and failed to meet the heightened particularity standard of Rule 9(b). The court instructed the plaintiff to “say much more about what, specifically, each defendant said and did, and how these statements and actions (or lack thereof)” related to the plaintiff and to his doctor. Id. The amended complaint again failed to provide this detail, mentioning FDA enforcement actions against one of the defendants but not tying “any of this in any concrete way” to the plaintiff or to his doctors. The court held that the claim read “much more like a general investigative report than an actionable complaint” for a specific injury attributable to the defendants. Id. Inexplicably, however, the court again dismissed this claim without prejudice and gave the plaintiff one final opportunity to amend this claim.

So the plaintiff has one last chance to save his sole remaining claim.   We’ll be watching to see if he does. And we’ll keep you posted.