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). SeeKisor, 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 enforcementletters 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 Ellis‘ Dick 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 mentionedbefore 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”).
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”).
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).
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”).
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).
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..
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.
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.
We like preemption and we dislike expensive discovery. In Gale v. Mentor Worldwide, LLC, 2019 WL 2567790 (D. Kansas June 21, 2019), the court felt the same way we do, and did something about it.
The plaintiff in Gale sued for injuries allegedly sustained as a result of silicone breast implants. The complaint contained the usual claims for failure to warn, manufacturing defect, and design defect. Breast implants went through the rigorous Pre-Market Approval process, which permitted the defendant to move to dismiss on grounds of preemption via the Medical Device Amendments. The defendant also moved to stay discovery pending resolution of the motion to dismiss.
Kansas is in the Tenth Circuit, and the Gale court tells us that the Tenth Circuit does not favor stays of discovery. The Tenth Circuit is probably not very different from other courts in that respect. Judges everywhere at least pay lip service to the notion that things should move along. Thus, a party seeking a stay of discovery must “clearly show a compelling reason” for the stay. That sounds like a tough standard. The Gale court goes on to say that the pendency of a dispositive motion is not necessarily, er, dispositive in terms of supporting a stay of discovery. All that judicial throat-clearing aside, if it truly looks like the motion is likely to end the case, a stay of discovery makes sense, especially where the facts sought through the remaining discovery would not affect the ruling on the pending motion.
Perhaps that sounds a little squishy for your taste. Discovery is a one-way ratchet that plaintiffs use to bang corporate defendants on the noggin. It ends up costing much more money than most civil defendants who are found liable end up paying. Discovery also disrupts business operations. Those corporate witnesses who are forced to sit in conference rooms while plaintiff lawyers drone on endlessly with questions ending, “did I read that correctly?” actually have jobs to do. And what about the Sixth Amendment? But bank on this: the first thing that plaintiffs will say when you tell them you’re going to file a preemption motion is that they will need discovery to test the preemption theory.
Consequently, it is perfectly understandable that the defendant in the Gale case tried to find a more robust theory supporting a stay. What it came up with is the notion that a stay is appropriate “when the party requesting it has filed a dispositive motion asserting absolute immunity.” Okay, we get why the defendant dresses preemption in the garb of immunity. We have more than once praised the power of preemption in that it halts a case even if so many other aspects of the claim are in the plaintiff’s favor. The defendant even found a Tenth Circuit case that used the word “immunity” to describe the protection from state tort suits that preemption brings. But the Gale court held that the use of the word “immunity” was merely “coincidental” or rhetorical, and refused to extend the immunity analysis to the defendant’s request to stay discovery pending resolution of the preemption motion.
Still, in Gale, the defendant had a very good PMA preemption defense – that is to say, it had a PMA preemption defense. Perhaps preemption is not technically “immunity,” but the same considerations warrant a stay of discovery pending decision on the preemption issue. It helped that the defendant cited six cases – four federal and two state – that stayed discovery pending similar motions to dismiss by the same defendant. Maybe those cases weren’t controlling, but they gave the Gale court reason for pause – and reason to pause discovery in that case, because a grant of the motion to dismiss seemed likely enough. PMA preemption is, or at least should be, fairly straightforward, and no discovery dreamt up by plaintiff lawyers can affect the analysis. Therefore, even absent a specific showing by the defendant that the discovery in the Gale case was especially burdensome, any discovery would turn out to mean “the parties would have incurred unnecessary expense.” The Gale court exercised its discretion to stay discovery.
What is the ultimate takeaway from Gale? Forget about the rejection of the immunity argument. That was a clever argument that was hardly devoid of merit, but it is no shocker that the court didn’t plump for it. The court was probably worried about how far that theory might go. No, the meaning of Gale is that the pendency of a PMA preemption motion by itself establishes a clearly compelling reason to stay discovery. It might be a good idea to lay out for the court why discovery would be gruesomely oppressive and costly, but Gale says you do not need to do that.
Did you ever wish there was a way to get a definitive answer to those age-old issues that have been plaguing humans since the beginning of time? Like — is it worse to fail at something or never attempt it in the first place? Or — does nature shape our personalities more than nurture? What about the questions the only plague us when we are stuck in traffic or at three in the morning. Why is it said that an alarm clock is going off when really it’s coming on? At a movie theater which arm rest is yours? When does it stop being partly cloudy and start being partly sunny? Why are there no “B” batteries?
Alas, even in the age of asking Siri, certain answers remain elusive. But, long before Alexa was searching Google, courts had a system in place for getting to the bottom of an issue – the certified question. A neat little device whereby one court asks another court, usually of higher authority, for an opinion on a question of law. That’s just what the Eastern District of Pennsylvania did in Rosenberg v. C.R. Bard, Inc., __ F. Supp. 3d __, 2019 WL 2596358 (E.D. Pa. Jun. 25, 2019). Faced with competing decisions on an issue of Pennsylvania law, the district court rendered its decision, but is certifying a question to the Third Circuit for an immediate interlocutory appeal. The question is:
[D]oes Pennsylvania law recognize a strict liability claim for a manufacturing defect of a prescription medical device?
Id. at *7. It may not be a question as old as why doesn’t glue stick to the inside of the bottle? But, it has been open to debate for several years.
Pennsylvania has long applied comment k of §402A of the Restatement (Second) of Torts across the board to bar strict liability design and warning claims. Comment k exempts “unavoidably unsafe products” from strict liability when they are properly prepared and accompanied by proper warnings. If §402A “defines the general scope of strict liability,” comment k “sets the perimeter beyond which Section 402A many not encroach.” Rosenberg, at *3.
Rosenberg walks through Pennsylvania’s history with comment k. The Pennsylvania Supreme Court has held that comment k applies to prescription drugs. Hahn v. Richter, 673 A.2d 888 (Pa. 1996). But Rosenberg involves a prescription medical device and the applicability of comment k to medical devices has not been answered by Pennsylvania’s highest court. Both Pennsylvania Superior Courts and federal courts applying Pennsylvania law, however, have held that Pennsylvania would extend comment k to prescription medical devices as well. Rosenberg does too. Rosenberg at *3-4. But that’s the easy part of the issue.
Going back to Hahn, Pennsylvania has said the comment k bars strict liability claims for design defect and failure to warn. Id. at *5. But the plaintiff in Rosenberg also alleged a strict liability manufacturing defect claim. Whether that claim is permissible is less certain and federal courts interpreting Pennsylvania law have come out differently. That’s because the trend in Pennsylvania courts has gone back and forth with no definitive answer.
First, there was Lance v. Wyeth, 4 A.3d 160, 164-65 (Pa. Super. Ct. 2010) (Lance I), in which the Pennsylvania Superior Court in dismissing a claim for negligent marketing said that a strict liability manufacturing defect claim was possible in a prescription drug case. But, the Pennsylvania Supreme Court reversed Lance I finding the court’s reasoning “deeply flawed” and that it erroneously equated “products liability” with “strict liability.” Lance v. Wyeth, 85 A.3d 434, 453 (Pa. 2014) (Lance II). So, many courts, including Rosenberg, find that Lance I “is entitled to no weight.” Rosenberg at *6.
Lance II also held that the Pennsylvania Supreme Court “ha[d] declined to extend strict liability into the prescription drug arena” but had not immunized drug manufacturers from other types of liability. Id. Which courts have come to interpret as Pennsylvania recognizes negligence claims for prescription drugs, but not strict liability claims. Id.
Then came Tincher v. Omega Flex, Inc., 104 A.3d 328, 382 (Pa. 2014) in which the Pennsylvania Supreme Court said that “[n]o product is expressly exempt” from strict liability. Which plaintiffs tried to use, mostly unsuccessfully, to open the door to strict liability in drug and device cases in Pennsylvania. But Tincher is actually quite clear because that quoted language is followed by: “but see Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (Pa. 1996) (manufacturer immune from strict liability defective design claim premised upon sale of prescription drugs without adequate warnings.” Tincher, 104 A.2d at 382 (emphasis added). “Therefore, nothing in Tincher reopens the door to strict liability claims for prescription drug or prescription medical devices, a door Hahn had firmly closed.” Rosenberg, at *6.
Based on its analysis, the Rosenberg court dismissed plaintiffs’ strict liability claims, including for manufacturing defect, with prejudice. Id. at *8. However, it also concluded that the issue met the requirements for certification for interlocutory appeal. The issue is a controlling question of law on which there is “substantial ground for difference of opinion,” and deciding the issue now will conserve resources and avoid protracted litigation. Id. at *7. There is a chance the Third Circuit will in turn certify the question to the Pennsylvania Supreme Court (federal district courts can’t do this) and we’ll finally have an answer as to comment k and both medical devices and manufacturing defects in Pennsylvania. Now, if only someone could answer whether the “s” or the “c” is silent in scent?
We’ve repeatedly advocated that defendants try turn the e-discovery tables on plaintiffs whenever possible – particularly in MDLs where discovery is flagrantly one-sided – by going after plaintiffs’ social media information. In just about every case involving allegations of personal injuries, social media will have admissions by plaintiffs concerning their conditions and activities that concern and often contradict their claims. Heck, we even have a cheat sheet with over 100 favorable cases requiring personal injury plaintiffs to produce material posted on Facebook, MySpace (that used to be a thing), Twitter, Snapchat, and even fitness watch data.
We got our hands on a recent public filing in the Taxotere MDL that details how such a strategy can force MDL plaintiffs to be on the receiving end of, if not a fair share, then at least a decent share of ediscovery. Taxotere has always struck us as a good candidate for a plaintiff-focused ediscovery strategy because the drug is used in chemotherapy cancer treatments and – as if this wasn’t a notorious side effect – causes hair loss. E.g., In re Taxotere (Docetaxel) Products Liability Litigation, 220 F. Supp.3d 1360, 1361 (J.P.M.L. 2016). Since Taxotere focuses on appearance, and so does much of social media, ediscovery against plaintiffs’ electronically stored information (“ESI”) would be both highly relevant, and extremely proportionate.
Plaintiffs dish out ediscovery in every MDL. Can they take it?
Apparently not – at least not very well.
According to the defendant’s filing, spoliation (either by failing to preserve or actively deleting) relevant social media ESI approached the scale of a plaintiff-side modus operandi in Taxotere. From the beginning of the Taxotere MDL, defendants sought discovery of plaintiff-side ESI. These efforts started with an early case management order (PTO 49) approving plaintiff fact sheets that also specifically incorporated production of such ESI. PTO 49 was accompanied by a 20-page “ESI Protocol,” applicable to all parties in all cases. Critically, nothing in either PTO 49 or the accompanying protocol was limited to the defense ESI production (although, realistically, some provisions were highly unlikely to apply to individuals).
That’s the first step defendants must take. From the beginning, discovery must be a two-way street, and the plaintiffs’ MDL discovery obligations must explicitly include ESI. Plaintiffs, as well as defendants, should have to comply with ESI-related litigation holds. In Taxotere, that order went into effect in July, 2017.
By the way, if you want to follow along with the Taxotere saga at home, the Taxotere MDL may be found here on PACER.
Most Taxotere plaintiffs did what MDL plaintiffs normally do, which is nothing, or as close to nothing as they can get away with. In so doing, however, they violated the in-place court order, usually by filing fact sheets that did not even purport to include ESI. According to defendants, by October, “[o]f the 1,179 Plaintiffs who had submitted a PFS . . ., only 21 had produced ESI.”
Taxotere defendants did not allow this plaintiff-side passive-aggressive approach to MDL discovery to continue any longer. Motion practice produced another case management order (Pre-Trial Order (“PTO”) 71A), in January, 2018, specifically addressing the MDL plaintiffs’ ESI discovery failings:
Concerned that certain Plaintiffs in this MDL do not appear to have adequately and timely produced responsive electronically stored information (“ESI”) as required by the Plaintiff Fact Sheet (“PFS”), the Court enters this Order governing Plaintiffs’ identification, preservation, collection, and production of ESI. The Court also orders all Plaintiffs and their counsel to review and familiarize themselves with the revised “Guidance Regarding Potential Sources of Electronically Stored Information,” attached here as Exhibit A.
Id. at p.1 (emphasis added). We’re also attaching the ESI “guidance” that was an exhibit to PTO 71A. There’s no reason to reinvent the wheel in each MDL.
Taxotere PTO 71A put plaintiffs squarely behind the 8-ball on ESI discovery. It applied to “all plaintiffs” and “all document requests.” Id. ¶ 1. It covered “any” social media from “five (5) years prior to [a plaintiff’s] docetaxel treatment” onwards. It provides a good definition of plaintiff-side social media that must be produced:
(i) any email accounts used by plaintiff; (ii) any electronic devices used by plaintiff (e.g., desktop or laptop computers, tablets, mobile phones, digital cameras); (iii) any other hardware storage devices used by plaintiff (e.g., external hard drives, memory cards, USB or thumb drives, CDs/DVDs); (iv) any social media used by plaintiff (e.g., Facebook, Instagram, LinkedIn, Twitter, MySpace, YouTube, Pinterest, or other online collaboration tools such as Google+ or Yahoo! groups); (v) any website where a plaintiff made online postings (e.g., on a blog, message board, etc.); (vi) any cloud storage used by plaintiff (e.g., DropBox, Microsoft Office365 Account, Google Drive, iCloud, Amazon Drive, etc.).
Id. ¶2. Again, don’t reinvent the wheel – but social media is constantly evolving, so do keep up to date on new forms of social media that might need to be added. The order even defined what a “reasonably diligent” ESI search entailed, so plaintiffs couldn’t continue avoiding discovery by playing dumb:
Reasonably diligent searches may require running search terms; reviewing files, communications, videos, and photographs; or otherwise conducting an actual, physical search of the sources. Plaintiff’s counsel shall take an active role in identifying, preserving, collecting, reviewing, and producing all responsive ESI.
PTO 71A included 15 specific search terms that plaintiffs had to use. Id. ¶4. Plaintiffs were required to “produce all responsive ESI in a manner that preserves any metadata.” Id. ¶5. In addition to producing the ESI itself, the court required a “written statement” signed by both plaintiff and counsel and subject to Fed. R. Civ. P. 26(g)(3) (concerning discovery sanctions), providing:
a. A description of any employer-owned email accounts, other individuals or other locations, and resources where responsive ESI may exist; and
b. A description of unique, non-duplicative ESI within the scope of discovery that was lost or destroyed and whether plaintiff used any consumer backup tools (e.g., Carbonite, Backblaze, Crashplan, etc.).
The “guidance” accompanying the Taxotere PTO 71A included a series of instructions to plaintiffs’ counsel on how to obtain their clients’ compliance with ESI discovery. It discussed:
That “reasonable inquiry” is required to avoid sanctions.
Where to look and what to look for – especially photographs, emails, text messages, and social media posts.
Providing clients with a source of technical expertise (a “tech nerd”) to facilitate the inquiry.
Overcoming “pushback” from recalcitrant clients.
What clients did when they replaced or upgraded their hardware, and what they will do in the future.
That clients must search old hardware and abandoned social media accounts.
Preservation of metadata.
Time limits and relevancy limits to searches.
In short, ediscovery against plaintiffs in Taxotere was no joke. Plaintiffs – and their counsel − were actually expected to do work in responding to discovery.
Still the Taxotere plaintiffs resisted, disobeyed, and withheld information. Their failure to comply with discovery was particularly blatant concerning an on-line support group (“Taxotears”) that many of them belonged to. Such product-specific online groups are common, and thus relevant in many MDLs. Plaintiffs refused even to identify the members of this group. The defendants didn’t give up, and their pursuit of plaintiffs’ discovery evasions led to entry of another discovery order in May, 2018.
The PSC will identify every Plaintiff in this Multidistrict Litigation who was or is a member of the Taxotears group. That information will be provided to [defendant] no later than [a date certain]. . . . [T]he names of non-Plaintiff members on that list may be redacted by the PSC.
Counsel for each Plaintiff who is identified as a current or past member of the group is to be notified by the PSC of the fact that their client’s name is on that list and the PSC is to provide counsel with a copy of this Discovery Order.
May, 2018 Order at 1. Then counsel were required to to back and check those names against plaintiff fact sheets “to identify Plaintiffs whose Plaintiff Fact Sheets may be deficient with respect to information regarding their membership in the Taxotears group.” Id. at p.2. The court also entered a “preservation order” against plaintiffs:
All Plaintiffs are hereby specifically ordered by the Court to retain and preserve any and all materials to which they have access through the [support] group and to refrain from any efforts to dispose of or delete any emails, posts or other electronic information sent or received by them or accessible to them by virtue of their membership in that group.
Furthermore, any Plaintiff who is a current member of the [support] group is hereby prohibited from ending her membership in that group until further order of the Court. This order is intended solely to preserve the status quo and the ability of every Plaintiff member and/or her counsel to continue to have access, to whatever extent access is possible, to information available to members of the [support] group.
Id. pp.2-3. Defendants also were granted the right to take depositions to understand how the support group operated and what discoverable material it had. Id. at p.3. Not a single one of those plaintiffs thereby identified had produced the required ESI in her original fact sheet.
Defendants kept pushing their right to take ediscovery, and plaintiffs kept resisting. According to defendants, they made blatantly incomplete disclosures and deliberately deleted metadata, in direct defiance of the court’s instructions. Evidence that counsel may have advised plaintiffs – or that plaintiffs may have so understood such advice – to delete or hide ESI led to an in camera review order on August, 2018. One of the founders of the support group left the country and thereafter tried to avoid responding to ESI and other discovery. In October, 2019, the court ordered her deposition and production of ESI.
Actual sanctions started being imposed. SeeIn re Taxotere (Docetaxel) Products Liability Litigation, 2018 WL 4002624 (E.D. La. Aug. 22, 2018) (sanctioning plaintiff that had instructed third-party health care providers to ignore and disobey discovery; evidence of these transgressions being first discovered in that plaintiff’s social media).
She is a sophisticated plaintiff, and she is a representative plaintiff in this litigation. . . . [Plaintiff] knew or should have known that the [fact sheet] required her to disclose [a treater] and the treatment he provided to her. . . . [Plaintiff] has provided no explanation for why she instructed the [hospital] not to release her records. Further, her correspondence with [the treater] about [defendant’s] request for his records demonstrates that she has encouraged at least one other potential witness to be less than forthcoming in this litigation.
Id. at *4. That plaintiff had to pay the defendant’s fees and costs “incurred” due to her discovery breaches, produce “any relevant information” she was still concealing – specifically including all records from the treater in question – and be redeposed “on the evidence she withheld.” Id.
The Court will allow this sanction to serve as a warning . . . to any other plaintiff who might be considering adopting evasive tactics like those discussed in this opinion. If the Court learns that any other plaintiff has intentionally withheld relevant information that should have been produced in a PFS or in response to a request by Defendants, the Court will impose severe sanctions, which may include dismissal with prejudice.
Id.See alsoIn re Taxotere (Docetaxel) Products Liability Litigation, 2018 WL 6697113, at *2 (Mag. E.D. La. Dec. 20, 2018) (denying reconsideration of sanctions against plaintiff who admitted “that her production [of ESI photographs] was less than complete”).
In November, 2018, a new, streamlined protocol to dealing with the many Taxotere plaintiffs who continued to violate PTO 71A was put in place, denominated PTO 85. That order “only applie[d] to PTO 71A and privilege log deficiencies alleged by the Defendants.” Defendants could file deficiency notices within 30 days of the PTO 71A compliance deadline, and plaintiffs had 30 either to “cure the deficiency,” dispute the deficiency, or dismiss their cases. Taxotere PTO 85 ¶3. Telephonic hearings with a magistrate judge are scheduled every 60 days, with sanctions following failure to comply with orders. Id. ¶¶4-1.
The other notable thing that we noticed going through the Taxotere MDL docket was the large numbers of orders dismissing plaintiffs’ cases. There are hundreds, maybe thousands, of them on the docket. This constant flow of dismissals is a strong indication that the defense strategy of making all MDL plaintiffs comply with real discovery requirements is having the desired effect. We know from bitter experience that most MDL cases are garbage, and if those plaintiffs are flushed out and forced to justify their lawsuits, they won’t bother. So, make them work, the earlier the better. Indeed, there have been so many Taxotere dismissals that the court even had to enter a pre-trial order (PTO 87) just to standardize the procedure for plaintiffs filing voluntary dismissals. Ediscovery for defendants in Taxotere thus appears to be playing a significant role in getting meritless cases off of the docket – which is the number one priority of defendants in most mass tort MDLs.