First of all, in response to some comments on our last post, we wanted to close the loop on our dog show narrative. We liked the Wirehaired Fox Terrier, though we have no explanation for the inordinate number of times this breed has won Best in Show (twenty-two, we think we heard). Truth be told, once a dog has won over all of the other entries in its breed, and all of the other breed winners in its group, it is pretty hard for there to be a “wrong” choice. We will say that the Dachshund and the flashy Boxer bitch (featured, by the way, in Netflix’s “7 Days Out” segment on Westminster) showed their hearts out, whereas the Wire seemed a little tired to us. But, unless there is a Standard Poodle (the breed of our heart) among the final seven, we are always happy for whichever gorgeous example of its breed takes the top honor.

In today’s case, federal law takes the top honor. In the Eleventh Circuit’s unpublished decision in Markland v. Insys Therapeutics, Inc., — Fed. Appx. —. 2018 WL 6666385 (11th Cir. Dec. 19, 2018), the plaintiff’s decedent died after being administered the defendant’s pain medication for an allegedly off-label use. The plaintiff filed a wrongful death suit, asserting a single claim for “negligent marketing.” The plaintiff alleged that the defendant engaged in “fraudulent” and “unlawful” marketing to convince doctors to prescribe the drug for off-label uses.

Explaining that, under the FDCA and Buckman, only the United States government may enforce the FDCA’s provisions, the court emphasized that state law tort claims are preempted to the extent that they “seek to privately enforce a duty owed to the FDA.” Markland, 2018 WL 6666385 at *2 (citation omitted).  While the plaintiff in Markland styled his claim as one for “negligent marketing,” the court explained that that is not a recognized tort under Florida law. The plaintiff’s complaint included the allegation that the defendants had “intentionally violated requirements imposed by the FDA” regarding the proper use of the drug.  Id.

The district court had held that the substance of the plaintiff’s complaint was an allegation that the defendant had violated the FDCA, and the Eleventh Circuit agreed. The court held, “A critical premise of [the] complaint is that [the defendant’s] promotion of off-label uses was improper, a proposition that can only be established by pointing to federal law.”  Id.  Moreover the plaintiff did not “point[] to any traditional state-law duty owed by [the defendant] to [the plaintiff’s decedent] that was breached by the company’s marketing of [the drug] for off-label use.”  The court concluded, “It is only because of the FDCA and FDA enforcement decisions that the promotion of off-label uses is prohibited.  Indeed, the very concept of a drug use being ‘off-label’ is derived from the FDCA and FDA policymaking decisions. . . . As with the Buckman plaintiffs, Markland seeks to enforce a duty that exists solely by virtue of the FDCA.  That kind of claim is preempted.”  Id. (internal punctuation and citation to Buckman omitted).

Hornbook stuff, and we like it that way.

Today’s guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities, that being informed speculation on what might be the consequences of a favorable Supreme Court resolution of its currently pending preemption appeal in Merck Sharp & Dohme Corp. v. Albrecht.  We hope he’s right.  As always, our guest posters deserve 100% of the credit (and any blame) for their thoughts published here.  We only provide the forum.

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In Merck Sharp & Dohme Corp. v. Albrecht, the Solicitor General as amicus curiae argues that judges, not juries, are best suited to evaluate the scope of an FDA determination. Brief of the United States as Amicus Curiae Supporting Petitioner, Merck Sharp & Dohme Corp. v. Albrecht, (No. 17-290), 2018 WL 4562163 (filed Sept. 20, 2018).  Judges, he says, “are trained and experienced in construing legal documents and are far better equipped to understand agency decisions in light of the governing statutory and regulatory context.”  Id. at *15.

To support his argument, he cites the Administrative Procedure Act’s statement that a reviewing court shall “determine the meaning or applicability of the terms of an agency action,” 5 U.S.C. § 706, and precedent that has looked to judges to interpret the meaning of prior adjudications.  See id. at 18-20.

While that case has nothing to do with either medical devices in general or 510(k) clearance in particular, Supreme Court agreement with the Solicitor General on this point could radically alter the way courts view the admissibility of 510(k) clearance, at least where Class II devices are concerned.  To gain 510(k) clearance, unless the FDA decides that more is required, the manufacturer need only establish that a new device is as safe and effective as an existing lawfully marketed device.  No other evidence of safety and effectiveness is required in the absence of FDA action.

At present, courts have treated the meaning of 510(k) clearance as a subject for warring expert testimony as to its meaning, as discussed here on the blog (discussing In re Cook Medical, Inc. IVC Filters Mktg., Sales Practices and Prod. Liab. Litig., 2018 WL 6617375 (S.D. Ind. Dec. 18, 2018)).  In other cases evidence of clearance has been excluded, with one explanation being the mistaken theory that the evidence was of such slight probative value that the battle was best avoided.  In re C.R. Bard, Inc. MDL No. 2187, 810 F.3d 913, 922 (4th Cir. 2016). [Ed. note: Other cases, collected and discussed here, admit evidence of FDA device clearance.]

But if the United States Supreme Court decides that preemption issues are treated as purely legal, the courts will be forced to examine the statutory context that controls Class II clearance using 510(k).  That context shows that such a clearance is almost always an FDA “determination” that the device, with whatever special controls that the FDA ultimately imposes, does not present a potential unreasonable risk of illness or injury.  Nothing could be more relevant to a product liability claim.

To begin at the beginning, in 1976 Congress directed the FDA to engage in a sort of regulatory “triage.”  Triage sorts patients according to the seriousness of their injuries and gives them different levels of care.  The FDA’s statutory scheme sorts devices according to the seriousness of the risks they present and requires different levels of premarket review.

More precisely, Congress directed the FDA to engage medical panels to classify medical devices according to their need for regulation.  Congress specified the qualifications the panel members were to have. 21 USC § 360c(b).  The FDA methodically proceeded over the ensuing decades to classify device types into classes I, II or III according to the risk they present.  It convened the panels, held hearings, published panel recommendations, entertained comments from the public, and fixed the classifications.

Devices that present little risk, such as tongue depressors, were put in Class I and do not need FDA review before they are sold to the public.

Moderate risk devices, such as surgical suture, were put in Class II and, if not exempt, must be “cleared” by the FDA before they are marketed.  To gain Class II clearance, the manufacturer must show in a §510(k) submission that they are as safe and effective as an existing Class II legally marketed device that presents a moderate risk.

Finally, devices that may “present a potential unreasonable risk of illness or injury” or are for sustaining life, such as a pacemaker, were put in Class III and generally must be “approved” by the FDA based on extensive independent evidence of their safety and effectiveness.  21 U.S.C. § 360c(a)(1)(C).

On its face, this is a reasonable way to regulate medical devices.  In fact, Congress stated in the statute that it believed this system of classification and review provided “reasonable assurance” of safety and effectiveness for each class of medical device.  21 U.S.C. § 360c(a)(1)(A), (B), (C).

It is encouraging, but not necessary, to observe that the FDA’s sorting of devices seems to have worked.  Even though they receive less FDA scrutiny, “cleared” devices of moderate risk are less likely to result in a serious recall than “approved” devices that may present an unreasonable risk.  One study showed that while 510(k) cleared devices constitute 98% of all devices, they account for only 71% of serious recalls.  And the 2% of devices that are PMA-approved made up 19% of serious recalls.  Jeffrey Shapiro, Substantial Equivalence Premarket Review: The Right Approach for Medical Devices, 69 Food & Drug L.J. 365, 389-390 (2014).

But that is not all. According to the statute, placement in Class II is itself a determination of safety.  If a device is a Class II device, then, with special controls, it usually does not present “an unreasonable risk of illness or injury” that would require it to be in Class III.  21 U.S.C. §360c(a)(1)(C).  The FDA has made that determination based on the initial work of a medical panel and information in the §510(k) which confirmed that the specific device fell within the panel’s classification of the device type.  Otero v. Zeltiq Aesthetics, Inc., 2018 WL 3012942 *3 (C.D. Cal. June 11, 2018).  This can be confirmed when the decision classifying the device type expresses the opinion that there is no unreasonable risk, or uses words to that effect.

In other words, clearance of a moderate risk device using 510(k) is normally a sign of relative safety, even though the FDA review of more risky Class III devices is more rigorous.  That is what the statute says, and experience seems to bear that out.

If the Supreme Court should agree that the interpretation of an FDA decision is a matter of law for the court, then in any case involving a Class II device, the defendant should be entitled to an instruction on the meaning of that decision.

If the FDA decision classifying the device type rests on a finding of no unreasonable risk then, as a matter of law, the defendant should be entitled to an instruction that “The United States Food and Drug Administration has cleared this device for marketing as a Class II device.  That clearance is a determination that there is reasonable assurance of its safety and effectiveness and that, with whatever special controls may have been imposed, the device does not present a potential unreasonable risk of illness or injury.”

Such an instruction would, of course, be radically different from the treatment courts have recently given §510(k) clearance.  Those courts have not only mistakenly allowed juries to decide the meaning of §510(k) clearance, but they have done so in part because of fundamental legal error in the way they have examined §510(k) clearance.

The fundamental error of those courts has been to overlook the distinction between the normal use of §510(k) to clear devices of a type placed in Class II, and the increasingly rare transitional use of §510(k) to clear devices in Class III based on a pre-1976 predicate.

The use of pre-1976 predicates originated in an interim provision Congress adopted in 1976, when the statutory scheme was new. Congress put all implantable devices in Class III as presenting an unreasonable risk pending medical panel review to reclassify them.  Then, anticipating that it would take medical panels a long time to do their work – and has taken more than 40 years – it allowed these devices to be “cleared” using §510(k) if they could be shown to be equivalent to a device on the market in 1976.  This process, unlike the normal use of §510(k), did not involve any medical panel review and did not require equivalence to a classified device.

This increasingly rare scenario was what the Supreme Court addressed in Medtronic v. Lohr, 518 U.S. 470, 477 n.3 (1996), which, quite incorrectly, has been taken as being representative of all FDA clearance decisions.  But it is not. In fact, now that the medical panel reviews of devices with a potential high risk appear to have been almost completed, the scenario is not representative of practically anything that the FDA is still doing today.  See FDA, FDA Has Taken Steps to Strengthen The 510(k) Program 7 (November 2018).

Where a device has been placed in Class II in what is now the ordinary fashion − based on equivalence in safety and effectiveness to a predicate device placed by a medical panel in Class II because its risks are reasonable − that decision, as a matter of simple statutory interpretation, is a determination of safety.  Even if juries are free to disagree with it, they should not be allowed to ignore it. What the Supreme Court tells us in Merck Sharp & Dohme Corp. may have effects far beyond the resolution of the case at hand.

Regular readers of this blog may recall that, each year at this time, we report on our cherished annual trip to the Westminster Kennel Club dog show. This year, the trip was modified at the outset by a work conflict (an argument in Kentucky that we knew we would keep us from attending any part of the first day of the two-day event). We hoped to make it to Madison Square Garden for the Tuesday evening group judging and Best in Show, but that plan was affected (read, “doomed”) Tuesday afternoon by a weather-related flight cancellation. Disappointed, we arranged for our ticket to be re-printed and held at Will Call for a friend who was delighted by the unexpected treat. But then we re-grouped. We figured out that we could make it to the Garden for the last hour, if everything went just right, by taking a still-on-time flight to Philadelphia and a train to New York. We got on the flight as they were closing the boarding door, and ended up standing at the door to the Garden at 9:35 pm. BUT WE NO LONGER HAD A TICKET. And the box office was closed, and Security was unimpressed by our near-tears offer to “pay anything” if we could just get into the building for the last hour. So we hovered outside for a while looking pathetic, and eventually hung our head and headed toward our hotel. Whereupon we encountered a scalper with a ticket for sale. And you can figure out the (very, very happy) ending.

So sometimes it pays to grasp at an unlikely straw when all logical avenues have been exhausted. Not so in today’s case. In Mitchell v. Wyeth Pharms., Inc., 2018 U.S. Dist. LEXIS 220946 (W.D. Tex. Dec. 17, 2018), the plaintiff alleged that her decedent died from complications of taking the generic drug amiodarone for non-life-threatening atrial fibrillation. But amiodarone is a generic drug, and all ordinary product liability claims against generic drugs are preempted. Thus, plaintiff was forced to be creative. Under federal law, pharmacies must provide Medication Guides to patients filling amiodarone prescriptions. The plaintiff’s original complaint, naming both the innovator drug manufacturer and the manufacturer of the generic version, included a claim that the generic manufacturer failed to supply the pharmacy with a Medication Guide that could be provided to the plaintiff. It also included warnings claims and the usual litany of product liability claims. All of the product liability claims were dismissed on the defendants’ predictable preemption motion. The plaintiff filed an amended complaint against the generic manufacturer, asserting only a single substantive claim for failure to provide the required Medication Guide. The defendant moved for summary judgment again, arguing that the uncontroverted testimony established that the pharmacy had been provided with an adequate quantity of FDA-approved Medication Guides along with its amiodarone supply. In response, the plaintiff argued that, beyond sending the Medication Guides to the pharmacy, the manufacturer was required play nanny to pharmacies − to take reasonable steps to ensure that each and every pharmacy actually distributed the Medication Guides to patients − and that the manufacturer had not taken such steps.

The court disagreed, quoting federal regulations that required only that the manufacturer provide enough Medication Guides to the pharmacy (or provide the pharmacy with the ability to print additional copies). The court held, “The text, contrary to Plaintiff’s contention, does not place a duty upon [the manufacturer] to take steps to ensure that the Medication Guides are distributed to patients beyond providing them in “sufficient numbers” to the pharmacy. Mitchell, 2018 U.S. Dist. LEXIS 220946 at *9-10. Nor did FDA regulations require the manufacturer to monitor pharmacies practices to ensure that they were providing Medication Guides when required. In the absence of any evidence that the manufacturer had failed to supply the pharmacy with the required Medication Guides, the court granted summary judgment for the manufacturer. Id.

This is not the first time plaintiffs have tried to force the pharmaceutical industry to superintend the professional practice of pharmacy, and we doubt it will be the last. Bottom line: regardless of the difficulty of imposing liability for injuries allegedly caused by a generic drug, a plaintiff can’t plead around the generic preemption/innovator liability framework by asserting a duty that doesn’t exist. At least under a judge, like the Mitchell judge, who is committed to applying the law correctly. What more can a defendant ask?

 

We’ve reviewed the transcript of the oral argument in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S.), e.g., the United States Supreme Court appeal from the horrible decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), which we ranked as the worst case in all of 2017.  Our one sentence reaction – We’d rather be us than them.

The Fosamax plaintiffs have a lot of problems with their position in Albrecht, chief among them that the FDA itself, as amicus curiae in this case, disputes their interpretation of what the Agency knew and did.

Briefly, plaintiffs argued that:  (1) the FDA’s rejection of the defendant’s “stress fracture” warning was because stress fractures and the injury at issue in the litigation – now called “atypical femur fractures” (or “AFF” for short) − were two different things; (2) the FDA only rejected the imprecise term “stress fracture,” and didn’t reject an AFF warning, and (3) the rest of the regulatory record consists of FDA “musings” that plaintiffs are free to contradict and juries would be free to disregard.  Albrecht Tr. at 35-38, 42-44, 61-63.

Equally briefly, defendant argued that:  (1) its rejected “stress fractures” warning encompassed AFF (a term only created later), demonstrated by language about “complete” and “non-traumatic” fractures; (2) the FDA’s rejection was based on insufficient data about AFF, since a short time later the Agency set up a task force to study AFF before changing labels for this drug class (bisphosphonates); and (3) the FDA does not simply reject scientifically valid warnings for grammatical reasons.  Albrecht Tr. at 3-5, 10-12, 16-19, 65-66.

The FDA, represented by the Solicitor General’s office, agreed with the defendant’s depiction of its regulatory actions regarding AFF, arguing that the Agency obeyed the law and did not reject the defendant’s label for imprecise language, but rather because the link between AFF and bisphosphonates was not supported by sufficient scientific data at the time  Albrecht Tr. at 20-22, 27-30.

At the oral argument another problem for the plaintiffs was evident:  Justice Stephen Breyer.  A member of the majority in Wyeth v. Levine, 555 U.S. 555 (2009), and an anti-preemption dissenter in the more recent PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), decisions, Justice Breyer is a “must get” vote for plaintiffs in Albrecht.  They don’t have him:

JUSTICE BREYER: I’m leading to this, that, when you talk about the standard, drugs are important to people.  They cure millions, or thousands, anyway, of people who need to be cured or helped.

Now, when you put on, and at the same time there will be a smaller subset that can be hurt, so our solution to that is labels.

Now, when you say displacing state law or something, you’re talking like a lawyer, which is what you’re supposed to do, but what worries me is, if you go too far in allowing the tort jury to find mislabeling by not including things, you are hurting the vast majority of − of women here or −or whatever who can benefit from this medicine.

On the other hand, if you don’t go far enough, you will hurt that minority. Now that’s the general framework in which I’m trying to figure out the answer to the question.  And that’s why Justice Gorsuch’s question was − was quite relevant.

All the earmarks here are that Merck took this as a letter saying we’re not certain enough this is really going to hurt people and we don’t want you to put it on.

Now, obviously, somebody must have picked up the phone when they got that letter and they must have phoned somebody in FDA and say:  Do you really mean that? What do you mean?  Because I can change those words, “stress fracture,” in two seconds.  Or do you mean you don’t know enough about it?

Now the appointment of the later task force suggests that they felt they didn’t know enough about it, and, therefore, Merck couldn’t have done it.

Albrecht Tr. at 40-41 (emphasis added).  That wasn’t so much a question as it was a speech, and one that we very much applaud.  But that’s not all.

JUSTICE BREYER: . . .  But what’s actually bothering me about the approach that you’re taking is that, in this particular area, in this particular area of medicines, I don’t really see how we’re going to benefit by 50 different states really giving different signals to the manufacturers, and I can see a lot of ways in which, from a health point of view, we’re going to lose.

That doesn’t mean the law is wrong.  It doesn’t mean − you know, it’s just a question of emphasis. And, here, we have an emphasis.

The next page from the one you cited, the FDA says in 2010, FDA’s review of the data did not show an increase in this risk, the relevant risk, in women using these medications.

So there are indications in this record . . . that they thought that it is more dangerous to put the label − to put the risk in the label than it is to leave it out. . . . And then they set up a task force and decide they were wrong.

Albrecht Tr. at 51-52 (emphasis added) (attempts by plaintiffs’ counsel to get a word in edgewise omitted).

To us defense counsel, these comments by Justice Breyer were the highlight of the argument.

We were also paying attention to Justice Gorsuch, a conservative, but known skeptic of the administrative state, who might not have much deference to the FDA’s actions.  Indeed, Justice Gorsuch had some tough questions for defense counsel about creating a “moral hazard” that might encourage submission of “inartful” warnings, about the availability of unilateral CBE warning changes, and about when “new information” existed.  Albrecht Tr. at 13, 18-19.  But in each instance, counsel provided persuasive answers: (1) that the FDA’s actions belied any such “moral hazard” here; (2) that CBE scientific support standards are identical to the pre-approval process the defendant used; and (3) that new evidence in this instance meant the findings of the FDA task force announced shortly after Agency’s rejection of the warning at issue. Id. at 13-14, 18-19.  If skeptical of the FDA, Justice Gorsuch didn’t show it, not speaking during the SG’s argument. Justice Gorsuch’s later comments, during the plaintiffs’ argument, were clearer:

We have, though, the March 2010 safety statement from the FDA which pretty clearly says that they do not think that there is science enough to support a causal link between the drug and atypical femoral fractures.

So whatever was missing in the complete response letter from the FDA seems to come in March of 2010.

Albrecht Tr. at 34-35.

[T]hat’s why it [the FDA] set up the task force at the same time to go study the issue, and it said up to that point we don’t have enough, but we’re going to go study it. . . . And so why isn’t that − tell us everything we need to know about what its complete response letter was about, as a matter of law?

Id. at 36-37.

As for the two specific holdings that the Third Circuit made in Fosamax – that “clear evidence” means preemption is decided under a “clear and convincing evidence” standard, and that determining what the FDA would have done is a question for the jury – the first was, surprisingly, not mentioned at all. Since plaintiffs abandoned this argument in their briefing, it will be interesting to see what (if anything) the Court holds about the standard of proof. The judge/jury issue received some scrutiny during the plaintiffs’ argument, with plaintiffs backpedaling furiously in response to a question from Justice Alito.:

We agree with Merck that, because of the complete response letter . . . was a legal document that a judge can interpret.  We believe that, based on a sound interpretation of the letter, it doesn’t prove impossibility.

Albrecht Tr. at 58-59.  Then the some other justices got into the discussion, after plaintiffs tried to have it both ways, with the remarkable statement that “the warning that the FDA has to reject has to be adequate to address the risks under state law.”  Id. at 59.  Then was what the FDA had to do a legal question (for the judge) or a factual question (for the jury)?

JUSTICE KAGAN: . . . But that’s the question. And that’s a legal question, is that correct?

[Plaintiffs’ Counsel]: It is a legal that question, but it has factual components.

JUSTICE KAGAN: But a judge can decide that question.

[Plaintiffs’ counsel] : A judge can decide the core legal question, but in all constitutional questions, there are usually fact issues, and we consign those to juries to decide what the fact issues….

JUSTICE BREYER: Not always. There are a lot of mixed issues where, because they’re predominantly legal, the judge does it; patents, for example, Markman [v. Westview Instruments, Inc., 517 U.S. 370 (1996)] is a case of that, and does coerced confessions. I mean, there are a number. . . .  It seems to me that this is in that number because it’s predominantly a legal question and there could be factual disputes on the brute [sic] facts. But, here, I don’t think there are really.

Id. at 59-60 (plaintiffs’ counsel’s attempt to get a word in edgewise omitted). If, in the end, both Justices Kagan and Breyer are skeptical of the idea of preemption/FDA actions as a jury question as they seemed at the oral argument, then the defendant will prevail on this issue as well.

Finally, we’d be remiss not to mention the plaintiffs’ “swing and a miss,” where counsel missed a softball from Justice Sotomayor so badly that the Justice had to provide the right answer:

JUSTICE SOTOMAYOR: Well, we know that the FDA − assuming the theory that the FDA doesn’t believe the label is adequate, what could they have done −

[Plaintiffs’ Counsel]: They could −

JUSTICE SOTOMAYOR:   − absent the study?

[Plaintiffs’ Counsel]: They –

JUSTICE SOTOMAYOR: Meaning because the study obviously changed the FDA’s mind. You’re saying, you, [defendant], could have done it.

[Plaintiffs’ Counsel]: Yes. . . .

Albrecht Tr. at 57.  When that happened to Rick Perry, his response was “Oops.” At least counsel recovered to answer the question more thoroughly.

Justice Ginsburg was absent, and Justice Thomas, as usual, asked no questions.  The usual split would have Justice Ginsburg voting against preemption and Justice Thomas voting for it.

Anyway, we’re not in the business of predicting Supreme Court results. But all in all, after the oral argument, I’d much rather be on our side than not.

This isn’t the first time, but the Blog has a problem with its reporting on cases decided in the ongoing “Opioid” litigation.  As lawyers, our first obligations are to our clients, and in this instance some of our clients in the opioid litigation don’t want us talking about their cases.  So when that happens, we don’t.

That doesn’t mean that we aren’t looking for ways to help, but it can’t be through reporting on what went down in individual cases.  We can do concepts, however. That’s why we have been particularly intrigued with one aspect of the recent opioid decision in Floyd v Feygin, 2018 WL 6528728 (N.Y. Sup. Dec. 6, 2018), that dismissed the plaintiff’s “negligence” claim.  The defendant (not a RS client) in Floyd successfully argued the following:

In support of its motion, [defendant] argues that plaintiff’s negligence cause of action against it is, in effect, an attempt to privately enforce the Controlled Substances Act. [Defendant] asserts that plaintiff lacks the authority to regulate its conduct in this regard or to enforce the Controlled Substances Act since Congress has committed enforcement of the Controlled Substances Act exclusively to the Attorney General and the Department of Justice.

Id. at *5. Thus the defendant argued that this “negligence” claim was preempted.  Id.

As we discussed earlier, the Floyd court agreed that the Controlled Substances Act (“CSA”) could not be used in this way, because there isn’t any private right of action:

It has been held that pursuant to its plain terms, the [CSA] is a statute enforceable only by the Attorney General and, by delegation, the Department of Justice.  Based on the regulatory structure of the [CSA] federal courts have uniformly held that the [CSA] does not create a private right of action.  The manufacture, distribution, and dispensing of opioids is comprehensively regulated by the [CSA], and the DEA is the primary federal agency responsible for the enforcement of the Controlled Substances Act.

Id. (citing: Schneller v Crozer Chester Medical Center, 387 F. Appx. 289, 293 (3d Cir. 2010); Smith v Hickenlooper, 164 F. Supp.3d 1286, 1290 (D. Colo. 2016), aff’d, 859 F3d 865 (10th Cir. 2017); McCallister v Purdue Pharma L.P., 164 F. Supp.2d 783, 793 (S.D.W. Va. 2001); DEA, Practitioner’s Manual, at 4 (2006)) (citations and quotation marks omitted).  Further, the New York equivalent of the CSA likewise carried with it no private right of enforcement. Id. at *6 (discussing 10 N.Y.C.R.R. Part 80).

Because the CSA provided no means of private enforcement, its requirements could not create novel common-law duties that did not otherwise exist.

[P]ursuant to both the [CSA] and New York State regulations, [defendant’s] sole duty with respect to its manufacture and distribution of opioids was to collect and record data, and make reports to federal and state agencies.  Although these regulations define circumstances that trigger reports to federal or state agencies, there is nothing within these regulations that requires a manufacturer to stop or restrict its distribution of opioids. . . .  Thus, [defendant] had no duty to control the prescribing, dispensing, and use of its [drug].

Id. at *6 (citations omitted).

The rationale in Floyd – that a federal statute’s lack of a private cause of action preempts a common-law plaintiff from using its requirements to create a “duty” – is what Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), is all about.  Curiously, Buckman is nowhere cited in Floyd, although Buckman’s implied preemption principles are applicable to all similarly situated federal statutes.

Which raises the question – how much can we “Buckmanize” the CSA, replacing the FDA with the equivalent federal authority of the “Attorney General?  Buckman, of course depended on statutory designation of the FDA as the sole enforcer of the FDCA. So we looked through the CSA looking for similar designations. We found:

21 U.S.C. §811(a), which governs scheduling of the substances to be “controlled”:

The Attorney General shall apply the provisions of this subchapter to the controlled substances listed in the schedules . . . and to any other drug or other substance added to such schedules under this subchapter.

21 U.S.C. §821, which governs enforcement generally:

The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals.

21 U.S.C. §822(a), which governs registration of manufacturers and distributors generally:

(1) Every person who manufactures or distributes any controlled substance . . . shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.

(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him.

21 U.S.C. §823(a-b), which governs requirements imposed through registration

The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest. . . .

The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest.

Section 823 is particularly interesting because it also permits the federal government (through the attorney general) to register “practitioners” – that is, physicians – and contains a limited anti-preemption savings clause:

Notwithstanding section 903 of this title, nothing in this paragraph shall be construed to preempt any State law that . . . requires a qualifying practitioner to comply with additional requirements relating to . . . reporting requirements.

21 U.S.C. §823(l). Section 823 thus is further support for Buckman-type preemption arguments by manufacturers and distributors, since Congress only preserved state-law reporting requirements imposed on “practitioners,” but does not allow state law to impose reporting requirements on manufacturers or distributors of controlled substances.

21 U.S.C. §825(a), regarding labeling:

It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label . . . containing an identifying symbol for such substance in accordance with such regulations.

21 U.S.C. §825(c), regarding drug warnings:

The Secretary shall prescribe regulations under section 353(b) of this title which shall provide that the label . . . contain[s] a clear, concise warning that it is a crime to transfer the drug to any person other than the patient.

The “secretary” refers to the HHS and thus the FDA.  See 21 U.S.C. §802(24). Section 825(c) thus seamlessly integrates federal enforcement authority.  Go directly to Buckman; do not pass “Go.”

21 U.S.C. §826(a, b), governing amounts of controlled substances it is legal to make:

The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance. . . .

. . .[U]upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances . . . that the manufacturer seeks to produce.

21 U.S.C. §827(b, d-e), dealing with reporting requirements:

Every inventory or other record required . . . shall be in accordance with, and contain such relevant information as may be required by, regulations of the Attorney General, . . . and [] shall be kept and be available . . . for inspection and copying by officers or employees of the United States authorized by the Attorney General.

Every manufacturer registered . . . shall, at such time or times and in such form as the Attorney General may require, make periodic reports to the Attorney General of every sale, delivery or other disposal by him of any controlled substance, and each distributor shall make such reports with respect to narcotic controlled substances. . . .

[E]ach manufacturer registered . . . shall, with respect to narcotic and nonnarcotic controlled substances manufactured by it, make such reports to the Attorney General, and maintain such records, as the Attorney General may require. . . .  The Attorney General shall administer the requirements of this subsection. . . .

That’s a lot of “attorney general” references, thus further demonstrating that Floyd reached the correct result.  It seems very clear from the statute that reports about controlled substances are not the kind of thing that states have traditionally required or administered.

21 U.S.C. §830(a-b), imposing record-keeping and additional reporting requirements:

(1) Each regulated person who engages in a regulated transaction . . . shall keep a record of the transaction for two years after the date of the transaction.  (2) . . . Such record shall be available for inspection and copying by the Attorney General.  (3) . . . The Attorney General shall specify by regulation the types of documents and other evidence . . . for purposes of this paragraph.

(1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation–(A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this subchapter. . . . A regulated person may not complete a transaction . . . unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guidance documents describing transactions and circumstances for which reports are required. . . .

Again, all reports are to the federal government, about information specified by the federal government, and subject to the approval of the federal government.

21 U.S.C. §843, concerning fraudulent reporting:

It shall be unlawful for any person knowingly or intentionally . . . to furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made. . . .

In addition to any penalty provided in this section, the Attorney General is authorized to commence a civil action. . . .

Who can sue over fraudulent reporting to the Attorney General? The federal government.

21 U.S.C. §871(b), regarding the role of the Attorney General generally:

The Attorney General may promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter.

21 U.S.C. §880(b), concerning inspections of regulated facilities:

[T]he Attorney General is authorized, in accordance with this section, to enter controlled premises and to conduct administrative inspections thereof. . . .  [E]ntries and inspections shall be carried out through officers or employees (hereinafter referred to as “inspectors”) designated by the Attorney General.

21 U.S.C. §882(c), providing for state enforcement against internet pharmacies:

[T]he State may bring a civil action on behalf of such residents in a district court of the United States with appropriate jurisdiction. . . .  No private right of action is created under this subsection.

In this rare instance where the CSA authorizes independent state enforcement, the statute specifically prohibits a private right of action.

21 U.S.C. §902, preserving the FDCA:

Nothing in this chapter, except [additional reporting requirements to the Attorney General, and prescription restrictions] shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act.

Nothing in the CSA impairs the basis for Buckman preemption.

21 U.S.C. §903, concerning “field” preemption:

No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field . . ., to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.

States can enforce their own laws against illegal drugs.  Notably, this savings clause expressly limits its scope to “field” preemption, and does not address other types of implied preemption, such as Buckman or “purposes and objectives” preemption.  To avoid preemption, the “subject matter” of the state law must be “otherwise within the authority of the State,” which would seem to preclude ad hoc imposition of reporting requirements on interstate commerce.  No private right of action is provided.

Probably the provision of the CSA that is most analogous to Buckman’s 21 U.S.C. §337(a) is §871(b) concerning the Attorney General’s general authority, but as we’ve detailed above, a lot of other CSA provisions reject private enforcement or specify federal enforcement.  Thus, as did the court in Floyd, we think that the structure of the CSA fully supports a preemption rationale, similar to Buckman, that because there is no private right of CSA action, would be private enforcers of the CSA – and in particular its reporting requirements to the federal government – are preempted from doing so under state law.

We’ve always hated the Ninth Circuit’s decision in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (applying Arizona law), holding that allegations of failure to provide adverse event reports (“AERs”) to the FDA created a viable, and unpreempted, state law claim.  Now our #2 worst case of 2013 is effectively gone.  Kaput.

Today the Arizona Supreme Court in Conklin v. Medtronic, Inc., No CV-17-0322-PR, slip op. (Ariz. Dec. 18, 2018), expressly – and unanimously − disagreed with Stengel’s misinterpretation of Arizona product liability warning law, and since the Arizona Supreme Court is “supreme” on state-law issues, Stengel is invalid.  We’ll get directly to the good stuff:

We disagree with Stengel. . . .  In Stengel, the Ninth Circuit held that the [Medical Device Amendments] did not expressly or impliedly preempt the plaintiffs’ Arizona common law failure-to-warn claim based on Medtronic’s alleged failure to submit adverse event reports to the FDA.  That holding, however, was based on the unsupported premises that “Arizona law contemplates a warning to a third party such as the FDA” and that, “[u]nder Arizona law, a warning to a third party satisfies a manufacturer’s duty if . . . there is ‘reasonable assurance that the information will reach those whose safety depends on their having it.’”  Neither premise comports with Arizona law. . . .  [E]stablished law does not recognize a claim merely for failing to provide something like adverse event reports (which may not qualify as “warnings” under Arizona law) to a government agency that has no obligation to relay the information to the patient.

Because Stengel incorrectly recited and applied Arizona law, we decline to follow it. . . .  [O]ur case law contemplates that a medical device manufacturer may satisfy its duty to warn consumers by properly warning a third party, such as a learned intermediary.  But the FDA is not a learned intermediary or other relevant third party in that analysis.  And we are not aware of any case that supports the proposition that a manufacturer is independently required under Arizona law to warn a governmental regulatory body.

Slip op. at 10 ¶¶30-31 (citations omitted) (emphasis added, except for final emphasis, which is original).  Put the red flag on Stengel.

So how did the Conklin court reach this exemplary conclusion?  The path begins with an excellent preemption ruling in the trial court, Conklin v. Banner Health, 2015 WL 10688305 (Ariz. Super. Oct. 30, 2015), in a case involving a pre-market approved infusion pump.  That decision held all negligence per se claims (including the failure to report claim at issue here), preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  The intermediate Arizona appellate court reversed preemption of the failure to report claim, following Stengel.  See Conklin v. Medtronic, Inc., 418 P.3d 912, 919 (Ariz. App. 2017).  A further appeal produced today’s opinion.

The Arizona Supreme Court first recognized that, contrary to Stengel, there is no presumption against preemption in express PMA preemption cases.  “[A]lthough federal laws are presumed not to preempt state laws, courts do not invoke that presumption when the federal statute contains an express preemption clause.”  Slip op. at 3 ¶8 (citations and quotation marks omitted).  Interestingly, though, Conklin ultimately based its decision mostly on implied, not express, preemption, id. at 7 ¶21 (finding duty-to-report claim impliedly preempted and not reaching express preemption), so the presumption against preemption didn’t really figure in the result.

Conklin also utilized the “narrow gap” metaphor to describe the interaction of express preemption and implied preemption in PMA device cases:

Read together, these two types of preemption, operating in tandem, have created a “narrow gap” for pleadings.  To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violates that federal requirement (avoiding implied preemption).

Slip op. at 6 ¶18 (citations and quotation marks omitted).

The one aspect of the plaintiff’s duty-to-report claim that Conklin held to be expressly preempted was the assertion that the FDA was obligated to make AERs widely available to the public.  Federal law did not require that, so:

[T]o the extent [plaintiff] argues that the FDA either has or assumed a duty to convey information from adverse event reports to treating physicians, patients, or more broadly public consumers . . ., [that] claim is expressly preempted because it likewise would impose under state law a requirement that is “different from, or in addition to,” any applicable federal requirement.

Id. at 6 ¶20 (regulatory citations omitted).

The broader implied preemption ruling was based, as indicated above, on the absence of any reporting duty owed under state law.  Conklin “assume[d] without deciding” that AERs could be “warnings” under state law, but several “but cf.” citations indicated its disinclination to so rule.  Slip op. at 7 ¶22. The learned intermediary rule, which the court previously adopted in Watts v. Medicis Pharm. Corp., 365 P.3d 944 (Ariz. 2016) (we discussed Watts here and here), proved to be key.  Under Arizona law, prescription medical product warnings need only go to learned intermediaries, and the FDA didn’t qualify as a “learned intermediary.” Arizona’s learned intermediary rule “only extends . . . to prescribing and other health-care providers.”  Slip op. at 8 ¶26. There was never any state-law obligation to warn the FDA:

The FDA is not a health care provider and does not prescribe anything for patients. . . .  Accordingly, even if we assume that adverse event reports may constitute relevant warnings, Arizona law does not permit a manufacturer to satisfy its duty to warn end-user consumers by submitting adverse event reports to the FDA.  And conversely, a manufacturer does not breach its duty to warn end users under Arizona law by failing to submit adverse event reports to the FDA.  [Plaintiff] cites no authority, and we are aware of none, for the proposition that Arizona law requires a manufacturer to warn a federal agency.

Id. at 8 ¶¶26-27 (citations omitted).  The duty to warn in Arizona “has not been extended to require a manufacturer to submit warnings to a governmental regulatory body.”  Id. at 8 ¶28.  Submitting AERs to the FDA does not provide “reasonable assurance” that such information “will reach end users (or end users’ health care providers) because the FDA is not required to publicly release such reports.”  Id. at 9 ¶28 (citations omitted).

Thus, the lack of any Arizona state-law duty to report was fatal to plaintiff’s reporting-based claims.  While Conklin held that such claims don’t exist from the outset, the case was litigated and appealed on preemption grounds.  Thus followed the preemption ruling that plaintiff’s purported reporting claims were purely FDCA-related, and thus preempted under Buckman:

Because only federal law, not state law, imposes a duty on [defendant] to submit adverse event reports to the FDA, [plaintiff’s] failure-to-warn claim is impliedly preempted under 21 U.S.C. § 337(a).  Absent an independent state law duty to submit adverse event reports to the FDA, [plaintiff’s] failure-to-warn claim, at bottom, is an attempt to enforce a federal law requirement.  That claim is impliedly preempted under the MDA.

Slip op. at 9 ¶29 (Buckman citations omitted).

Then came the slicing, dicing, and pureeing of Stengel that we quoted at the outset.  Conklin closed by dispatching the other cases plaintiff relied on, thus performing the additional service of highlighting the questionable validity of Fiore v. Collagen Corp., 930 P.2d 477 (Ariz. App. 1996).  See Id. at 11 ¶33 (Fiore “adopted a minority view . . ., and in any event likely does not survive Riegel”).

On this blog, we have declared, until we are blue in the face, that it is a usurpation of state court power for a federal court sitting in diversity to make up new theories of liability under state law.  That’s what Stengel did, and thankfully, in Conklin, the state high court thereby bypassed by the Ninth Circuit’s novel ruling had both the opportunity and inclination to call out the trespassing federal court.  Once again:

We disagree with Stengel. . . . Stengel incorrectly recited and applied Arizona law.

Slip op. at 10 ¶¶31-32.

Mic drop.

We opposed the FDA’s ill-advised 2013 proposal to revamp the process for changing generic drug labeling from the outset.  We had legal objections – that an FDA regulation could not alter the statutory “sameness” requirement imposed on generic labeling.  We had practical objections – that the change was a sop to the plaintiffs’ bar, intended primarily to reduce generic preemption in civil litigation, rather than to pursue any legitimate FDA objective.  And we had procedural objections – that FDA had secretly colluded with the plaintiffs’ bar in coming up with the proposal.

We were hardly the only ones to object, and the proposal was repeatedly deferred.  Once the proposal was postponed until after the 2016 election, we pronounced it dead.  Either the Ds would win, and approach the preemption issue directly by changing the makeup of the Supreme Court (Mensing/Bartlett were 5-4 decisions), or the Rs would win and the FDA would stop carrying water for the plaintiffs’ bar.

The latter happened, with [fill in the blank] consequences for the country and the world, but with predictable consequences for the FDA’s generic labeling proposal.  After a reasonable interval, the FDA formally put an end to the lingering 2013 proposal last week.  Here is the bottom line, from a December 13 statement posted on the FDA’s website:

In November 2013, the FDA proposed a rule . . ., which, if finalized, would have allowed generic drug makers to independently – meaning, without prior FDA review and approval – update and promptly distribute new safety information in drug labels. This is something that currently only branded drug makers can do.

This rule, if implemented, would have allowed generic manufacturers to independently update their drug labels with new information. We heard from manufacturers that they believed this change would have imposed on them significant new . . . liabilities. We heard arguments that the proposed rule could impose new costs on generic manufacturers that might have raised the price of generic drugs. . . . And, among other challenges, the new policy would have resulted in labels for the same drug that varied between different generic manufacturers, for some period of time. This could have led to consumer and provider confusion.

Today, the FDA is withdrawing this proposed rule. . . .

Dick Tracy signing off!  The bottom line is that, after five years, nothing has changed, particularly the scope of and basis for generic preemption.  Nor will there be any change to the FDA’s requirement of agency preapproval to changes to the “highlights” section of branded drug labeling – another potential source of preemption in civil litigation (this isn’t mentioned in the FDA statement, but is discussed in the accompanying Federal Register notice).

This agency coup de grâce is accompanied by the usual regulatory word salad about “ensur[ing] that generic companies continue to engage in an appropriate level of post-market safety surveillance” and “hurdles that – if the rule was implemented – could compromise public health.”  The FDA admitted:

[A]dditional or different warnings [could] temporarily appear in generic drug labeling compared to the brand drug – depending on the availability of information to various manufacturers and the timing of updates.  Such differences, even if temporary, could undermine confidence in generic drugs and their therapeutic equivalence.  We understand that the proposed rule may have also led to confusing, conflicting generic labels that were crowded with redundant safety information. Individual generic manufacturers might have added additional and at times superfluous information to their individual labels to avoid the risk of liability for failure to warn.

This, of course, is a problem hardly limited to generic drugs.  Competing branded drugs have all of these issues, too, which is one reason that the FDA frequently imposes class-wide labeling. There’s a solution for it – called “Expedited Agency Review” (“EAR”) – that would involve the FDA at an earlier stage in all labeling changes to ensure that this kind of chaos from occurring.  EAR was proposed as an alternative to the 2013 proposal, but is not mentioned in the FDA’s statement, probably because it would require “additional resources and help from Congress.”

The FDA’s statement does contain a useful clarification of the responsibility for labeling changes, after a branded “reference listed drug” is withdrawn from the market:

If the brand drug manufacturer has voluntarily withdrawn their marketing application, generics that reference the brand medicine can still be approved and marketed.  But the brand drug manufacturer is no longer responsible for making any necessary label updates that generic applicants can follow.

See also Federal Register Notice.  We add emphasis to this statement, since today is also the first anniversary of T.H. v. Novartis Pharmaceuticals Corp., 407 P.3d 18 (Cal. 2017), a case in which the California Supreme Court failed to recognize this basic fact.

More information on the withdrawal of the FDA’s 2013 generic labeling proposal is available at 83 Fed. Reg. 64299 (FDA Dec. 14, 2018)

The FDA has recently released a proposed rule “to establish requirements for the medical device De Novo classification process” provided in 21 U.S.C. §360c(f)(2).  FDA, “Medical Device De Novo Classification Process,” 83 Fed. Reg. 63127 (Dec. 7, 2018).  This de novo classification option is a relatively recent addition to the FDCA (via the 1997 FDA Modernization Act), and provides:

(ii) In lieu of submitting a report under section 360(k) [a/k/a/ §510(k)] . . ., if a person determines there is no legally marketed device upon which to base a determination of substantial equivalence . . ., a person may submit a request under this clause for the Secretary to classify the device.

(iii) Upon receipt of a request . . ., the Secretary shall classify the device subject to the request under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) [meaning Class I, Class II, or Class III] within 120 days.

(iv). . . .

(v) The person submitting the request for classification under this subparagraph may recommend to the Secretary a classification for the device and shall, if recommending classification in class II, include in the request an initial draft proposal for applicable special controls, as described in subsection (a)(1)(B), that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.

360c(f)(2)(ii-v) (emphasis added).  The emphasized statutory language establishes the standard to which these “de novo” devices are held: “reasonable assurance of safety and effectiveness.”  That’s important to preemption because of what Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had to say over twenty years ago:  “provid[ing] the FDA with a ‘reasonable assurance’ that the device is both safe and effective[,] [d]espite its relatively innocuous phrasing . . ., is a rigorous one.  Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews.”  Id. at 477.

Famously, Lohr also declared that the 510(k) substantial equivalence process “[t]he 510(k) process is focused on equivalence, not safety.”  Id. at 493 (emphasis original).  That is certainly cannot the case with de novo devices, since by definition there is no equivalence determination to be made.  Indeed, the FDA “may decline to undertake a classification request submitted under clause (ii) if [it] identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence.”  21 U.S.C. §§360c(f)(2)(iv).

We’ve expounded at great length in our “Lohr Has Two Shadows” post about how Lohr had been an anachronism ever since it was decided because Congress toughened up the original 510(k) process that Lohr addressed with the Safe Medical Devices Act of 1990.  The SMDA imposed the same “reasonable assurance of safety and effectiveness” standard on substantial equivalence determinations that Lohr had praised as “rigorous in Lohr.  See 21 U.S.C. §§360c(a)(1)(B), 360c(f)(1)(A)(v).

Nevertheless, since Lohr, the judiciary has engaged in a conspiracy to ignore the SMDA and treat all 510(k) medical devices as if they were evaluated under minimalistic standard that the Supreme Court addressed in 1996.  With de novo devices, it’s going to be a lot harder for judges to continue sticking their heads in the sand and chanting “Lohr, Lohr, Lohr” every time a non-PMA device is at issue.

The FDA’s proposed rule makes clear that the de novo process is essentially the SMDA’s “special controls” regime without the fig leaf of substantial equivalence:

The De Novo classification process provides a pathway to ensure the most appropriate classification of a device consistent with the protection of the public health and the statutory scheme for device regulation. This pathway is intended to limit unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to a PMA due to a lack of a predicate.

83 Fed. Reg. at 63129 (emphasis added).  No longer can the SMDA standard for clearance of Class II devices be dismissed as involving “equivalence, not safety.”  It’s the same “rigorous” standard that Lohr equated with PMA – only extended to other classes of devices, in particular:

For any class II recommendation, the De Novo request must also provide an initial draft of proposed special controls along with a description of how the special controls provide reasonable assurance of safety and effectiveness.

Id. at 63130.

The proposed regulations firmly establish that de novo devices are to be evaluated for “safety and effectiveness,” not equivalence, in practically every aspect of their FDA review:

  • “If the submitter recommends that the device be classified as class II, FDA proposes that the recommendation must include a draft proposal for applicable special controls, and a description of how those special controls provide reasonable assurance of safety and effectiveness of the device.”  Id. at 63133.
  • “FDA proposes that the De Novo request include reference to any published standard relevant to the safety or effectiveness of the device.”  Id.
  • “For a clinical investigation involving human subjects, FDA proposes to require that a discussion of . . . safety and effectiveness data, adverse reactions and complications, patient discontinuation, patient complaints, device failures . . . and replacements. . . . FDA would use the summary of investigations in assessing safety and effectiveness of the device.”  Id.
  • Valid scientific evidence is evidence . . . from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.”  Id. at 63133-34.
  • “The proposed benefit and risk considerations section would expressly require that, “pursuant to the determination of safety and effectiveness section of the regulations, a discussion be included demonstrating that . . . the probable benefit to health from use of the device outweighs any probable injury or illness from such use (i.e., a discussion demonstrating the safety and effectiveness of the device) when the device is used according to its labeling.”  Id. at 63134.
  • “Any safety and effectiveness data to assist FDA in assessing whether the clinical investigation supports that a reasonable assurance of safety and effectiveness exists. FDA would assess reasonable assurance of safety and effectiveness by evaluating the valid scientific evidence submitted to support the De Novo request. FDA would review the data to assess whether the data supports the claims made in the indications for use and demonstrates that the probable benefits of the device outweigh the probable risks.”  Id.
  • “Discussion of data on any adverse reactions to the use of the device . . . or complications related to the use of the device. . . . Frequency data and severity data are particularly useful in safety and effectiveness determinations. FDA would review the rates of complications in clinical investigations in assessing the safety and effectiveness of the device.”  Id.
  • “FDA would need all discontinuation data in order to determine the safety and effectiveness of the device.” Id.
  • “Trends in complaints may point to possible risks posed by the device. FDA would review such trend analyses in assessing the safety and effectiveness of the device.”  Id. at 63135.
  • “In analyzing failures, factors such as location, user application, and repeat component failures may apply. FDA would review such analyses in assessing the safety and effectiveness of the device.”  Id.
  • “Statistical analysis of the results from each clinical investigation. The statistical analysis should specify and discuss all effects. FDA would review such analyses in assessing the safety and effectiveness of the device.”  Id.
  • Any “contraindication, precaution, warning, or other limiting statement relevant to the use of the device. . . . This includes information regarding any special care to be exercised by a practitioner or patient for the safe and effective use of the device.”  Id.
  • “[I]f a De Novo request relies primarily on data from a single investigator at one investigation site, the De Novo request must include a justification showing why these data and other information are sufficient to demonstrate the safety and effectiveness of the device.”  Id.
  • “FDA further proposes to require that a De Novo request include a discussion of the clinical significance of the results, pursuant to the determination of safety and effectiveness.”  Id.
  • “FDA proposes to require that the De Novo request include any other identification, discussion, and analysis of any other data, information, or report relevant to the safety and effectiveness of the device.”  Id.
  • “FDA proposes that the De Novo request must include other information that is necessary for FDA to determine whether general controls or general and special controls provide a reasonable assurance of safety and effectiveness of the device. Examples would include marketing experience outside the United States, medical device reporting (MDR) data . . ., and patient preference information.”  Id. at 63136.
  • “FDA proposes to require the De Novo requester to update its pending De Novo request with new safety and effectiveness information . . . as such information becomes available.”  Id.
  • “FDA proposes that FDA would be able to inspect relevant facilities prior to granting or declining a De Novo request. Such an inspection is intended to assist FDA in determining whether a reasonable assurance of safety and effectiveness can be provided by general or general and special controls.”  Id. at 63137.

Emphasis added in all cases.  Once all of these safety/effectiveness requirements are complied with, the FDA would issue an “administrative order” granting the request and specifying the de novo device’s classification.  Id.  By such orders “FDA would determine the safety and effectiveness of the device using the criteria specified in the determination of safety and effectiveness section of the regulations.”  Id. (citing 21 C.F.R. §§860.289(d), 860.7).

Given the proposed regulations’ emphasis on determinations of device “safety and effectiveness” throughout, as well as its reliance on “special controls” customized to each de novo request, we think that de novo devices should be protected by preemption under Lohr and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We have here device-specific requirements intended “to provide reasonable assurance of safety and effectiveness” of these devices

Oddly, there is no explicit discussion – or even mention – of “preemption” in the FDA’s proposed rule.  So that nobody ends up buying a pig in a poke, we advise that industry-side comments to this proposal should request the FDA to specify explicitly that it believes the de novo process provides preemptive protection under 21 U.S.C. §360k(a), for all products that the FDA concludes have “reasonable assurance of safety and effectiveness” under 21 U.S.C. §360c(f)(2), and in accordance with Lohr‘s analysis .  While, in the past, FDA opinions on preemption haven’t always been helpful, or even intelligible, this time it might be.

That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof. Twerski’s Wikipedia page is the fifth result when we just Googled that phrase).  Prof. Twerski, one of the ALI’s reporters for the Restatement (Third) of Torts:  Products Liability, has probably spilled as much ink as anyone in making sense of Restatement (Second) of Torts §402A, comment k (1965), one of the more opaque parts of the venerable §402A.  Indeed, in a prior article, Prof. Twerski divined fully eight different interpretations of comment k, the Second Restatement’s discussion of, among other things, design defect claims involving prescription medical products (mostly drugs and vaccines, as medical devices were much less common back in 1965).  See James A. Henderson, Jr. & Aaron D. Twerski, “Drug Design Liability: Farewell to Comment K,” 67 Baylor L. Rev. 521, 542-44 (2015).

Then there’s the Third Restatement, which sought to replace comment k’s approach to design defect claims involving “unavoidably unsafe” products with:

§6 Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices

*          *          *          *

(c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Restatement (Third) of Torts, Products Liability §6(c) (1998).

As we’ve chronicled on the blog, most courts still continue to grapple with comment k.  Conversely, §6(c) has received a mixed and tepid response from the courts.  Now Prof. Twerski has essentially concluded that further explication of the courts’ Talmudic approach to comment k and design defect claims in our sandbox is futile – such claims are all federally preempted.  That, of course, is something we’ve been saying on the Blog since the moment Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), was decided five years ago.  See, e.g., here, here, here, and here.  But we’re just bloggers; Prof. Twerski is an institution.  We’re flattered simply to be cited as authority on par with law reviews and other scholarly works.  See footnotes 6 & 19.

Here’s a link to Prof. Twerski’s latest article on SSRN.  Its formal citation is, 68(1) Am. Univ. L.R. 281-304 (2018).  The first thing we note about the article is that the title is limited to “drugs,” as opposed to medical devices.  Nothing in the article, however, expressly distinguishes medical devices, and Prof. Twerski concludes that the limited cause of action permitted by Restatement (Third) §6(c) – which treats prescription drugs and medical devices identically – is, indeed, preempted:

The Restatement test ultimately allows a common law design defect claim to prevail over the FDA’s approval of a drug.  The only thing that a defendant can do to escape liability is to stop selling the drug − a position that is in direct contravention of Bartlett.  Perhaps for a drug that is so egregiously dangerous, the Supreme Court might craft an exception to Bartlett.  But, otherwise, the Bartlett dissent is quite correct in predicting that the majority has rendered drug design defect immune from common law actions.

“Demise of Drug Design Litigation,” 68(1) Am. Univ. L.R. at 302 (footnotes omitted).

As we’ve pointed out on a number of occasions, most recently in our discussion of Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1 (1st Cir. 2018), the Mensing/Bartlett basis for impossibility preemption – that the FDA must pre-approve “major changes” to product designs, and therefore regulated manufacturers cannot act immediately and unilaterally to change “defective” designs, as state tort law requires − applies equally to design changes for both drugs and medical devices.

Interestingly, we also note that Prof. Twerski speculated that the Gustavsen preemption decision – then in the district court (the First Circuit decision was too recent to be in his article) – might be within “a small subset of design claims [that] may not be preempted.”  68(1) Am. Univ. L.R. at 303.  Prof. Twerski’s reasoning was “that the Supreme Court might take issue with the FDA characterization of a change in volume of the drops created by the bottle’s stopper as a ‘major change’ requiring FDA approval.”  Id.  Well, the First Circuit affirmed preemption of “major changes,” and it doesn’t seem like the plaintiffs in Gustavsen are as optimistic about their case as Prof. Twerski’s supposed they might be.  They did not bother appealing to the United States Supreme Court, and the deadline for doing so has expired.

Another interesting perspective offered by Prof. Twerski is that Bartlett was improperly decided – not on preemption, but as a matter of New Hampshire state law.  68(1) Am. Univ. L.R. at 284.  The Court in Bartlett held, as to New Hampshire product liability law:

But respondent’s argument conflates what we will call a “strict-liability” regime (in which liability does not depend on negligence, but still signals the breach of a duty) with what we will call an “absolute-liability” regime (in which liability does not reflect the breach of any duties at all, but merely serves to spread risk).  New Hampshire has adopted the former, not the latter.  Indeed, the New Hampshire Supreme Court has consistently held that the manufacturer of a product has a “duty to design his product reasonably safely for the uses which he can foresee.”

570 U.S. at 481 (string citation of New Hampshire cases omitted).  Prof. Twerski’s analysis, turning on a case Bartlett did not cite, Vautour v. Body Master Sport Industries, Inc., 784 A.2d 1178 (N.H. 2001), posits, instead, that in Vautour New Hampshire product liability became “absolute liability” based on pure risk/utility balancing, without any need for the plaintiff to assert an alternative design.

This is not the forum to rehash our strong objection to [absolute liability].  The point is that New Hampshire has embraced it.  Thus, liability was not regulatory in the sense that Justice Alito set forth in Bartlett.  New Hampshire did not impose a duty on [defendant] to develop a better warning nor did it require [defendant] to redesign [the drug].  It simply allowed a jury to find that the [drug], as designed with the warnings as given, was unreasonably dangerous.

68(1) Am. Univ. L.R. at 292-93 (footnotes omitted).

Pointing to the footnote in Bartlett (570 U.S. at 482 n.1) “sav[ing] for another day” the issue “whether a true absolute-liability state-law system could give rise to impossibility pre-emption,” Prof. Twerski suggests that Bartlett should have come to grips with the application of impossibility preemption to an absolute liability system of product liability.  68(1) Am. Univ. L.R. at 293-94.  We think that Bartlett actually did address absolute liability, perhaps back-handedly, in its discussion of the plaintiff’s claim that the defendant should never have sold its FDA-approved product.  What is that theory, if not absolute liability?  Liability, under a stop-selling theory seems pretty “absolute” to us, since the only way to avoid liability would be not to sell the product at all. Bartlett had no trouble holding that theory preempted:

The incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases.  In every instance in which the Court has found impossibility pre-emption, the “direct conflict” between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting. . . .  Adopting the First Circuit’s stop-selling rationale would mean that not only [Mensing], but also the vast majority − if not all − of the cases in which the Court has found impossibility pre-emption, were wrongly decided.  Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in [Mensing], so it is irrelevant to our analysis here.

570 U.S. at 488-90 (detailed description of particular cases omitted).

So, did Bartlett mess up New Hampshire law?  Prof. Twerski makes a pretty convincing case as to what New Hampshire law actually is, but ultimately we don’t think it makes much difference.  First, we think that the majority in Bartlett was not interested in deciding the case based on New Hampshire having some sort of bats**t crazy tort regime, but rather wanted to emphasize preemption of more mainstream forms of product liability.  Second, nothing in Bartlett, and in particular in its affirmance of “stop-selling” preemption, indicates that absolute liability would escape the fate of other, more widely accepted, design defect liability theories.

Ultimately, Prof. Twerski concurs in that assessment.  Pure risk/utility balancing amounts to a definitively preempted stop-selling claim:

Can the state allow a common law remedy based on a finding of unreasonable danger, thus negating the FDA’s determination that the drug is reasonably safe so that it is approved for marketing? . . .  After running out of state common law duties to make the drug safer, the defendant was left with the sole option of not marketing a FDA approved drug to avoid tort liability.  This remaining option, however, is an option that Bartlett teaches flies in the teeth of preemption jurisprudence.

68(1) Am. Univ. L.R. at 300-01 (footnotes omitted).

Second, the most widely followed design defect rationale – risk/utility balancing of reasonable alternative designs (“RAD”) is precisely what Bartlett preempted:

[P]ost-Bartlett, it would seem quite clear that, for a drug that has received FDA approval, any argument that it can be modified by a RAD is federally preempted.  Justice Alito’s reasoning leaves little doubt when he said that “once a drug − whether generic or brand name- − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug.”’  If a court were to find a post-FDA approval drug to be a RAD, it would almost certainly be struck down on the same impossibility grounds set forth in Bartlett.

Id. at 295 (footnotes omitted).

Third, Prof. Twerski (like us) has only scorn for the “pre-approval design defect” theory that plaintiffs have turned to as an argument to avoid preemption.

How a court could censure a manufacturer for not developing a different drug without any assurance of its safety by the FDA is beyond comprehension.  As to preemption, the court in [Mensing] made short order of the argument that a plaintiff could challenge an FDA approved drug based on the supposition of what the FDA might do if asked to respond to a change. . . .  None of the cases opting for the “pre-approval theory” have adequately responded to either the common law or preemption arguments that negate this novel theory.

Id. at 296-97 (footnotes omitted).

Finally, as already discussed, the design defect theory enshrined in Restatement (Third) §6(c) also runs afoul of preemption.  Id. at 302 (footnote omitted).

Thus, Prof. Twerski concludes that design defect claims involving prescription drugs are preempted no matter how the plaintiffs package them.  In the end, however, Prof. Twerski sheds no tears over the demise of design defect litigation against FDA-approved drugs.  Design-based theories have never really amounted to very much:

The overwhelming majority of cases against pharmaceuticals have always been based on failure to warn. . . . Drug design, despite the fascination of scholars with this issue, has played only a minor role in drug litigation. The pillars of the republic will not fall if this questionable theory is laid to rest.

Id. at 304. That’s a sentiment with which we whole-heartedly agree.  We are always interested in reading more of Prof. Twerski’s views on design defect preemption – particularly with respect to prescription medical devices.

As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?”  Leftovers are as much of an American tradition on this day as watching videos of altercations during frenzied early holiday shopping. Both celebrate wretched excess in their own way. Some leftovers, however, can be combined to create something tasty and worthwhile. Other leftover uses should not be attempted. We would put sandwiches of turkey, stuffing (dressing down South), and cranberry goop in the former category and Brussels sprouts omelets in the latter.

A while back, for a few years, we chronicled a real turkey of a case called Howard. The saga is recounted here, where the plaintiff’s expert was finally kicked for the unreliability of his defect opinion about the PMA device at issue in the case. Along the way, the case generated two notably foul (fowl?) opinions. Deciding on preemption in the context of a theoretical claim, the Sixth Circuit held that a negligence per se claim could be a parallel claim and avoid express preemption.  Years later, on a referred question, the Oklahoma Supreme Court okayed a negligence per se claim under Oklahoma law based on violations of the FDCA.  That gobbler took home the ribbon for third worst of 2013.  Our well-documented view that there can be no negligence per se claims based on violations of the FDCA notwithstanding, Oklahoma now has a claim that came from a case that was soon to be plucked and exposed as lacking merit.

A few years later, the plaintiffs in Cantwell v. De La Garza, No. CIV-18-272-D, 2018 WL 5929638 (W.D. Okla. Nov. 13, 2018), sued an implanting orthopedic surgeon, non-profit health care system, and medical device manufacturer for alleged injuries from the alleged off-label use of a PMA medical device in a spinal surgery. The manufacturer moved to dismiss. We do not have many details of the underlying facts or allegations, but we are focusing on the negligence per se claim—the leftover from the Howard turkey, in case you missed our less-than-subtle theme. A few weeks before the Oklahoma Supreme Court’s decision in Howard, the Western District of Oklahoma rejected the purported parallel claims in Caplinger. After a motion to reconsider was denied, the Tenth Circuit affirmed in Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), one of our favorite preemption decisions and a 2015 winner.  In part because that decision was authored by future Justice Gorsuch, we have drilled down on Caplinger a few times and tracked its impact.

The Cantwell plaintiffs claimed that the manufacturer had promoted the device to be used off-label—it was approved for use in the thoracolumbar spine, but was used in the cervical spine—and that violated apparently unspecified provisions of the FDCA and its regulations. Under the Oklahoma Supreme Court’s decision in Howard, “To establish negligence per se, the plaintiff must demonstrate the claimed injury was caused by the violation [of a statute], and was of the type intended to be prevented by the statute . . . [and] the injured party [was] one of the class intended to be protected by the statute.” Pretty much the hornbook definition, along with the requirement that the plaintiff prove breach, causation, and damage. In the context of pleadings and the Howard decision, the court went back to basics. Plaintiffs did not plead a particular statute or regulation that had been allegedly violated, let alone that could be tied to the injuries attributed to the device at issue. Howard did not lower the pleadings bar: “The court said nothing to suggest, however, that a plaintiff wishing to bring such a claim could proceed without identifying the statute or regulation allegedly violated, and thus the duty allegedly breached by the defendant’s conduct.” Looking to Caplinger and the unaddressed but obvious issue of preemption, the court noted that “such identification is particularly important in the area of medical devices, where a state-law negligence claim must survive the FDCA’s provision of a federal preemption device.” So, no identified allegedly violated federal statute or regulation meant no properly pleaded claim for negligence per se. Citing to the FDCA in general or invoking the loaded term “off-label” was not enough to get past a motion to dismiss. Predictably, though, the dismissal was without prejudice, so we expect plaintiffs will try again. If they do, then we would not be surprised if Justice Gorsuch’s former colleagues on the Tenth Circuit get another chance to weigh in on express preemption with a re-heated version of Howard.