The last time we wrote about vaccines, we received a lot of emails.  Vaccines are a hot-button issue for some, although we firmly believe they should not be.  Vaccines have prevented disease in millions and millions of people and are among the most important public health developments of all time.

When we wrote that post in 2019, we had no idea that vaccines would come to dominate global headlines, prompted by the COVID-19 pandemic.  Let’s be clear:  We think everyone who is able should be vaccinated.  If you have genuine questions, talk to a medical professional, not a TV personality or politician (from any party).  And by all means, do not at this point say you have a Constitutional right to refuse vaccination.  Because you don’t.  And that has been established for more than 100 years.

That is what a group of students at Indiana University learned when they recently moved for a preliminary injunction against a state university’s mandatory vaccine policy, and lost.  The case is Klaassen v. Trustee of Indiana University, No. 1:21-cv-238, 2021 U.S. Dist. LEXIS 133300 (N.D. Ind. July 18, 2021), and the 42-page order is among the most thorough and thoughtful orders on which we have written.

The University’s policy was not an impulsive decision.  The University convened a committee spearheaded in part by the Dean of the Medical School and populated by experts in medicine, public health, risk mitigation, law, and ethics.  Id. at *13-*14.  That process resulted in a policy requiring all students, faculty, and staff to be vaccinated before returning to campus.  Id. at *15.  The consequences are real—those who do not comply are essentially banned from campus.  But there are also multiple exemptions granted on a no-questions-asked basis, including religious exemptions, medical exemptions, medical deferrals, and exemptions for online enrollees.  Id. at *16.  The committee was also not writing on a clean slate.  Indiana has required that all public university students be vaccinated for multiple diseases since 1993.  Id. at *10.

What could be wrong with this?  Well, the students argued that the mandatory policy violated their right to substantive due process under the Fourteenth Amendment, which says that no state can “deprive any person of life, liberty, and property, without due process of law.”  Id. at *39.  “Substantive due process” means that the Fourteenth Amendment furnishes “an additional guaranty against any encroachment by the States upon the fundamental rights [that] belong to every citizen.”  Id. (quoting United States v. Cruikshank, 92 U.S. 542, 554 (1875)).  In other words, substantive due process is a “substantive limitation on the power of government to legislate.”  Id. at *40.

The standard of review is critical in substantive due process cases, and this case was no exception.  The students argued that they had a “fundamental right” to refuse vaccination, which triggered strict scrutiny.  Strict scrutiny is the highest level of constitutional scrutiny, under which the government’s infringement must be “narrowly tailored to serve a compelling state interest.  Id. at *41-*42.  In practice, a governmental body almost always loses under a “strict scrutiny” test.

The University, however, argued that neither the right to refuse vaccinations nor the right to a college education were fundamental.  As a result, any infringement on those rights should be judged under rational basis review, under which legislation is “presumed to be valid and will be sustained if the classification drawn by the statute is rationally related to a legitimate state interest.”  Id. at *42.  In practice, a governmental body almost always wins under when “rational basis” is the test.

The district court applied rational basis review, relying on the Supreme Court’s opinion upholding a smallpox vaccine mandate more than 100 years ago in Jacobson v. Massachusetts, 197 U.S. 11 (1905).  Although Jacobson, did not use the words “rational basis review,” the district court found that the Supreme Court applied rational basis review in all but name:

Though Jacobson was decided before tiers of scrutiny, it effectively endorsed . . . rational basis review of a government’s mandate during a health crisis.  . . . [¶]  This view remains consistent with the right at stake in Jacobsonthough a true “liberty” proved at stake—the right to refuse a vaccine during a smallpox epidemic—this interest in bodily autonomy, though protected by the Constitution, wasn’t fundamental under the Constitution to require greater scrutiny than rational basis review.

Id. at *54-*55 (emphasis added).  The district court also harmonized this holding with the Supreme Court’s more recent holding in Roman Catholic Diocese v. Cuomo, 141 S. Ct. 63 (2020), where the Supreme Court applied strict scrutiny to enjoin New York from imposing COVID-19 restrictions on religious services.  Id. at *51-*55.  In Cuomo, the right at stake—the right to religious worship—was a fundamental right.  Different ballgame.

Applying rational basis review, the district court upheld the University’s mandatory vaccine policy.  It came down to a balance of the students’ liberty against the relevant state interests, i.e., protecting public health:

“Stemming the spread of COVID-19 is unquestionably a compelling interest.”  Cuomo, 141 S. Ct. at 67 (majority opinion).  . . .  Recognizing today’s status of this pandemic, neither health professionals, government representatives, nor this court may say public health vis-à-vis COVID-19 has waned from being a legitimate state interest.  Improved it undoubtedly has—today seems a world altogether different from last year—but public health remains a legitimate interest of the state to pursue.

Id. at *68.  The students argued that their liberty interest weighed favorably against this government interest because “the pandemic is basically over.”  Id.  But the court quickly rejected that argument:  “Vastly improved, yes; out of the woods we aren’t, not on this record.”  Id. at 69.  The court was right, and how, as recent developments have only underscored.

The court also reminded the parties why the COVID-19 situation has improved—because of vaccines!  And it emphasized that the situation remains fluid, with virus variants being moving targets.  Id. at *70-*72.  The balance satisfied rationale basis review—the University has a rational basis to conclude that the COVID-19 vaccines are safe and efficacious, and its policy reasonably relies on the vaccine to prevent disease and “return to normal school functioning.”  Id. at *100.  As the court observed,

[W]hen reasonable minds can differ as to the best course of action—for instance, addressing symptomatic versus asymptomatic virus spread or any number of issues here—the court doesn’t interfere so long as the university’s process is rational in trying to achieve public health. . . . There is a rational basis for making distinctions here.

Id. at *103-*104.  Finally, the students who received vaccine exemptions—six of the eight plaintiffs—challenged the accompanying requirements that they wear masks and submit test result.  The court found no Constitutional deprivation there, either.  Neither implicates a fundamental right, and the requirements are rationally related to promoting health and safety.  Id. at *107-111.  Both vaccinated and unvaccinated people can still get the virus, and students have lived with mask mandates for more than a year.  There was nothing unreasonable about it.  Id. at *111-*113.

In the end, the unvaccinated students thought it was all about them, but they could not be more wrong.  “[T]he evidence reasonably shows that [unvaccinated people] aren’t the only ones harmed by refusing to get vaccinated: refusing while also not complying with heightened safety precautions could ‘sicken and even kill many others who did not consent to that tradeoff.’”  Id. at *116-*117 (emphasis added).

And that really is the point.  The recalcitrance of the few unavoidably impacts the many, if not through infection and death, then at least through the imposition of social distancing, masking (mandatory or otherwise), and other common-sense measures that the many would rather not endure.  These students correctly lost, although we suspect others will try.  Unfortunately.

A federal court has asked the supreme court of Washington to address the scope of that state’s learned-intermediary doctrine. In particular, it has asked whether Washington recognizes a “direct-to-consumer” exception to the doctrine.

Under the learned-intermediary doctrine, which has been adopted by every state other than West Virginia, a manufacturer of a prescription medical product satisfies its duty to warn of the risks associated with the product if it provides adequate warning to prescribing physicians. In short, manufacturers of prescription medical products must warn doctors, not patients.

The doctrine’s rationale is straightforward:  Medical products available only by prescription have complex risk-utility profiles that are difficult for lay persons to evaluate. Trained in medicine, familiar with the medical history of individual patients, and legally obligated to obtain informed consent before administering a treatment, doctors are best positioned to warn individual patients of the relevant risks in an intelligible manner.

Given that rationale, the doctrine is generally limited to prescription medical products—i.e., products that can be lawfully obtained only through a doctor. Accordingly, it typically does not apply to over-the-counter products.

Over the years, plaintiffs have sought to limit the doctrine even further, arguing that it should not apply when the manufacturer markets a prescription medical product directly to consumers. With the lone exception of New Jersey, no state that recognizes the doctrine has restricted it in that way. That makes sense. Even if a prescription product is advertised to potential patients, it still can be obtained only through physicians, who have the knowledge and duty to convey the relevant warnings to their patients.

Granting a plaintiff’s motion to certify the question, a federal district court has now asked the Washington supreme court whether that state’s learned-intermediary doctrine applies when a prescription medical product is marketed to potential patients. Although it recognized that “[t]he vast majority of state courts that have considered the issue have concluded that … the ‘learned intermediary’ doctrine should apply” in such situations, it concluded that the issue has sufficiently “far-reaching public policy and legal implications” to warrant certification of the question. Dearinger v. Eli Lilly & Co., 2021 WL 2805328 (W.D. Wash. 2021).

State supreme courts commonly agree to answer certified questions. It is not clear, however, whether Dearinger actually implicates the certified question. Although the drug at issue, Cialis, is marketed to consumers, the plaintiff is challenging the adequacy of its FDA-approved patient-information insert rather than the manufacturer’s consumer marketing. If the state supreme court accepts the certified question, we should know its answer later this year or early next.

A month ago we thought our country had turned the corner on Covid-19. Not so. The plague continues. Bad show, America. We’re sick of Covid, sick of reading about Covid, sick of the controversies, sick of the deprivations, and, most of all, sick of all the disease and death. We won’t say we’re sick of writing about COVID, because we’ve mostly left that to others. When the tongue of history tells the final tale of Covid, we suspect it will be a catalogue of human errors, with occasional hiccups of heroism and ingenuity.

Covid implicates science more than law, but we are lawyers and we know how to stick to our lane. (That is an out and out lie, of course. At the drop of a hat or mask we are happy to bloviate ignorantly and loudly about Covid lockdowns and anti-vaxxers.) Just as with public health measures, legal responses to Covid have had a mixed, perhaps mostly bad, track record in contending with Covid. Depressingly stupid laws have been passed and predictably silly lawsuits have been filed.

But the Public Readiness and Emergency Preparedness (PREP) Act was a singularly sensible response to Covid. We have written about the PREP Act before, but for a quick refresher, recall that the PREP Act provides that “a covered person shall be immune from suit and liability under Federal and state law with respect to all claims for loss caused by, arising out of, related to or resulting from the administration to or the use by an individual of a covered countermeasure if the [Secretary of Health and Human Services has issued a declaration permitting the administration of that covered countermeasure.]”. In a major health emergency, you don’t want hesitancy based on fears of liability. Ah, but how will the PREP Act be enforced in cases where things go wrong and all the sympathy goes to the injured party?

Cannon v. Watermark Retirement Communities, Inc., 2021 U.S. Dist. LEXIS 133613, 2021 WL 3033762 (E.D. Pa. July 19, 2021), is an interesting PREP Act decision from the Eastern District of Pennsylvania. It is also another example of the courts letting plaintiffs chip away at the ostensibly broad preemption that the Act and the HHS directives created.

Instead of suing over a nursing home patient catching COVID, the decedent here had COVID and was treated for it with an “experimental” drug combination, hydroxychloroquine and doxycycline. The estate alleged that the family was concerned about the experimental treatment because it was not FDA approved and had a history of causing heart problems, and that the decedent’s son explicitly declined to consent to the experimental treatment. The estate also contended that the treatment was not permitted to be used either outside of a hospital or on asymptomatic patients. But it was administered here just the same. Following this treatment the decedent allegedly “deteriorated” and died. The estate of the decedent brought a wrongful death and survival action against the senior community for negligence, negligence per se, and reckless and outrageous conduct.

The defendant senior community filed a Rule 12(b)(6) motion to dismiss based on PREP Act immunity. The court denied the motion to dismiss, reasoning that the treatment was not a “covered countermeasure” under the PREP Act because FDA’s emergency authorization was limited to persons who were hospitalized with COVID, and the decedent was never hospitalized. Thus, according to the court, the experimental treatment did not “fall within the clear, explicit, and limited scope of the drug’s FDA emergency use authorization.” That sounds almost like a presumption of non-immunity.

The defendant argued that PREP Act immunity also applies to the “misuse” of a covered countermeasure. The court disagreed because it interpreted “misuse” to be limited to nonuse or omission. What happened in Cannon was an affirmative misuse, not a nonuse or omission. We’re not sure this distinction makes sense either in terms of statutory interpretation or underlying policy, but there it is.

The defendant’s final defense was invocation of the PREP Act’s safe harbor provision, which extends immunity to circumstances in which a covered countermeasure was administered by someone who reasonably could have believed that the countermeasure was being used appropriately. The court held that on a motion to dismiss, where all inferences must be drawn in favor of the plaintiff, the court could not conclude that the defendants reasonably believed it was administering a covered countermeasure because the PREP Act’s definition of the “population” was unambiguous and the decedent fell outside it – she was neither hospitalized nor determined to be eligible for clinical trials.

It will be interesting to see whether the defendant in Cannon can make out facts supporting a reasonable belief that the countermeasures were appropriate. We wouldn’t be surprised if they ultimately do so. But in the meantime, the case goes on, with discovery and all the other expensive machinery of civil litigation. It is possible that the aims of the PREP Act are not being well served.

What happens when a plaintiff from Kentucky sues a New York company in Massachusetts?  The case gets tossed for lack of personal jurisdiction.  That is exactly what happened in Kingston v. Angiodynamics, Inc., 2021 WL 3022320 (D. Mass. Jul. 16, 2021).  It is what should have happened in Hammons v. Ethicon, Inc., 240 A.3d 537 (Pa. 2020), but instead that case was No. 1 on our list of worst decisions in 2020.  Fortunately, Massachusetts does not have the same open arms policy for litigation tourists that Pennsylvania does.

Plaintiff – who lives in Kentucky, had surgery in Kentucky, and who alleges to have suffered his injuries in Kentucky – sued the manufacturer of the catheter system implanted in him for the administration of chemotherapy medications.  Kingston, at *2.   The defendants are a parent and subsidiary company both of which are incorporated in Delaware.  Id. at *3.  The parent corporation is headquartered in New York where all executive level employees are located and all significant corporate decisions for both the parent and subsidiary are made.  Further, the individuals who carry out work for the subsidiary in the United States are all employees of the parent company.  Id.

Against this set of facts, the court was asked to decided plaintiff’s motion to remand based on her argument that defendants were forum defendants thereby defeating diversity jurisdiction and defendants’ motion to dismiss based on lack of personal jurisdiction.  Plaintiff’s motion was denied and defendants’ was granted.

The question of diversity turned on whether or not defendants could be considered to have a principal place of business in Massachusetts making them citizens of the state.  The court found it did not matter which test was used to determine where defendants’ principal place of business was – “nerve center test;” “center of corporate activity test;” or “locus of operations test.”  The result was the same.  Defendants’ principal place of business was New York.  Id.  As for the parent, plaintiff tried to argue that it had some employees in Massachusetts.  They were not high-level executives or corporate officers, and merely having employees in a location is not enough to make that location a principal place of business.  Id. at *4.  For the subsidiary, plaintiff tried to argue that it at one time had a principal place of business in Massachusetts, but even if that were true, it is undisputed that the company was purchased by its current parent years before the device at issue was implanted in plaintiff.  The subsidiary-defendant is wholly owned by the parent defendant and plaintiff offered no evidence to refute that the corporate decisions for the subsidiary are now made by the parent in New York.  Id.  Nor was it relevant to this issue that some FDA correspondence was addressed to the Massachusetts location or that defendants’ CEO owns a house there.  Massachusetts is a lovely place to own property.  Because defendant is not a citizen of Massachusetts, it had the right to remove the case to federal court and the motion to remand was denied.

Not surprisingly, most of the principal place of business discussion is directly relevant to the personal jurisdiction inquiry as well.  The court first examined the Massachusetts long-arm statute which allows the state to exercise jurisdiction over an individual who “transacted business in Massachusetts” where the plaintiff’s claim arises from the transaction.  Both factors must be satisfied.  Id. at *5.  The “arising from” requirement is essentially a “but for” causation test.  Id.  Again, plaintiff relied on the presence of some employees in the state, including some who work in research and development.  But that is not enough to support an assertion that plaintiff’s injury would not have occurred “but for” defendant’s activities in Massachusetts.  Corporate decisions were made in New York and the product was manufactured in New York.  Id. at *6.  Without an adequate nexus between plaintiff’s injuries and defendants’ in-state activities, she did not meet the requirements of the long-arm statute.  Id.

The court then moved on to general jurisdiction – where a defendant’s contacts with the state are so “continuous and systematic” as to render them at home in the forum state. Id.  For all the reasons previously discussed, defendants were not “at home” in Massachusetts and therefore, there is not general jurisdiction.  Id.

Finally, plaintiff argued the court should exercise specific jurisdiction over defendants.  Specific jurisdiction is only available “where the cause of action arises directly out of, or relates to, the defendant’s forum-based contacts.”  Id. at *7.  Plaintiff tried to rely on Ford Motor Co. v. Montana Eight Jud. Dist. Ct., ___ S. Ct. ___, 2021 WL 1132515, at *4 (U.S. March 25, 2021) but the court focused on the same distinction we focused on when we posted about that case Plaintiffs in Ford sued in their home jurisdictions:

Unlike here, the plaintiffs there were residents of the forum states, used the allegedly defective products in the forum states and suffered injuries when those products malfunctioned in the forum states.

Id.  In Kingston, plaintiff’s surgery took place in Kentucky during which a product manufactured in New York by a company headquartered in New York was implanted.  Additional surgery and alleged complications also occurred in Kentucky.  The fact that defendants had some research and development and regulatory affairs departments in Massachusetts is not sufficient to establish specific jurisdiction.  Defendants’ alleged contact with Massachusetts is neither “an important or material element of proof.”  Id.  at *8.  Because plaintiff could not demonstrate that defendant’s in-forum activities gave rise or related to her injury, she could not establish specific jurisdiction.  Id.

Plaintiff asked for leave to conduct jurisdictional discovery, but the court found that her allegations, even if proven, were too attenuated to state a colorable claim and therefore discovery would be futile.  Id. at *8-9.  All claims dismissed.

Still more Zantac MDL dismissal orders.

Today’s installment grants dismissal of the plaintiffs’ medical monitoring claims, and also sheds some light on the questionable factual basis of everything being asserted in this MDL.  As we’ve pointed out in our prior posts (such as this one), plaintiffs allege that the active ingredient in this drug could break down into an alleged carcinogen, particularly in warm or moist environments.  However, N-Nitrosodimethylamine (“NDMA”), the allegedly harmful breakdown product at issue, is ubiquitous, and anyone who consumes bacon, beer, or cheese has likely been exposed over the years to higher doses from these other sources.

That matters for medical monitoring claims, as In re Zantac (Ranitidine) Products Liability Litigation, 2021 WL 2682659 (S.D. Fla. June 30, 2021), demonstrates.  This Zantac decision booted most of a “master” class action complaint seeking medical monitoring and other purported economic losses.  Plaintiffs sought to create a litigation castle in the sky (no less than 638 counts) with a great many would-be classes (divided up by state and by defendant) in five general categories:  medical monitoring against branded manufacturers of prescription products; medical monitoring against branded manufacturers of over-the-counter (“OTC”) products; medical monitoring against generic manufacturers; medical monitoring against “store brand” sellers; and medical monitoring against “store brand” manufacturers.  Id. at *3.

Since many members of these putative classes undoubtedly took more than one of these products, some going back more than two decades, and many were without prescription, how plaintiffs would prove their respective exposures to each – an essential element of any medical monitoring claim − strikes us as entirely speculative.

Secondarily, plaintiffs filed a “consolidated, amended consumer economic loss class action” described as an action by 180 named plaintiffs:

in their individual capacities and on behalf of numerous classes . . . under various state laws stemming from the Defendants’ sale of prescription-strength ranitidine for approximately forty states.  Additionally, the Plaintiffs bring state class actions under approximately forty-three states’ laws for the Defendants’ sale of OTC ranitidine.

Id. at *4 (footnote omitted).  Another castle in the clouds.  We addressed the RICO aspects of this complaint here.

The preliminary skirmish on medical monitoring was whether two of the states as to which plaintiffs chose to bring claims – Indiana and Montana – would recognize a medical monitoring recovery by otherwise uninjured plaintiffs.  Unfortunately, a nearly 30-year-old intermediate appellate court in Indiana had allowed such a claim, Gray v. Westinghouse Electric. Corp., 624 N.E.2d 49 (Ind. App. 1993), so the defendants lost on Indiana.  2021 WL 2682659, at *8.  There being no equivalent support for medical monitoring in Montana, the court went with Erie conservatism and dismissed all the Montana monitoring claims with prejudice for failure to state a claim.  Id. at *9 (refusing to “expand[] Montana law in the manner that the Plaintiffs suggest”; “On no interpretation of Erie of which we are aware may a decision by a state trial court be credited as determining the law of the state”) (citation and quotation marks omitted).

The real fun begins with consideration of the “plausibility” of plaintiffs’ medical monitoring claims.

Although “[t]he law of medical monitoring varies across jurisdictions,” id. at *10, such “non-traditional torts” share several essential elements in common:  (1) exposure to a hazardous substance above normal levels; (2) in a threshold amount; (3) sufficient to create a significant increase in risk of a serious health condition; (4) for which medical monitoring exists that would facilitate early exposure; (5) which is different than routine medical testing anyone should get.  “[S]ome states require that testing procedures exist to detect diseases early, while others do not.”  Id. (discussing, inter alia, Florida law).

Plaintiffs’ claims failed, first, on the issue of “significantly increased risk.”  Id. at *11-12.  The “significant risk” analysis “raises two distinct questions.”  Id. at *12.  “First, . . . how much NMDA must a Plaintiff be exposed to before the Plaintiff has a significantly increased risk of cancer? Second, how much NDMA exposure have the Plaintiffs alleged?”  Id.  Plaintiffs’ verbose and Brobdingnagian complaint botched both prongs.  “Plaintiffs have failed to clearly plead just how much exposure the Plaintiffs received and how much exposure is needed to warrant the remedy of medical monitoring.”  Id.

The basic question is how much exposure to NDMA is allegedly the threshold exposure for “significant” increased risks of “cancer.”  Plaintiffs’ opposition papers used 3,000 nanograms (“ng”), but they did not clearly allege that as the threshold exposure for a “significant” cancer risks in the complaint itself.  Id.  Instead, they “alleged that the consuming of 96 ng each day, for seventy years, results in a .001% increase in the risk of cancer.”  Id. (emphasis added).

.001%?  Give us a break.  That’s entirely trivial.  1% is one in a hundred – so .1% is one in a thousand; .01% is one in ten thousand, and .001% is one in one-hundred thousand.  These plaintiffs are seeking test 100,000 people on the off-chance of detecting one early cancer, with no assurance that such testing would actually improve anyone’s prognosis.  And seventy years?  Zantac didn’t come on the market until 1981, and not one of the now over 20 Zantac MDL opinions mentions anything about pediatric use.

Nor do plaintiffs’ allegations account for “cancer” being anything but monolithic, but rather a catch-all term for a variety of metastatic conditions having different etiologies and tests for detection.

Only in an MDL would plaintiffs even think about making such absurdly overbroad allegations.  We offer, in contrast, our post, here, on punitive damages, requiring a “substantially certain” risk of harm.  The Zantac claims aren’t even in the same ballpark.

Fortunately this MDL judge doesn’t seem to be drinking the plaintiffs’ Kool-Aid.  Understandably the Zantac court required that “if the Plaintiffs equate a .001% increased risk with a significantly increased risk, then the Plaintiffs should clearly make that argument.”  Id.

The next point was how much NDMA exposure was actually alleged − from background consumption and allegedly from taking Zantac or generic ranitidine.  Once again, plaintiffs’ complaint fell short.  Like we’ve pointed out in our posts, “every human being consumes NDMA through eating, drinking, and even breathing.”  Id.  According to studies plaintiffs themselves cited, the background rate – “daily NDMA consumption levels” on the high end, was 510 ng/day in one study, 191 ng/day in another, and 179 ng in a third.  Id.  That’s from nearly two, to over five, times as much as the 96 ng/day rate that plaintiffs impliedly asserted could cause “significant” cancer risk (if taken daily for a lifetime).  Id.  In other words, background NDMA exposure significantly exceeds exposure allegedly caused by defendants’ products, according to plaintiffs’ own studies.

And it gets worse.

Plaintiffs’ argued for a purported “3,000 ng of NDMA per-dose” – that is, per Zantac/ranitidine pill – but that allegation was nowhere to be found in their 2,192-page complaint.  Id. at *4.

And it gets worse.

The chief study cited in plaintiffs’ complaint about alleged per-pill amounts of NDMA simply is no more.  “[A] red retraction notice appears on the top of the study.”  Id. (emphasis added).  As the opinion dryly puts it, “[i]f the Plaintiffs’ position is that the Court may conclude that the Plaintiffs have plausibly alleged a claim for medical monitoring based upon a retracted study, the Plaintiffs should clearly argue and explain that position.”  Id.

A second, even wilder, estimate – that each pill contained over 2,000,000 ng of MDMA – also bore no relationship to reality:

[T]he Court has been able to locate an allegation that each [drug] dose contained over 2,000,000 ng of NDMA. That number [was . . . arrived at . . . by heating [the drug] to 266 degrees Fahrenheit.  Pursuant to the Plaintiffs’ allegations, however, the temperature of the human body is 98.6 degrees, not 266 degrees.

Id. (emphasis added).  Even during the hottest day in the hottest place (Death Valley) in the recent record heat waves, the temperatures did not get within 100° of that temperature.  For obvious reasons, “the Court does not conclude that a test utilizing 266 degrees of heat plausibly establishes a significantly increased risk of cancer.”  Id.

Another hypothesis was that the drug breaks down in the stomach at body temperature (≈98.6°F) in the presence of food containing sodium nitrite.  Is that biologically plausible?  In a word, no.

In the absence of an explanation or context from the Plaintiffs, the Court endeavored to understand what, mathematically and scientifically, [the necessary amount] of sodium nitrite means.  The Court attempted to perform its own mathematical calculations to discern the amount of bacon necessary to collect [that amount] of sodium nitrite in the human stomach.  The Court’s own calculations estimated the amount of bacon to be necessary at around 25 pounds.

Id. at *15 (footnote omitted).  That’s another purported per dose calculation.  So, to reach the threshold exposure, all a putative class member would have to do is take each pill with food – 25 pounds of bacon per pill – and repeat each day for 70 years.

Although this scientific discussion takes place in Zantac in connection with estimating increased risk in the context of medical monitoring, the larger picture is also emerging – the plaintiffs’ increased risk calculations are generally unrealistic and wildly inflated.  It will be very difficult for them to get out of that hole.  The court suggested that they begin that attempt by “provid[ing[ context and explanation” for their numbers in any amended complaint that they subsequently file.  Id.

Good luck (not).

Because “[f]ourth and finally, the Court has been able to locate allegations about the amount of NDMA in [the drug] from tests performed by the FDA.”  Id. at *15.  The FDA’s unbiased testing once again severely undercuts plaintiffs’ numbers while simultaneously demonstrating variability that should be fatal to any putative class action:

The amount of NDMA found in the [the drug] was not equal across the Manufacturing Defendants. . . .  One Defendant’s [product] tested as having zero. . . .  Even if the Court were to utilize the highest amount of NDMA found by the FDA (360 ng) and assume that every Defendant’s ranitidine had that much NDMA, that number is still an order of magnitude lower than the 3,000 ng number argued in the Plaintiffs’ response.

The Court addresses one final point about the FDA’s findings.  In the FDA’s own words, the “NDMA levels FDA found are similar to the levels a consumer would expect to be exposed to when eating common foods like grilled and smoked meats.”

Id. (citations omitted) (emphasis added).  As mentioned above, medical monitoring in any state requires significant exposure above background levels.

And we’ve only covered the problems with plaintiff’s allegations concerning exposure per pill.

Plaintiffs likewise fail to allege plausibly the “frequency” of their exposures – that is, how often they took pills.  The Zantac complaint vaguely references “therapeutic doses.”  Id. at *16.  What’s that?  Plaintiffs’ pleading ensures that nobody knows.  They allege only that individual “[p]laintiffs “ingested [the drug] at various times as part of their treatment.”  Id.

Very enlightening.  That their 2,000+ page complaint lacks such basic information strongly suggests they can’t plead it – at least not in any form that could conceivably support class-wide proof.

There is no allegation as to the frequency of use, nor is there a reference to “therapeutic dosages.”  The Plaintiffs’ alleged class definitions similarly do not assist the Court, because the Plaintiffs define the class as being anyone “who used” ranitidine without qualification.

Id. at *16.  This is why we headlined this post with the “wheels coming off” the Zantac litigation – a combination of self-evidently fabulist general dosage calculations and utterly absent individual information concerning frequency of use.  Plaintiffs’ allegations wouldn’t even pass muster in asbestos litigation.

They get to try again, but this will be their third round of pleadings.  We hope “strike three” means “yer out”:

Plaintiffs may, of course, plead a substantial increase in the risk of cancer in whatever way they deem best, including through avenues other than NDMA exposure and NDMA frequency.  The Court’s ruling is merely that, as pled, the Court cannot conclude that the Plaintiffs have plausibly alleged a substantial increase in the risk of cancer.

Id. at *17.

On top of all this, plaintiffs’ allegations as to the current existence of a “diagnostic testing regime” that supposedly would help the plaintiff class get early cancer detection screenings was not plausibly factually alleged and thus got TwIqballed.  “The Plaintiffs’ allegation amounts to a ‘naked assertion devoid of further factual enhancement.’”  Id. (quoting Iqbal itself).  “[T]he Plaintiffs’ allegations are merely a recitation of the required elements.”  Id. at *18.

One wonders what plaintiffs did plead in all of these 2,000+ pages, since it certainly wasn’t the necessary elements of medical monitoring.

Beyond medical monitoring, plaintiffs re-raised their failure-to-report allegations involving the FDA, which the court had already indicated were preempted in an opinion we discussed previously.  We are reminded of a quote attributed (probably falsely) to Einstein:  “The definition of insanity is doing the same thing over and over again and expecting different results.”

In the Court’s Order Granting in Part and Denying in Part the Branded Defendants’ Rule 12 Partial Motion to Dismiss Plaintiffs’ Three Master Complaints as Preempted by Federal Law, the Court concluded that the Plaintiffs’ claims for failure to warn consumers through the FDA are pre-empted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), for the reasons that the Eleventh Circuit Court of Appeals outlined in Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017).  The Court dismisses the claims with prejudice for that reason.  In light of this ruling, the Court need not address arguments directed to the viability of the claims under state law and pleading deficiencies.

Zantac, 2021 WL 2682659, at *21.

As to the economic loss claims, plaintiffs were held to have Article III standing by reason of claimed economic injury.  Id. at *25-28.  Bexis, being a veteran of the Engle wars, has generally mixed feelings about standing arguments of this sort, because success in denying constitutional standing in federal court has led plaintiffs in some cases to try again in state court, without the defendant having any way to remove (there being no standing) to federal court.

Significantly, the court required plaintiffs asserting claims concerning prescription (as opposed to OTC) products to plead facts satisfying the elements of the learned intermediary rule.  That should be fatal to any class action, since learned intermediary rule issues are inherently individualized.

The Defendants argue that the Plaintiffs’ failure-to-warn claims concerning prescription [products] fail as a matter of law under the learned intermediary doctrine. This is so because Plaintiffs do not allege that their physicians were inadequately warned about the alleged cancer risk associated with [the drug], or that their physicians would have made different prescribing decisions if they had been warned.

Id. at *28 (citations and quotation marks omitted).  Once again, the plaintiffs’ already massive complaint was inadequate.

[T]he Court dismisses the Plaintiffs’ prescription-based claims [some 700 separate counts] without prejudice, and with leave to plead allegations that are specifically relevant to the learned intermediary doctrine.  This scope of leave is not broad, but rather extremely narrow and specific as to this discrete issue.

Id.

Finally, the court clears the way for the defendants to challenge other aspects of the plaintiffs’ economic loss complaint, specifically the applicability of “safe harbor provisions” in the consumer protection statutes of 24 states, and “[r]elatedly, [that] the Plaintiffs’ consumer protection, implied warranty, and unjust enrichment claims are barred, since the Defendants’ FDA-approved labels were presumptively lawful and not false or misleading.”  Id. at *29.  Also defendants may challenge plaintiffs’ unjust enrichment claims on the next go-round on various state-law grounds.  Id.

Defendants will have to “seek leave of Court” to do this at some “later stage of the litigation,” id., and we wonder if it will ever be necessary.  That’s because we’re not at all sure how many “later stages” of litigation there will be.  As discussed, the biggest takeaway from this edition of the Zantac chronicles is the evident scientific bankruptcy of the plaintiffs’ risk and causation positions.

The Drug and Device Law Rock Climber celebrated her birthday this week by acquiring a companion for the Irascible Rescue Pomeranian (you can read about him here). The new family member is a four-month-old Australian Shepherd mix, pure white with blue eyes.  We sense figurative ears perking up at this description, as dog- (and cat-) savvy readers are no doubt aware that this lack of pigmentation is genetically linked to deafness.  And, indeed, the puppy is totally deaf, “thrown in” as an extra when a previous owner purchased another puppy (not deaf) from his litter, then dumped because he was “too much trouble.”  Puppies born deaf have no idea that anything is “missing.”  Taught to understand sign language early, they lead full lives (this is a wonderful book about a deaf Great Dane) and they are exceptionally loving and rewarding for the right owners.  We can’t wait to meet our new “grand-dog” and to watch him blossom.

Deafness does not figure in today’s case (shocking, we know, that there is no logical transition), except to the extent that the plaintiffs turned a deaf ear to well-established preemption jurisprudence.  In Jankowski v. Zydus Pharmaceuticals USA, Inc., 2021 WL 2190913 (D.N.J. May 28, 2021), the defendants manufactured Amiodarone, the generic form of a last-resort drug used to treat ventricular fibrillation and ventricular tachycardia in individuals who were facing probable death and whose conditions did not respond to other available treatments.  The plaintiffs alleged that the manufacturer of the branded version of the drug had “aggressively and successfully” marketed its product for inappropriate off-label use as a first-line therapy,   Jankowski, 2021 WL 2190913 at *1, and that the defendants took advantage of this marketing plan and “directly benefited from the directing marketing of the [branded] drug for off-label uses” through increased sales of their products.

There is nothing we haven’t seen before, and we have already drawn lessons from this litigation.

The plaintiffs alleged that the defendants failed to provide, or make available for distribution, an FDA-required Medication Guide, thereby failing to inform doctors, distributors, and patients of the dangers associated with the drug and of the fact that it was not intended for use as a first-line treatment.  With this “hook,” the plaintiffs asserted a litany of product liability claims:  failure to warn, negligent off-label marketing and sale, negligence per se, manufacturing defect, and fraud.  The defendants moved to dismiss the complaint, arguing federal preemption and failure to state a claim.

The court began by providing background about “impossibility preemption,” which, as many of you are aware, preempts state law claims when it is “impossible for a private party to comply with both state and federal requirements.”  Id. at *2 (citation to Bartlett omitted). The court went on to explain Mensing’s holding that traditional failure-to-warn claims against manufacturers of generic drugs are preempted because only branded manufacturers can unilaterally change drugs’ labels – generic manufacturers’ labels are required to be identical to the labeling of the branded versions of their drugs.  Finally the court set the stage by citing Frei v. Taro Pharm. U.S.A., Inc., 443 F. Supp. 3d 456 (S.D.N.Y. 2020), which followed Buckman to hold that “when a plaintiff’s claims exist solely by virtue of the FDCA’s requirements, state law claims are impliedly preempted.”  Id. at *3 (internal punctuation and citations omitted).  (We have discussed Frei in these pages – here, for example, in our fifty state survey on “failure to report to the FDA” decisions – more about that in a minute – here and here).

Failure to Warn Claims

The plaintiffs asserted failure-to-warn claims sounding in both strict liability and negligence, relying on the defendants’ alleged failure to provide “Medication Guides” to circumvent the preemption of traditional failure-to-warn claims.  As in Frei, as the court explained, the plaintiffs “conflate[d] a failure to provide the Medication guide in sufficient numbers with misbranding of the drug, in an attempt to couch their failure to warn claims in traditional state tort law.”  Id. at *4 (internal punctuation and citation omitted).  And, as in Frei, the court held that the claim was preempted because the plaintiffs did not identify a parallel state law that required distribution of the Medication Guide.

Manufacturing Defect Claim

As we’ve learned already, “all claims that seek to change warnings concerning generic drugs, however, they’re pleaded – read, disguised – by plaintiffs are preempted.”

It was “clear that the existence of the FDA’s Medication Guide regulation [was] the gravamen of” the manufacturing defect claim.  Id.  The plaintiffs alleged that the failure to provide a Medication Guide violated the FDA’s “Good Manufacturing Practice for Finished Pharmaceuticals” regulation, and that failure, along with the failure “to implement a safer alternative design for the delivery of the Medication Guide” (anyone else’s eyes rolling at this nonsense?) rendered the drug “adulterated.”   Underscoring the obvious, the court stated, “First, Plaintiffs’ allegations here do not sound in defective manufacturing and may be dismissed on that basis.”  Id. at *5.

In addition, the court again found that the plaintiffs did not assert a state law claim that paralleled the FDA requirement, because New Jersey’s law addressing adulterated drugs deems a drug “adulterated” when it is used as the labeling suggests, and the Jankowski plaintiffs did not and could not seek to change the label on their drug.   The court concluded, “To the extent Plaintiffs plausibly allege a claim for manufacturing defect, Plaintiffs’ claim is preempted.”

Failure to Report Adverse Events to the FDA

The court explained, that “a manufacturer’s failure to report adverse events to the FDA can form the basis of a parallel claim that survives preemption,” in states that recognize such claims.” (Again, see our 50-state survey for much more on this.)  But New Jersey “is a jurisdiction that declines to recognize a separate state law duty to warn the FDA,” so there was no parallel state-law claim and, again, this claim was preempted.  Id. (citations omitted).   Even the claim were not preempted, as the court explained, the plaintiffs only “speculatively alleged that [the defendant] failed to report adverse events to the FDA” and did not “allege actual adverse events that [the defendant did not report to the FDA,” so the allegations failed to satisfy Twiqbal and the claim failed on that basis as well.

Negligent Marketing and Sale for Off-label Purpose

The plaintiffs claimed that the defendants took advantage of the branded manufacturer’s off-label marketing by “marketing, selling, and distributing [the generic drug] as a first-line therapy . . . without the Medication Guide” and that they failed to correct information appearing in in third-party prescribing reference sources.   Once again, the court held that Mensing “impossibility preemption” doomed the claims, because the plaintiffs alleged that the Medication Guide and third-party reference materials constituted labeling and defendants, as generic manufacturers, were not permitted to make changes to their drugs’ labeling.

Finally, the court dismissed the negligence per se claim, again premised on issues related to the Medication Guide, and the fraud claim, based on the defendants’ alleged failure to report adverse events and to correct misleading information in third-party reference materials, on the same airtight reasoning it had applied throughout the decision.   And so, with eyebrow firmly raised, the court thwarted the plaintiffs’ attempted end-run around federal preemption and dismissed the complaint, albeit without prejudice.  The court provided the plaintiffs “one final opportunity” to amend the complaint, and we’ll keep you posted on that.  In the meantime, stay safe out there.

As we discussed in our recent 50-state survey on failure-to-report claims, plaintiff-side allegations seeking to predicate “warning” liability on a defendant’s allegedly failing to comply with FDCA adverse event reporting claims are “relatively new.”  That’s because, like so many other novel claims we’ve seen lately, it’s a transparent dodge to avoid preemption.  We said there:

In the FDA context, the idea of a “reporting” cause of action for failure to warn is almost never seen outside of situations where a manufacturer’s traditional duty to warn is preempted by federal law.  We can count on our fingers the number of pre-preemption FDCA-based failure-to-report cases, and still have quite a few fingers left over.

In the latest development in the failure-to-report arena, the Second Circuit has certified the question whether Connecticut recognizes such a claim to the Connecticut Supreme Court:

Whether a cause of action exists under the negligence or failure-to-warn provisions of the Connecticut Product Liability Act, or elsewhere in Connecticut law, based on a manufacturer’s alleged failure to report adverse events to a regulator like the FDA following approval of the device, or to comply with a regulator’s post-approval requirements.

Glover v. Bausch & Lomb Inc., ___ F.4th ___, 2021 WL 3042364, at *12 (2d Cir. July 20, 2021) (citation omitted).

The court professed to do so out of an abundance of caution, pointing to Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), as a “cautionary tale.”  2021 WL 3042364, at *9:

The Ninth Circuit’s decision in Stengel is particularly illuminating in that regard. Several years after the Stengel court concluded that “Arizona law contemplate[d] a warning to a third party such as the FDA,” the Supreme Court of Arizona considered the issue and held that Arizona law in fact imposed no such duty to warn the FDA.

Id. (citations and quotation marks omitted).  We addressed this issue in depth in the Arizona entry of our 50-state survey.

The Second Circuit also criticized another of the cases we think (see, Mississippi in our survey) is particularly questionable, Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), for “not includ[ing] extensive discussions of whether the relevant state law provided a cause of action for failure to report adverse events to a regulator.”  2021 WL 3042364, at *8 (observing that Hughes merely “assum[ed] that a failure to warn claim may be pursued under Mississippi law without expressly addressing that issue”) (Hughes quotation omitted).

Since “neither party points to any binding Connecticut authorities on the question of whether manufacturers have a duty to warn a regulator,” id. at *8 Glover certified that question to the Connecticut Supreme Court.

We’re happy to offer our own analysis from our survey, since we believe that the Connecticut Supreme Court has actually dealt with this issue – in the child abuse context – and rejected any common-law failure-to-report claim beyond the scope of a specifically statutorily-authorized claim.

CONNECTICUT

In Ward v. Greene, 839 A.2d 1259 (Conn. 2004), the Connecticut Supreme Court rejected a plaintiff’s attempt to create a tort-based duty “where a mandated reporter fails to report instances of suspected child abuse to designated officials or agencies.”  Id. at 1264.  The court found no merit in the plaintiff’s argument for a failure-to-report duty beyond what the child reporting statute allowed.  Id. at 1267.

[W]e conclude that the [statute] appears to be directed at the child, or children in the case of multiple children placed at risk in a singular incident, who should be the subject of a report of abuse or neglect under the statute and are, accordingly, in need of services.  The policy statement thus suggests that the legislature intended to focus on children who already have been exposed to conduct that amounts to a reportable event, and we do not find merit in the plaintiff’s argument that the statute creates a duty of care to every child who has been in the care of the defendant.

Id. at 1266-67.  Such a claim “depends on the intervening acts of administrative agencies and is, therefore, remote and speculative.”  Id. at 1270.  Therefore, “we cannot say that a mandated reporter owes a legally enforceable duty to children . . . where the benefit would depend entirely on the intervening acts of administrative agencies.”  Id. at 1271.  See also Lundstedt v. Deutsche Bank National Trust Co., 2016 WL 3101999, at *5 (D. Conn. June 2, 2016) (no failure-to-report claim under Bank Secrecy Act).

The same result was reached in Norman v. Bayer Corp., 2016 WL 4007547 (D. Conn. July 26, 2016):

A tort for failure to warn a victim exists under Connecticut law.  But this is a duty to the plaintiff herself, not to some third party, who might then report the danger to the plaintiff.  There is no general or background duty under Connecticut law to report risks to a regulatory body.

Id. at *4 (emphasis original).  Norman recognized the inapplicability of Restatement [(Second) of Torts §388 [1965] to this situation and criticized Stengel for attempting to analogize the two:

[I]t does not follow from this principle [Restatement §388, comment n] that defendants had a state-law duty to warn the FDA, a third party with no relationship to plaintiff.  The analogous party to the shop owner in [comment n] is plaintiff’s doctor − who had a direct relationship with plaintiff and provided the device − not the FDA.  Further, because of the FDA’s independence and bureaucratic process, defendants hardly would have had any “reasonable assurance” that the reported information would have reached plaintiff.  Absent the specific reporting requirements of the FDCA, no Connecticut court would have imposed a duty on defendants to report adverse events to the FDA, rather than alter the warning label or communicate with plaintiff and her doctor.

Id.  Accord Pratt v. Bayer Corp., 2020 WL 5749956, at *8 (D. Conn. Sept. 25, 2020) (“there is no general or background duty under Connecticut law to report risks to a regulatory body”) (quoting and following Norman); Doe v. Bausch & Lomb, 443 F. Supp.3d 259, 273 (D. Conn. 2020) (failure-to-report claim was “wholly derivative of the FDCA”; finding no “duty under Connecticut law that required the Defendants to warn or communicate adverse events to the FDA”) (following Norman); D’Addario v. Johnson & Johnson, 2020 WL 3546750, at *5 (D.N.J. June 30, 2020) (finding “no separate state law duty to warn the FDA”) (citation omitted) (applying Connecticut law); Simoneau v. Stryker Corp., 2014 WL 1289426, at *10 (D. Conn. March 31, 2014) (plaintiff “identifies no separate state law duty to warn the FDA”).  See also [In re Allergan Biocell Textured Breast Implant Products Liability Litigation], 2021 WL 1050910, at *29 [((D.N.J. March 19, 2021)] (following Norman).

We note that Doe v. Bausch & Lomb, 443 F. Supp.3d 259 (D. Conn. 2020), cited above, is the decision that was appealed in Glover, the plaintiffs having evidently abandoned their attempt to proceed pseudonymously.

In addition to failure to report, the Second Circuit certified a second question to the Connecticut Supreme Court, concerning whether the Connecticut product liability statute subsumes claims under Connecticut’s consumer protection statute.  The product liability statute states that it “shall be in lieu of all other claims against product sellers, including actions of negligence, strict liability and warranty, for harm caused by a product.”  Conn. Gen. Stat. Ann. §52-572n(a).  Despite alleging failure to warn and design defect claims, plaintiffs tried to shoehorn their consumer protection claims into an exception for improper promotion of non-defective products for “illegal purposes” recently created in Soto v. Bushmaster Firearms International, LLC, 202 A.3d 262, 295 (Conn. 2019).  For reasons that are less than clear, since every Connecticut case cited in Glover rejects “claim[s] based on an allegedly defective product” from being encompassed by the Soto decision, 2021 WL 3042364, at *10-11, and the claim is probably preempted in any event, id. at *9-10, the Second Circuit also certified that question:

Whether the Connecticut Product Liability Act’s exclusivity provision, bars a claim under the Connecticut Unfair Trade Practices Act, based on allegations that a manufacturer deceptively and aggressively marketed and promoted a product despite knowing that it presented a substantial risk of injury.

Id. at *12 (citations omitted).

Frankly, we don’t see either question as that unsettled to be deserving of certification − given the Connecticut precedent discussed above, and the lack of any caselaw extending Soto, in defiance of a strong exclusivity clause, to products that plaintiffs claim are defective − but since the undermanned panel (one judge died in the interim) decided to punt to the Connecticut Supreme Court, we’ll root for the defense to prevail there.

Today’s case, Bradley v. CVS Pharmacy, Inc., 2021 Cal. App. LEXIS 451, 2021 WL 2176797 (Cal. Ct. App. May 28, 2021), is not about drug or device product liability, but its discussion of deference to administrative agencies is interesting. There are several different but closely related doctrines that either require or permit judicial deference to administrative agencies. One such doctrine, typically described as the exhaustion doctrine, requires parties to exhaust their remedies in an administrative tribunal before seeking relief in court. We know this doctrine fairly well because it keeps getting used against us in our pro bono prisoner civil rights cases. Whenever we represent a prisoner alleging some sort of deprivation by prison authorities (e.g., housing or diet restrictions, access to certain written materials, discipline, etc.), the first defense raised by the other side is failure to exhaust administrative remedies. Sometimes they have a point. Sometimes they don’t.

In Bradley, the plaintiff was a doctor who specialized in the treatment of pain. A pharmacy stopped filling prescriptions written by that doctor because it spotted what it believed was a pattern of overprescribing controlled substances. (You might recognize this fact pattern to be something of a hot button issue these days. Your law firm might even be involved in some way in opioid litigation.) The doctor sued the pharmacy, seeking a preliminary injunction requiring it to fill the prescriptions. The trial court denied the injunction, ruling that the doctor should first have exhausted administrative remedies with the California State Board of Pharmacy. The appellate court affirmed, but on alternative grounds. How it got to those alternative grounds makes for good reading on the various species of exhaustion/deference/abstention doctrines.

The appellate court concluded that the exhaustion doctrine did not apply here.There are three rationales supporting exhaustion in certain situations. First, an aggrieved party is generally required to seek administrative relief when a statute and lawful regulations pursuant thereto establish a quasi-judicial administrative tribunal to adjudicate statutory remedies. In such a situation, the administrative tribunal is charged with the responsibility to resolve the dispute, and the courts may act only to review the final administrative determination. Second, the exhaustion doctrine generally applies when a private or public organization has provided an internal remedy. This strand of the doctrine is based on a judicial policy that the association itself should in the first instance pass on the merits of an individual’s application rather than shift this burden to the courts. Third, courts have required exhaustion of administrative remedies in a variety of public contexts where the administrative agency possesses a specialized and specific body of expertise in a field that particularly equips it to handle the issue in dispute.

The Bradley court held that the first two rationales for administrative exhaustion did not apply. The State Board of Pharmacy certainly had enforcement powers, but it had no power to adjudicate civil lawsuits. The doctor’s claims, whatever their merit, were originally cognizable in court. Moreover, there was no private or public organization that provided an internal remedy. The State Board “is not an organization with an internal dispute resolution procedure, but an oversight and enforcement entity.”

All that being said, there was no doubt that the State Board of Pharmacy possessed peculiar expertise. It was also well-positioned to “adopt a uniform approach” to evaluating whether pharmacy programs prescription surveillance programs were consistent with pharmacists’ professional obligations. What then? Is one out of three good enough? Nope.

But that brings us to another doctrine: primary jurisdiction. The primary jurisdiction doctrine permits judicial deference to administrative expertise. Like the exhaustion doctrine, the doctrine of primary jurisdiction promotes comity between courts and agencies. The major difference between the two doctrines is whether courts are required to defer to an administrative agency. The exhaustion doctrine applies where a claim is cognizable in the first instance by an administrative agency alone, and the primary jurisdiction doctrine applies where a claim is originally cognizable in the courts but involves issues which, under a regulatory scheme, have been placed within the special competence of an administrative body. In the latter circumstance, the judicial process is suspended pending referral of such issues to the administrative body.

In Bradley, the court held that primary jurisdiction supported a stay of the doctor’s civil suit against the pharmacy pending a determination by the State Board of Pharmacy as to whether the pharmacy properly opted not to fill the prescriptions. The doctor complained that a referral to the Board would cause him detriment from delay, but the appellate court essentially said that was too bad and that, in any event, the doctor could have avoided such delay by going immediately to the Board. Whatever the Board decided, the doctor would eventually get his day in court, but it would be a court that had the benefit of the Board’s expertise.

Though the trial court had erred in invoking exhaustion rather than primary jurisdiction, the record showed that the trial court considered the relevant factors for primary jurisdiction and exercised its discretion in a manner that fully supported primary jurisdiction. Accordingly, the appellate court in Bradley affirmed denial of the primary jurisdiction.

We’ve written about primary jurisdiction before. (Here, for example.) It has been applied in some cases a bit closer to the type that occupy us, though not often enough. We recognize it is now a mere pipe dream, but imagine how much more fair and consistent things would be, and how much judicial efficiency would be improved, if plaintiffs whose product liability claims boiled down to an assertion that the defendant violated FDA regulations, or the product was not as safe and effective as the FDA concluded, or even that FDA got things wrong, were sent, via primary jurisdiction, to get the FDA’s input. We’d wager that the extra effort involved, plus the likely advice of the FDA, would trim back docket-loads, including Multidistrict Litigation megamonsters, substantially. What could serve judicial efficiency better than that?

We’ve used the term one-two punch to refer to a couple different situations – Daubert wins followed by the grant of summary judgment; Mensing preemption for generic manufacturers and no innovator liability for brand manufacturers.  And we’re going to dust it off again today to refer to Couturier v. Bard Peripheral Vascular, Inc., — F.Supp.3d –, 2021 WL 2885903 (E.D. La. Jul. 8, 2021).  Not only did defendant win summary judgment on design defect, but it also defeated plaintiff’s motion for summary judgment on several affirmative defenses.  Another one-two combination victory for defendants.

Five years after implantation, the IVC filter implanted in plaintiff perforated causing some complications.  Id. at *3.  Plaintiff’s suit is governed by Louisiana law which means his exclusive cause of action was the Louisiana Products Liability Act (LPLA).   Under the LPLA, plaintiffs can sue for design defect, failure to warn, manufacturing defect, and express warranty.  Plaintiff brought a claim for each, except manufacturing defect.  After summary judgment, all that remained was a disputed issue on failure to warn.

To prove a design defect claim, the LPLA requires evidence of a feasible alternative design.  However, the alternative design must not only have existed, but have been capable of preventing the plaintiff’s damage.  Id. at *6.  If the alternative did not make the product safer, the defendant could not have prevented the plaintiff’s injuries and cannot be liable for design defect.  First, as defendant points out, plaintiff’s own experts concede that all IVC filters can fracture and perforate.  Id.  These are known and warned about risks of the device and therefore cannot be design defects.  While plaintiff argued the filter has “design deficiencies,” he failed to describe the deficiencies or how they caused the perforation.  Id. at *7.  Plaintiff next argued that defendant failed to follow industry standards in the design process.  But “[p]laintiff confuses design process with a product defect and does not make a causal link that some misstep in not adhering to these standards lead to a defect in the filters.”  Id.  Finally, as to the alleged alternative design, plaintiff’s experts only opined that defendant’s filter had higher complication rates.  But that “does not negate the fact that these alternative filters sill put patients at risk of the same injuries as the [defendant’s] filter.”  Id.  Without evidence that an alternative design could have prevented his injuries, defendant was entitled to summary judgment on design defect.

The court did not award summary judgment on failure to warn based on the prescriber’s testimony that if he had been provided information about the allegedly higher risks, he would have gotten a different filter to use.  Id. at *8.   But the prescriber’s testimony was instrumental in the dismissal of plaintiff’s express warranty claim.  Plaintiff could not demonstrate that any statement by defendant was relied on by plaintiff or the surgeon in choosing defendant’s filter.  Instead, the prescriber testified that the specific filter was the only one available at the hospital.  Id. at *9.

On the flip side, plaintiff moved for summary judgment on six of defendant’s affirmative defenses and lost across the board.

Failure to mitigate and Comparative and/or Contributory Negligence:  Plaintiff failed to seek treatment for five years after the IVC filter was implanted and ignored his doctor’s advice after the perforation was identified.

Assumption of the risk:  Plaintiff’s wife signed an informed consent acknowledging plaintiff’s surgeon advised him of all known risks and plaintiff accepted those risks by undergoing the surgery.  Further, plaintiff’s failure to see medical treatment prevented discovery and treatment of his alleged injuries.

Sole proximate cause and superseding/intervening cause:  Defendant is entitled to introduce evidence of any potential or alternative/intervening causes.  In this case that includes expert evidence of physician malpractice in placement of the device.

Comparative fault of non-parties:  This too was supported by the evidence of physician malpractice and the surgeon’s testimony that he did not follow the IFU in several material ways.

Id. at *9-11.  Sounds like a lot of excellent evidence to us.

This one-two punch may not have been a complete knockout, but in an upcoming post we’ll tell you about punch number three – some fantastic in limine rulings.

Thanks to Lori Cohen at Greenberg Traurig for bringing this great defense win to our attention.

 

With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”

That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the “F.4th”).  The FDA made a back-door move to prohibit an off-label use it didn’t think was safe using what it claimed was its power to “ban” a device under 21 U.S.C. §360f.  Not so fast, held the District of Columbia Circuit.  To do so would run afoul of another portion of the FDCA, 21 U.S.C. §396, which forbids the FDA from interfering with the practice of medicine.

The medical devices in question were electroshock therapy machines.  We don’t claim to know anything about electroshock therapy, and it seems like a blunt instrument from the days of unanesthetized amputations and leeches, but according to the American Psychiatric Association, it is “highly effective for the relief of major depression.”  So we’re not going to comment any further on the medicine.  The FDA came to the conclusion that, for a different group of patients, those suffering from “self-injurious or aggressive behavior,” use of these medical devices was not sufficiently effective to overcome the risks of the procedure.  81 Fed. Reg. 24,386 (FDA April 25, 2016).  We use “procedure” advisedly, since the FDA thus purported to ban, not the devices, but their use for this particular form of treatment.

On a “petition for review,” the plaintiffs − who were persons who performed and/or wished to receive the banned treatment – skipped the district court altogether and challenged the FDA’s action directly in the District of Columbia Circuit.  2021 WL 2799891, at *2.

The FDCA gives the FDA the power to “ban” medical devices (and also drugs):

Whenever the [FDA] finds, on the basis of all available data and information, that − (1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury . . . [it] may initiate a proceeding to promulgate a regulation to make such device a banned device.

21 U.S.C. §360f(a)  (omitting irrelevant subpart b).  However, in 1997, Congress specifically deprived the FDA of the power to regulate the practice of medicine by prohibiting off-label uses of medical devices:

Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.

21 U.S.C. §396.  Congress continued the power of the FDA to contraindicate uses in its review processes, but not the power to prohibit doctors from exercising their independent medical judgment to treat their patients:

This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations.

Id.

Section 396 thus “ensures that once the FDA permits a device to be marketed for one use, health care practitioners have the flexibility to draw on their expertise to prescribe or administer the device for any condition or disease, not just the use the FDA approved − in short, to practice medicine.”  2021 WL 2799891, at *3 (citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001)).  Thus §396 “protects the liberty of doctors and patients to use approved devices in any manner they wish.  Id. (citing Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1344 (10th Cir. 2015)).  We’ve commented many times about the FDA’s inability to regulate the practice of medicine.

Given the express limits imposed by §396, the FDA’s “greater” power to ban a medical device altogether under §36f did not include the “lesser” power to ban that same device for a particular disfavored medical use.

[W]e are not persuaded that because the FDA possesses the “greater” power to completely ban a medical device, it must have the “lesser” power to tailor a ban to only certain uses.  Courts regularly recognize that a greater power does not imply the existence of a lesser power, especially when the exercise of that claimed lesser power uniquely offends some external constraint. . . .  The problem is that once the FDA approves a device and then tries to ban it for specific uses, it defies the limitation that [§]396 imposes. Just as in other contexts, [§]396 operates as an external constraint − preserving the ability of physicians to make professional judgments about off-label uses − that prevents the FDA from exercising a lesser power merely because it possesses a greater one.

Rotenberg, 2021 WL 2799891, at *5 (citations omitted).  The FDA’s bootstrap argument, that its purported “ban” meant that the devices in question was no longer “legally marketed” for that use under §396, was thus “unpersuasive.”  Id. at *4.   “[T]hat construction would allow the FDA to escape the constraints of [§]396 whenever it bans a device,” which directly affronts that section’s provision that “nothing in this chapter” gives the FDA power to interfere with medical practice.  Id. at *5.

Furthermore, the FDA’s backdoor attempt to restrict medical practice runs afoul of federalism concerns.  Rotenberg recognized the same point Bexis made in his recent off-label use law review article:  “off-label medical practice is not regulated at the federal level” and “[t]he right to practice medicine is subject to the paramount police power of the state.”  James Beck, “Off-Label Use in the Twenty-First Century: Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1, 10 (2021) (quotation marks and footnotes omitted).

[W]e require an explicit authorization from Congress before we will permit an agency to regulate in an area that alters the balance of powers between states and the federal government. . . .  States, not the federal government, traditionally have regulated the practice of medicine.  Choosing what treatments are or are not appropriate for a particular condition is at the heart of the practice of medicine. . . .  The FDA has no authority to choose what medical devices a practitioner should prescribe or administer or for which conditions.

Rotenberg, 2021 WL 2799891, at *6 (citations omitted).

You might ask, what about judicial deference to the FDA’s interpretation of its own organic statute?  Apparently, the FDA never argued so-called “Chevron deference” in the Rotenberg case.  Id. at *3 (‘the FDA did not invoke Chevron deference or even cite the case in its briefing”).  That didn’t stop the dissenting judge from going there, id. at *9 (Srinivasan, C.J., dissent), but that raises an interesting conundrum for the FDA going forward.

Does the FDA want Rotenberg to be the case – and off-label use the subject – that potentially topples the entire agency deference edifice?  We note Rotenberg’s citation to the Caplinger case.  As we’ve pointed out before, Caplinger was written by Justice Gorsuch, who just so happens to be the Supreme Court’s primary proponent of reconsidering Chevron, U.S.A., Inc. v. National Resources Defense Council, Inc., 467 U.S. 837 (1984), in particular, and agency deference in general.  Particularly given what Congress had to say in §396, Rotenberg would not seem to be fertile ground for an administrative agency’s claim of Chevron deference.

Stay tuned.