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Of late, the Fifth Circuit has come in for some criticism over rulings involving science, the FDA, and medicines.  But apparently even it has its limits—and Article III standing is one.

In Children’s Health Defense v. FDA, No. 23-50167, 2024 U.S. App. LEXIS 1528, 2024 WL 244938 (5th Cir. 1/23/24), a non-profit and several parents challenged the FDA’s emergency use authorization (EUA) that permits the administration of COVID-19 vaccines to children.  In essence, the plaintiffs sought to have the FDA’s regulatory decision overturned on the ground that the Agency failed to follow the Administrative Procedures Act, and to enjoin the FDA from “marketing or promoting” COVID-19 vaccines.

So what was the alleged harm in Children’s Health Defense that might allow these plaintiffs to overturn an FDA regulatory decision?  How had the FDA’s issuance of an EUA during the COVID-19 pandemic caused a legally cognizable injury to these plaintiffs?

According to the plaintiffs, their injury was that they feared “a third party may vaccinate their children without their consent, that a third party might harass their children for being unvaccinated, and that their children may be exposed to pro-vaccine messaging,” such as a Sesame Street segment about Elmo getting vaccinated.     

You might be thinking that these alleged injuries sound pretty speculative, as well as attenuated from the FDA activity of issuing a COVID-19 vaccine EUA, and you would be right. 

In legal terms, the issue was whether these plaintiffs have standing, something required by Article III of the U.S. Constitution:

[T]o establish standing, a plaintiff must show (i) that he suffered an injury in fact that is concrete, particularized, and actual or imminent; (ii) that the injury was likely caused by the defendant; and (iii) that the injury would likely be redressed by judicial relief.

Children’s Health Defense, 2024 WL 244938 at *2.

As the Fifth Circuit acknowledged, speculation “that some hypothetical third party might, at some hypothetical point in the future and through some hypothetical means, [ ] vaccinate their children against their wishes” was neither a concrete nor an imminent alleged injury.  As to the exposure to a viewpoint with which the plaintiffs disagreed, the Fifth Circuit recognized it is not an injury in fact to allege a “psychological consequence produced by observation of conduct with which one disagrees.”  Id. at *4 (internal citation and quotes omitted).

In addition, the connection to the FDA was missing:  “Even if the alleged harms were plausible,” each would be “the result of a third-party action, not the FDA.”   In other words, even if there was an imminent risk that someone might help one of the plaintiff’s children obtain the vaccine against the parent’s wishes, the solution would be to seek an injunction against that person—it is not to try to upend the FDA regulatory decision authorizing the vaccine in the first place.

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Since honoring the Ninth Circuit’s decision in Nexus Pharms., Inc. v. Cent. Admixture Pharm. Servs., Inc., 48 F.4th 1040 (9th Cir. 2022), as being our third best decision of 2022, we have been waiting for (and expecting) a court to apply it to a food labeling case.  And now one has – Collyer v. Catalina Snacks Inc., 2024 U.S. Dist. LEXIS 9637 (N.D. Cal. Jan. 18, 2024). 

Plaintiff’s fraud claims in Collyer allege that the packaging of four keto-friendly cereals was misleading because the cereals do not contain an ingredient pictured on the package.  For example, the package for the Banana Chocolate cereal has real bananas pictured, but the banana taste comes from “natural flavors.”  Similarly, while the Apple Cider Donut cereal depicts both an apple and a donut, the product itself contains neither apple or cider with the “taste” again coming from natural flavors.  Id. at *2-3.

Before we get to the application of Nexus, the discussion of Collyer would be incomplete without acknowledging that these claims also failed the “reasonable consumer” standard under California’s Unfair Competition Law (UCL), False Advertising Law (FAL), and the Consumer Legal Remedies Act (CLRA).  The standard is whether a “reasonable consumer” would be misled by the product’s representations.  While this is typically a question of fact, in “rare situations” a court can determine that the alleged violations of UCL, FAL, and CLRA “are simply not plausible.”  Id. at *9.  This is such a situation.  First, plaintiff admitted that she did not believe the cereals contained whole bananas or apples.  Second, next to the images of apples, bananas, and donuts were the words “serving suggestion.”  Reasonable consumers understand that they are not getting whole fresh fruit in their box of cereal.  Third, no where on the packaging is there any misrepresentation of the ingredients or any assertion that the products are “made with” the “characterizing flavors.”  Finally, the court could not overlook that the cereals are described as “keto-friendly” and contain “0g sugar.”  A reasonable consumer, especially one shopping for a specialty product, would understand that the cereals do not contain apples, bananas or cider – all of which contain sugar.  Id. at *10-13.  Plaintiff is getting a chance to replead these claims to see if she can satisfy her pleading obligations, but given the heightened pleading standard for fraud claims, we are dubious.

That brings us to Nexus and preemption.  Plaintiff brought her UCL claim under all three of its prongs – that the labeling was unfair, fraudulent, and unlawful.  The unlawful claim is based on alleged violations of the Food, Drug, and Cosmetic Act (FDCA) as incorporated in California’s Sherman Law.  Id. at *14.  But claims based on violations of the FDCA are preempted by Buckman Co. v. Plaintiffs’ Legal Comm, 531 U.S. 341 (2001).  So, traditionally plaintiffs try to flip the equation.  They allege that their claims are for violations of the Sherman Law which incorporates the FDCA and therefore, they are bringing parallel state law claims.  That’s where Nexus comes in.  The Ninth Circuit held that false advertising claims that “would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA had not itself concluded there was a violation” are preempted.  Id. at *16 (citing Nexus, 48 F.4th at 1048). Collyer also throws in a little language from Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228, 1235 (9th Cir. 2013) (state law claims preempted where they are dependent on a violation of federal law).  Therefore, plaintiff’s claims based on the unlawful prong of the UCL are dismissed with prejudice.

We have been anticipating this expansion into food-related litigation since Nexus was decided.  California is a hotbed of food-related litigation thanks in most part to the Farm Fresh Salmon decision by the California Supreme Court which is essentially the antithesis of Nexus.   Nexus is not controlling in state court, but we are hopeful it can be used to cut back on the plethora of bogus food class actions in California federal court. Collyer may be the first, but we doubt it will be the last.

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Law school exams are usually exercises in issue spotting. Buried within the fact scenarios are various legal issues. The student earns points by identifying those issues and discussing how they should be resolved.  Sequence also matters.  It makes sense to walk through threshold issues, such as jurisdiction, first. 

Goins v. Saint Elizabeth Medical Center, Inc., 2024 U.S. App. LEXIS 1547 (6th Cir. Jan. 22, 2024), would be a swell issue spotter on a law school exam. It is an interesting, albeit unpublished, Sixth Circuit case regarding PREP Act preemption. It also presents questions of lower court and appellate jurisdiction. 

And it all arrives in the form of a medical malpractice case. The plaintiff had received her second dose of Moderna Covid-19 vaccine. A couple of days later, she was admitted to a hospital emergency room because of unusual swings in her blood sugar that “flummoxed” the doctors. One of the doctors used a needle to take a biopsy sample from the plaintiff’s pancreas. 

And now we will pause for a brief interlude that explains why the PREP Act was arguably at issue.  According to the plaintiff, some of her doctors (but not the one performing the biopsy) stated that her symptoms could have been a reaction to the Covid-19 vaccine. 

Got that?

After the biopsy, the plaintiff began to experience severe abdominal pain. This pain appeared to result from the biopsy.  It is possible that her spleen was nicked during the biopsy. The plaintiff had a tough time of it, undergoing a lengthy recovery.  Then she sued Moderna, the pharmacy administering the vaccine, the doctor who performed the biopsy, and the doctor’s medical practice. The complaint included causes of action for negligence, battery, and negligent hiring  

The plaintiff filed the complaint in Kentucky state court.  But Moderna successfully removed the case to federal court under 28 U.S.C. section 1442(a) because Moderna had been acting under the direction of a federal officer. Then the defendants moved to dismiss the complaint because the defendants were immune from suit under the PREP Act. As we have discussed several times before in this blog, the PREP Act provides that a “covered person” shall be immune from liability with respect to all claims involving the use of a “covered countermeasure.”  Manufacturing and administering a Covid-19 vaccine is the most obvious “countermeasure,” so dismissal of the claims against Moderna and the pharmacy was a foregone conclusion. Adios.

But what about the claims against the doctor and his practice for the allegedly negligent biopsy?  After dismissing the claim against Moderna (the party who initially created federal jurisdiction) and the pharmacy, what was left against the doctor and medical practice was “an ordinary malpractice suit brought under Kentucky law, by a Kentucky plaintiff, against Kentucky defendants.”  For that reason, the district court exercised its discretion under 28 U.S.C. section 1367(c) to remand the case to state court. But it stayed the remand to permit the doctor and medical practice to appeal the denial of their motion to dismiss. 

Did the Sixth Circuit have appellate jurisdiction?  Usually the denial of a motion to dismiss is not appealable. It is not a final order. The typical route is to proceed  with the case and then re-raise any issues after a final judgment.  But there is an exception for certain collateral orders. Still, should the case ever have been in federal court?

The answer to that preliminary question is Yes. The Sixth Circuit held that the case was properly removed to federal court on the basis of federal officer jurisdiction because the vaccine manufacturer participated in Operation Warp Speed. That program involved the type of coordination with the government necessary to treat the manufacturer as functionally acting under a federal officer.  At each step of the way, the manufacturer worked under the “direction and control” of the federal government so that its vaccine would be available quickly. 

So far so good. 

Next, the court addressed appellate jurisdiction under the collateral order doctrine. That doctrine permits appeal of a non-final order if that order (1) is conclusive, (2) on an “important” issue separate from the merits of the action, and (3) is effectively unreviewable on appeal from a final judgment.  Sixth Circuit law is clear that a private entity may immediately appeal an order denying an affirmative defense of statutory immunity when the statute provides immunity from suit, as opposed to immunity simply from liability. Immediate review of a decision denying immunity from suit helps “to make good on the deal between the government and the immunized entity, because the core point of immunity is its possessor’s entitlement not to have to answer for his conduct in a civil damages action.”  Accordingly, the appeal by the doctor and his medical practice could go forward. 

That’s where the good news for the doctor and medical practice defendants ends. The Sixth Circuit affirmed the district court’s denial of the motion to dismiss because the allegations of the complaint did not clearly tie the claimed medical malpractice to any vaccine-related medical care. The question was whether it was “definitively ascertainable” from the allegations of the complaint that the biopsy addressed a vaccine side effect.  Reference to vague speculation by other doctors that the blood sugar swings might have been caused by the vaccine was simply not enough. There must be some plausible factual allegation that the Covid-19 vaccine caused the plaintiff’s symptoms before medical treatment comes within the preemptive ambit  of the PREP Act. Notably, the complaint did not allege that the doctor-defendant even knew the plaintiff had received the Covid-19 vaccine. Thus, the complaint did not allege a “covered countermeasure” that would require dismissal under the PREP Act. 

If jurisdiction comes first in the analysis, policy usually comes last. In Goins, the court  rejected the defendant’s argument for PREP Act immunity anytime medical treatment addressed symptoms that had not been ruled out as vaccine sequelae.  The court observed that “[w]hen more than eighty percent of the country has received at least one dose of the Covid-19 vaccine, such a rule would too easily allow the dismissal of valid medical malpractice actions without any plausible factual allegation that the Covid-19 vaccine caused the underlying symptoms. “

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We’ve never seen a case quite like Michaels v. Genzyme Corp., 2023 WL 8828003 (S.D. Ill. Dec. 21, 2023), before, and we hope we don’t again.  Michaels took the “proximate” out of proximate cause.

Here’s why we say that.  Michaels was filed in 2023 over “a paternity test that was conducted in 1989.”  Id. at *1.  That’s right – the alleged product use was 34 years before the suit was filed.  It came back negative for paternity.  That allegedly caused the  parents (both of whom are plaintiffs) to divorce, and plaintiff-mother then remarried, to the person “judicially determined” to be the father of the plaintiff-child.  Id.  So three plaintiffs, the divorced mother and father, and the child tested for paternity

Thirty-one years later, the plaintiff daughter allegedly had a DNA retest (presumably with a modern, much more scientifically advanced test), and claims “test results showed a 99.9999997% probability” of paternity, which was then purportedly confirmed by a second DNA test.  Id. at *2.  So the Michael plaintiffs, exercising 20-20 hindsight, sued the original 1989 test manufacturer for basically every bad thing that had happened to them over the past 30 years.

After a couple of minor speed bumps (res ipsa loquitur and fraud, id., at *2-3), Michaels gets to the main events.  First, the statute of limitations.  While it was undisputed that the relevant statute of limitations was two years, and that the DNA test at issue “occurred more than 34 years ago,” plaintiff skated (for now) on the statute of limitations.  “A plaintiff need not anticipate and attempt to plead around affirmative defenses, including those pertaining to the statute of limitations.”  Id. at 3 (citation and quotation marks omitted).  So Michaels OKed, for now, a 34-years-stale lawsuit.

Even more bizarre was the ruling on proximate cause, which “is an essential element of any negligence action.”  Id. at *4 (citation and quotation marks omitted).  Plaintiffs claimed that the defendant is liable for the decades old criminal conduct of a third-party.  The erroneous DNA test, supposedly caused the plaintiff-parents’ divorce, followed by the plaintiff-mother marrying the man she thought was the plaintiff-daughter’s father, followed by plaintiff daught being “abused by her putative father . . . who has since [2014] been incarcerated.”  Id. at *3.  That’s a breath-takingly attenuated chain of causation if we’ve ever seen one.  The alleged abuser had been “judicially determined” to be the genetic father (what about his DNA test?).  Id. at *1.  The abuser himself was criminally convicted and is in prison, and has no relationship – “special” or otherwise – with the manufacturer defendant.  So, in addition to the extreme passage of time, there are these two, independent superseding causes – a court order and third-party criminal activity.

Beyond that, in Michaels there is the alleged “negligence,” which appears to be nothing more than that the defendant’s test returned a false negative.  No genetic test – not now, and certainly not back in 1989, is 100% accurate, and those kind of risks tend to be the subjects of warnings, in addition to being commonly known.  Michaels is a negligence action, and the plaintiff parents will face comparative negligence issues for deciding to divorce, based on one paternity test, with no confirmation by any similar test administered to the other candidate for fatherhood.  If there were such a second test in 1989 (which we can’t say for sure), then it had to fail as well, given the complaint’s allegations.  So why is one failure actionable, but the other not?

Michaels is a far-fetched lawsuit that we think should not have gotten to first base.  It’s an example of but-for causation run mad.  It certainly should not get to second base.  DNA test manufacturers cannot be made insurers of every possible consequence of a false negative (or false positive) no matter how many years later that consequence may have occurred.

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We don’t see many cases involving human tissue, but medical products derived from human tissue are actually quite common.  Skin replacement products, tissue-engineered cartilage, compounds for treating bone fractures and tumors.  Those kinds of things.  Just yesterday in our annual Ten Best/Ten Worst Cases webinar we discussed a case involving transplanted human eye tissue.  Medical products based on human tissue have been around for a long time, and they are regulated by the FDA

We should not, however, throw around the word “product” too freely because it begs the question of whether human tissue is, in fact, a “product.”  The answer is not always, and not under Illinois law on strict liability and warranty.  That is the holding of Zydek v. Aziyo Biologics, Inc., No. 23-C-3016, 2024 WL 197264 (N.D. Ill. Jan. 18, 2024), which applied the Illinois statute governing blood and organ transactions to dismiss strict liability and warranty claims.

In Zydek, the plaintiff was treated with the defendants’ surgical bone repair product, which was made from human tissue.  To make the product, the defendants acquired cadaver tissue from donor services.  Unfortunately, the defendants received reports that multiple patients who received product made from a particular donor lot came down with tuberculosis, which led to a voluntary recall.  The plaintiff tested positive one month later.  Id. at *1.

The plaintiff sued for negligence, strict products liability, and breach of various warranties.  It turns out, however, that the Illinois Blood and Organ Transaction Liability Act expressly bars strict liability and warranty claims for “entities generally engaged in rendering services for blood- and human-tissue related surgeries.”  Id. at *2.  The plaintiff shrewdly pointed out that the Illinois statute applied only to “services” or “service providers,” whereas the FDA and NIH have labeled the Defendant’s tissue-based bone repair compound as a “product.” 

That, however, was irrelevant.  This is a matter of state-law liability, and the Illinois legislature clearly shields “every person, firm, or corporation” that participates in developing “blood products, blood derivatives and products, corneas, bones, or organs or other human tissue for the purpose of injecting, transfusing or transplanting any of them in the human body.”  Id. (citing 745 Ill. Comp. Stat. § 40/2-3).  Moreover, the Illinois Supreme Court had previously made clear that the Illinois legislature did not incorporate the FDA or NIH definitions of “products.”  Zydek, at *2 (citing Brandt v. Boston Scientific Corp., 204 Ill. 2d 640, 653 (2003)).  As the Illinois Supreme Court held in connection with a tissue-based sling, use of the defendants’ product was incidental to the plaintiff’s surgery.  “Hence, the surgical purpose of the Sling transformed what might ordinarily be considered a product into a legal service under the Act.”  Zydek, at *2.  The same analysis applied here.  The defendants developed the product from human tissue, and its use was incidental to the plaintiff’s surgery.  As a result, the product was “characteristically a service under the Act.”  Id.  The court dismissed the strict liability and warranty claims, leaving only negligence.  Defendants received all the relief they requested, and that seems like the outcome that the Illinois Legislature was aiming for.

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It is a simple fact that product liability plaintiffs almost always prefer state court and product liability defendants almost always prefer federal court.  This is a major reason why removal fights, sometimes intertwined with personal jurisdiction fights, happen so often in these types of cases.  Another reason is that product liability plaintiff lawyers like to sue peripheral defendants along with obvious defendants, looking for deep pockets, dissension in the ranks, nuisance settlements, and non-diverse defendants.  Our “pages” contain many posts relating to the legal theories asserted against these peripheral defendants and whether they have been fraudulently joined to defeat federal court diversity jurisdiction.  Other realities are that California has some of the most pro-plaintiff, pro-product liability laws around and that federal courts in California are very tough on removal.  So, it is not surprising that we see a decision on a somewhat unusual species of removal coming from a California state court in a case where the peripheral, non-diverse defendants were, at most, mere sellers of the product.

In Rubalcava v. Medline Indus., Inc., No. 23-cv-01060-AJB-DDL, 2023 WL 9010545 (S.D. Cal. Nov. 15, 2023), a California plaintiff alleged that the medical walker he purchased broke, causing him to fall and sustain injury.  He sued the Illinois manufacturer of the medical walker in California state court, asserting negligence and strict product liability claims.  Simple removal for diversity (and an eventual challenge to personal jurisdiction), right?  No, the plaintiff also sued a series of entities (we will call them all “UHC entities”) that were involved in providing him insurance and other benefits, at least some of which were from California.  He did so because one of them sold him the walker, presumably at a discount because these same walkers are readily available at major online and brick-and-mortar retailers.  Removal by the manufacturer based on the fraudulent joinder of these entities, right?  No, California law is broad in imposing liability on sellers even if they do not alter the product or its warnings, as long as they are engaged in the business of selling.  (We will set aside why the California law is unfair for “mom and pop” retailers, favors state courts deciding these cases, and arguably would not cover most or all of the UHC entities.)  Instead, the UHC entities removed based on the Federal Officer Removal Statute (“FORS”).  Since the Supreme Court decision in Watson v. Philip Morris Cos., 551 U.S. 142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute.  In Watson, even though it was about FTC regulation, the Court took a shot at the notion that drug and device companies might try to remove their myriad product liability cases based on this statute if interpreted to cover mere regulation.  But the UHC entities included Medicare Advantage Organizations (“MAOs,” not to be confused with monoamine oxidase inhibitors or any particular potentate) regulated by the Centers for Medicare and Medicaid Services (“CMS”) applying various Medicare laws and regulations.

Put simply, among the morass of Medicare are provisions governing Medicare Advantage programs, which companies can elect to provide and eligible people can elect to receive.  Among the benefits that can be provided are the sale of “eligible over-the-counter (“OTC”) items via an online catalog,” which CMS approves.  That is how plaintiff bought his medical walker and why we are talking about federal officer removal.  This is not the same as federal question removal, as defined in Grable & Sons Metal Prods., Inc. v. Darue Eng’g & Mfg., 545 U.S. 308 (2005), which comes up not infrequently in drug and device product liability cases.  In those cases, the question is often whether the claims put FDA compliance at issue or whether the defenses do.  Complaints are routinely written to omit mentions of FDA, the FDCA, and regulatory compliance to avoid both preemption and federal question removal.  Federal officer removal is narrower, although Congress did amend FORS after Watson through the aptly named Removal Clarification Act to, as the Fifth Circuit put it, “broaden[] federal officer removal to actions, not just causally connected, but alternatively connected or associated, with acts under color of federal office.”  In addition, as Rubalcava pointed out, FORS is to be “’liberally construed’ so that federal officials and/or their agents have access to a federal forum in which they may respond to claims that arise out of their official duties.”  Even with these considerations, removal here was a stretch.

Under post-Watson authority in the Ninth Circuit, the key factors in FORS removal are whether “a causal nexus exists between plaintiff’s claims and the actions the defendant took pursuant to a federal officer’s direction” and whether “it has a colorable federal defense to plaintiff’s claims.”  Despite the Removal Clarification Act’s expansion of removal to acts “for or relating to any act under color” of federal office, Ninth Circuit precedent seems to ignore the italicized language and require a “causal nexus.”  The UHC entities offered a number of arguments that involve details of Medicare Part C that we will leave to others.  The bottom line, however, is that the package of benefits that the MAO offers is up to the MAO.  The UHC entities did not have to offer the sale of OTC items and the sale of the particular device, even if on a list that CMS approved, was “an action separate and distinct from the federal duty of providing Medicare benefits or making Medicate coverage determinations.”  That means there can be no causal nexus between the claims for selling an allegedly defective product and the acts taken pursuant to CMS’s direction.  In the Ninth Circuit at least, that means no removal.

In terms of lessons for drug and device companies, we are probably pretty much back where we started.  When sued in California state court with a non-diverse defendant that merely sold a product or otherwise seems to be sued as a mere anchor, the chances for removal, whether by the diverse manufacturer or the non-diverse peripheral defendant, remain low.  That does not mean that various theories of removal should not be considered.  If the allegations against an MAO seller involve the failure to do something that CMS directly forbade, for instance, then even removal by the co-defendant MAO under FORS might have a shot.  Rubalcava did not discuss the specific allegations of why any defendant was purportedly liable, except to say that a wheel on the walker detached, which counsels diving into the actual allegations and judicially noticeable facts when pursuing FORS removal, just as one would with removal based on a federal question or fraudulent joinder.

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We’ve pointed out several times recently (and will be pointing out in an ACI presentation today) that cases against over the counter (OTC) drugs are on the uptick. Why?  Here’s our theory: there are lots of OTC consumers, hence lots of potential plaintiffs, and there are no pesky learned intermediaries, which means that plaintiffs can state fraud theories that are weak, and maybe even a little weird. 

In Singo v. Ricola USA, Inc., 2024 WL 196709 (S.D.N.Y. Jan. 18, 2024), the plaintiff brought a purported class action, alleging that cough drops labeled as containing green tea with echinacea defrauded consumers because the only active ingredient was actually menthol. The plaintiff claimed that the label should have highlighted menthol, not green tea and echinacea, and that consumers were fooled into paying an inflated price. The plaintiff did not allege that the cough drops failed to work, though we are not suggesting that such an allegation would affect the preemption analysis. The plaintiff also did not deny that the cough drops tasted like green tea with echinacea. The complaint included causes of action under the consumer fraud statutes of New York and other states, as well as breach of warranty and violation of the Magnuson Moss Act. 

The defendant moved to dismiss the case because all the claims in the complaint were preempted by 21 U.S.C. section 379r(a) of the Food, Drug, and Cosmetic Act (FDCA), which stops states from imposing any requirement on OTC drugs that “is different from or in addition to, or that is otherwise not identical with” the FDA label.  That motion was granted.  

The Singo court reasoned that preemption is an affirmative defense, so the burden is on the defendant to make out the defense. At the same time, and more importantly, the court correctly held that there was no presumption against express preemption. The Singo court embraced the SCOTUS holding in Puerto Rico v. Franklin California Tax Free Tr., that there is no need for any presumption because the plain language of the statute “contains the best evidence of Congress’ preemptive intent.”  

Then the Singo court got down to business. The court took judicial notice of the full product label. Then it held that the claims were preempted by the FDCA. This case is particularly helpful to defense hacks because the court does not fall for the argument we’ve criticized that anything a plaintiff claims is “misleading” is automatically parallel to the general FDCA “false and misleading” provision.  

The cough drops were generally recognized as safe and effective (GRASE) per an FDA monograph. The plaintiff’s claim that the label misidentifies inactive ingredients as therapeutic goes beyond what the FDA’s monograph requires.  The product undisputedly complies with the monograph’s terms, since it includes the product’s established name and what it does. 

The plaintiff cannot attack a representation allowed by the relevant monograph as misleading.  That would undermine the FDA’s regulatory scheme, which provides specific rules and requirements for the proper labeling of OTC drugs.  As the Singo court observed, “[t]he core of Plaintiff’s claims then is that Defendant’s representations are false and misleading because of the placement of key words on the label.” That means that “any relief the Court would grant Plaintiff would require Defendant to place menthol on the front of the Product’s package.”   By seeking to force the active ingredient from the back to the front of the label, the plaintiff would be imposing an additional, non-identical requirement.  

By dismissing the complaint, the Singo case is music to our ears. It provides soothing relief. That relief is somewhat diminished because the court granted the plaintiff leave to amend.  Nevertheless, we predict that any future iteration of the complaint will continue to — well, do what people do when they have a cough drop in their mouths. 

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Today’s case is a counterpart to our post a few months ago about a case applying Buckman preemption to a contract dispute where adjudicating the alleged breach would have forced the court to decide FDA regulatory issues.  In that case (Thogus Products Co. v. Bleep, LLC, 2023 WL 5607458 (N.D. Ohio 2023)), the question the court would have had to decide was whether a product was manufactured in compliance with the FDA’s Current Good Manufacturing Practices (CGMP) regulations.  We continue to remain neutral in our position on whether Buckman preemption has a place in breach of contract cases but thought it noteworthy to share a recent case that reached the opposite conclusion, albeit not in a drug or device setting–Grand Rivers Enterprises Six Nations, Ltd. v. Knudsen, 2024 WL 149721 (D. Mon. Jan. 12, 2024). 

Plaintiff in Grand Rivers is a tobacco manufacturer.  To sell tobacco in Montana, a manufacturer must be listed on the Montana Tobacco Directory and to do that a manufacturer must receive an annual certification from the state.  Id. at *1.  After several alleged violations, plaintiff entered into a Voluntary Compliance agreement with the State to bring itself into compliance.  That agreement requires plaintiff to “comply with all local, state, and federal laws.”  Id.  Apparently, plaintiff withdrew certain of its tobacco brands from FDA review in 2021 which led the FDA to deem those brands adulterated and prohibited plaintiff from selling them.  Plaintiff however did not remove those products from the Montana Tobacco Directory certifications.  Montana considered this a violation of both state and federal law and therefore a breach of the compliance agreement and grounds to remove plaintiff from the directory.  Id. at *2.   Plaintiff moved for a preliminary injunction.

In trying to establish a likelihood of success on the merits to support the motion, plaintiff argued that Montana’s claim was impliedly preempted as attempted enforcement of the FDCA.  Plaintiff based its argument on 21 U.S.C. § 337(a) and Buckman.  Section 337(a) being the provision that states that all actions to enforce the FDCA “shall be by and in the name of the United States.” And Buckman interpreting that to mean that “it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance” with the statute and its implementing regulations and that private plaintiffs may not assert claims that “exist sole by virtue of the FDCA.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4, 353 (2001).

So, the question in Grands Rivers, as in Thogus previously, was—does § 337(a) bar enforcement of a private contract that requires compliance with the FDCA?  Only in Grand Rivers the court did not believe the action by the Montana Attorney General “[rose] to the level of an attempted enforcement of the FDA” that would be preempted.  The court drew a distinction between a claim based on state tort law and a claim based on breach of contract offering as its reason only that “the Supreme Court has never determined that federal preemption would apply to an alleged breach of the terms of an express voluntary agreement.”  Grand Rivers, at *4.  Likely because the court had other grounds on which to deny the request for an injunction, it opted not to wade into an undecided area of the law.  Notably, Thogus is not cited in the decision.

As we stated in our prior post, we understand how courts can look at contract requirements to comply with the FDCA like negligence per se claims.  Because plaintiff did not comply with the FDCA, its product was deemed adulterated and Montana’s actions based on that non-compliance is actually a claim for violation of the FDCA.  Read that way, it sounds like it should be preempted.  We presume that would have been the decision if the Thogus court had this case.  On the other hand, a contract is a private agreement.   It is not self-evident that § 337(a) bars the enforcement of private agreements.  That’s Grand Rivers.

Again, we come to the same non-conclusion.  Maybe.  Maybe not.  We return the issue to our readers for reaction.

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While putting together our recent Camp Lejeune post on deliberative process privilege, we came across another discovery dispute that we’ve seen in prescription medical product liability mass tort litigation – plaintiffs refusing to produce their social security numbers.  So we decided to take a look at what’s out there.  We found that “Courts have routinely ordered plaintiffs to disclose their social security numbers when that information has some relevance to a claim, or defense, in the litigation.”  Karn v. PTS of America, LLC, 2021 WL 307412, at *5 (D. Md. Jan. 29, 2021).

In In re Camp Lejeune Water Litigation, 2023 WL 8824494 (E.D.N.C. Dec. 21, 2023), plaintiffs in over 1,000 lawsuits refused to supply either their birthdates or social security numbers (“SS#”).  The obvious reason was to prevent defendants from conducting any independent investigation, particularly into the plaintiffs’ medical histories – even though by filing suit they had placed medical history at issue, thereby waiving any privilege.  Camp Lejeune held that both birthdates and SS#s were subject to immediate disclosure under Fed. R. Civ. P. (a)(1)(A)(i), even though not specifically listed, because it was “basic information” necessary to “the ordinary course of investigating each complaint.”  2023 WL 8824494, at *2 (citation and quotation marks omitted).  “[I]t [wa]s undeniably more difficult for Defendant to choose representative diseases and plaintiffs if they cannot obtain records for almost 90% of [the] plaintiffs” that had failed to provide this information voluntarily.  Id. at *3.  All plaintiffs filing a short form complaint were “eligible for discovery” and therefore required to product this information.  Id.

In the class, rather than mass, action contest, all opt-in plaintiffs in Rodriguez v. Niagara Cleaning Services, Inc., 2010 WL 2573974 (S.D. Fla. June 24, 2010), were required to produce their SS#s to the defendant.  Id. at *4.  The class action opt-in forms were court ordered and consented-to by plaintiffs’ counsel.  Id.  “Accordingly, the Plaintiffs may not unilaterally alter the Court’s Order by redacting portions of the Consent to Join Form.”  Id.

In Hinkle v. Continental Motors, Inc., 2018 WL 100965911 (M.D. Fla. April 18, 2018), the court ordered personal injury plaintiffs to turn their SS#s over to the defendant.

[T]hey have refused without any good reason.  Clearly, Plaintiffs should have disclosed this and will be required to do so.  To safeguard the Plaintiffs’ personal identification information, a protective order is appropriate.

Id. at *1. (citation omitted).  Hinkle followed Gober v. City of Leesburg, 197 F.R.D. 519 (M.D. Fla. 2000).  Gober rejected the proposition that a plaintiff’s SS# was privileged from discovery:

Plaintiff has not identified a privilege that appears to be recognized under [applicable] law.  Therefore, to the extent that Plaintiff’s objection to the deposition question is based on a “financial privilege,” [it] is due to be overruled and Plaintiff is ordered to disclose the requested information. . . .  Plaintiff’s social security number, is relevant and is reasonably calculated to lead to the discovery of admissible evidence.

Id. at 520-21.  See Id. at 522 (imposing sanctions because “the Plaintiff’s social security number is not privileged information and may be calculated to lead to the discovery of admissible evidence”).

Similarly, Breslin v. Dickinson Township, 2011 WL 1577840 (Mag. M.D. Pa. April 26, 2011), the plaintiffs could not withhold their SS# in an effort to stymie the defendant’s investigation of their medical histories.

Defendants are entitled to obtain the Plaintiffs’ Social Security numbers. . . .  [Defendants] seek this information in order to obtain medical and military records from third parties.  These records would contain information relevant to the Plaintiffs’ damages claims, . . . since these records would provide medical histories of the Plaintiffs, medical histories which would reveal the extent to which they have suffered physical or emotional distress.

Thus, these medical records have obvious relevance to any damages claims brought by the Plaintiffs that are premised upon physical or emotional distress allegedly caused by the Defendants’ conduct.  Therefore, securing the Social Security account information that is necessary for obtaining these medical records from third parties is clearly a relevant inquiry under Rule 26 of the Federal Rules of Civil Procedure.

Id. at *5.  See Katz v. National Board of Medical Examiners, 2016 WL 2744823, at *2 (Mag. M.D. Pa. May 10, 2016) (“reference to [SS#s] is a necessary element of a third-party subpoena for institutional records concerning an individual such as those sought by the defendants”).

The plaintiff in Heuskin v. D&E Transport, LLC, 2020 WL 1450575 (Mag. D.N.M. March 25, 2020), failed to include his SS# in a release of medical records, thereby preventing the defendant from retrieving any records.  Id. at *9.  Plaintiff claimed this was a mistake, but had not produced the information, so a motion to compel was granted.  Id.  Likewise, in Marks v. U.S. Security. Associates, Inc., 2008 WL 11337996 (N.D. Ala. Dec. 19, 2008), the plaintiff was compelled to produce her SS#, “provided that the parties agree on a protective order.”  Id. at *2.  Accord Archer v. City of Winter Haven, 2017 WL 3840435, at *5 (M.D. Fla. Sept. 1, 2017); Love v. Fairfield Inn & Suites by Marriott, 2011 WL 6012970, at *2 n.15 (S.D. Miss. Dec. 1, 2011); Saunders v. Knight, 2007 WL 1287901, at *2 (E.D. Cal. April 30, 2007); Jones v. J.C. Penney’s Dept. Stores, Inc., 228 F.R.D. 190, 197 n.13 (W.D.N.Y. 2005); Goodman v. City of New York, 2004 WL 1661105 *2 (S.D.N.Y. July 23, 2004); Elkins v. Broome, 2004 WL 3249257, at *2 (M.D.N.C. Jan. 12, 2004), aff’d, 122 F. Appx. 40 (4th Cir. 2005); Magedson v. Fina, 1993 WL 35261, at *4 (N.D.N.Y. Feb. 10, 1993) (all requiring plaintiffs to reveal SS#s, subject to appropriate confidentiality protections).

A plaintiff’s continued failure to comply with SS# discovery can result in dismissal of the action as a sanction.  In Taylor v. Costco Wholesale Corp., 2020 WL 1271579 (D. Nev. March 17, 2020), aff’d, 2021 WL 3721800 (9th Cir. Aug. 23, 2021), the plaintiff was ordered to disclose her SS# but repeatedly refused to comply.  Id. at *1.  Plaintiff’s failure “render[ed] it nearly impossible for [the] case to proceed, because without this evidence, Plaintiff will be unable to prove her damages, and conversely, Defendant will be unable to properly defend itself.”  Id.  Accordingly, plaintiff suffered dismissal, id. at *2, and the dismissal was affirmed on appeal.  Accord Vickers v. Mt. Morris Township Police Dept., 2022 WL 4820423, at *3 (Mag. E.D. Mich. Aug. 17, 2022) (plaintiff’s refusal to disclose SS# required dismissal), adopted, 2022 WL 4715589 (E.D. Mich. Sept. 30, 2022).

Far more often litigated are cases where plaintiffs seek SS# information from defendants, usually for present or former employees who might be witnesses or putative class members.  Because non-parties have not placed waived any privacy rights by commencing litigation, “courts are reluctant to order the disclosure of a witness’ social security number.”  Olson v. Lowe’s Home Centers, LLC, 2024 WL 25089, at *3 (Mag. W.D. Ky. Jan. 2, 2024) (footnote omitted).  “In the case of non-parties, because individuals have a strong privacy interest in their Social Security numbers, such numbers should generally not be disclosed absent a showing of particularized need.”  Karn, 2021 WL 307412, at *5.  Thus, courts “have repeatedly declined to compel production of social security numbers absent a demonstration by the plaintiff ‘with specificity’ that such sensitive information is necessary.”  Ramirez v. Liberty One Group LLC, 2023 WL 4541129, at *9 (S.D.N.Y. July 14, 2023) (citation omitted).

Any suggestion that social security numbers are routinely discoverable as ‘background information,’ is no longer correct, if indeed it ever was” because . . . “the scope of discovery authorized by Rule 26 (without a court order) has more recently been narrowed, and the emergence of identity theft as [a] major problem has led to heightened awareness of the need to deal with social security numbers with greater care.”

Natkin v. American Osteopathic Assn., 2022 WL 19914189, at *4 (Mag. D. Or. May 11, 2022) (refusing to apply Gober to discovery sought from a defendant), adopted in pertinent part, 2022 WL 3974536 (D. Or. Sept. 1, 2022) (quoting Bacchus v. Benson, 2007 WL 9736176, at *2 (N.D. Fla. Nov. 29, 2007)).

Witness SS#s are only discoverable when the requestor has demonstrated their necessity by actual unsuccessful attempts to contact such individuals, and then only under strict confidentiality requirements.  Id.; see Vilella v. Pup Culture LLC, 2023 WL 7986562, at *10 (S.D.N.Y. Nov. 17, 2023) (Plaintiff “has not shown that the contact information . . ., is insufficient to effectuate notice”) (citation and quotation marks omitted); EEOC v. McCormick & Schmick’s Seafood Restaurants, 2012 WL 2577795, at *3 (Mag. D. Md. July 2, 2012) (“social security numbers are private and should only be released on a showing of relevancy and true need for the information.”); Tate v. USPS, 2007 WL 521848, at *3 (Mag. S.D. Fla. Feb. 14, 2007) (plaintiff not entitled to SS# unless showing actual “difficulty locating a witness”).

Thus, there is plenty of available authority that personal injury plaintiffs must provide their SS#s during discovery.  However, Camp Lejeune appears to be the first time the issue has been litigated in the mass tort context.

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For any of our loyal readers looking to start the New Year with a healthy helping of CLE credit, a friendly reminder that four of your bloggers – Bexis, Steven Boranian, Stephen McConnell, and Lisa Baird – will be presenting a free 90-minute CLE webinar on “The good, the bad and the ugly: The best and worst drug/medical device decisions of 2023” on Thursday, January 25th at 12 p.m. EST. The webinar will  provide further insight and analysis on the cases featured in our posts on the worst decisions and best decisions of the past year.

This program is presumptively approved for 1.5 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance. Additionally, please note that CLE credit for on-demand viewing is only available in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Credit availability also expires two years from the date of the live program.

The program is free and open to anyone interested in tuning in, but you have to sign up in advance here.