Can you have federal question jurisdiction in a case where no federal claim is alleged?  The question has a certain self-defining quality to it, sort of like asking if something done under the table can be above board.  Or asking whether the Holy Roman Empire was holy, Roman, or an empire.

We stole that last reference from an old Saturday Night Live sketch, but we have it on much higher authority that, yes, you can have federal question jurisdiction in a case where there is no federal claim alleged anywhere in the complaint.  The U.S. Supreme Court paved the way in Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005), and Gunn v. Minton, 133 S. Ct. 1059 (2013), where the Court basically held that even a state claim can give rise to federal jurisdiction when it necessarily raises substantial federal issues.

The Fourth Circuit’s recent opinion in Burrell v. Bayer Corporation, No. 17-1715, 2019 WL 1186722 (4th Cir. Mar. 14, 2019), explains how Grable jurisdiction works, even if the explanation is a little hostile to the concept and the result is not what the defendant wanted.  In Burrell, the plaintiffs alleged state product liability claims arising from the use of a Class III medical device.  Anticipating that the defendant manufacturer would invoke the Medical Device Amendments’ express preemption clause, the plaintiffs endeavored to plead a “parallel claim,” including that the defendant breached its alleged duty to report adverse events to the FDA and failed to update the product’s labeling.  Id. at *2.

The plaintiff walked into a jurisdictional conundrum that we blogged about here, when the district court in Burrell entered its order finding federal question jurisdiction.  The plaintiff was affirmatively alleging “parallel” claims, i.e., violations of legal duties equivalent to violations of FDA regulations.  Why don’t these allegations—even if characterized as state-law claims—necessarily raise substantial issues of federal law?

The district court found that they did, but the Fourth Circuit has now reversed, and its discussion of Grable jurisdiction is both informative and the first appellate treatment of this particular jurisdictional issue.  Here is the four-part test for determining whether state-law claims give rise to federal question jurisdiction:

To come within [federal question jurisdiction], the case must feature a state-law claim that (1) “necessarily raise[s]” a federal issue, and that federal issue must be “(2) actually disputed, (3) substantial, and (4) capable of resolution in federal court without disrupting the federal-state balance approved by Congress.”

Id. at *3 (quoting Gunn v. Minton, 568 U.S. 251, 258 (2013)).  You can see what this test is going for:  If it walks like a federal question and quacks like a federal question, it’s a federal question.

In application, the Fourth Circuit found that the plaintiffs’ state-law claims did not meet the test.  The anticipated assertion of an express preemption defense did not alone necessarily raise a substantial federal question because “under the well-pleaded complaint rule, . . . our inquiry is limited to the plaintiff’s statement of his own claim; we do not consider affirmative defenses.”  Id. at *5.  As for the plaintiffs’ allegations that the defendant breached duties “parallel” to federal requirements, the court ruled that “so long as even one theory” does not require the interpretation of federal law, resolution of the federal question is not “necessary.”  Id. at *7.

Given that the “parallel” claim allegations were necessary to survive express preemption—which would dispose of the entire case—we are not sure how it could be not necessary to resolve the federal issues.  Even the Fourth Circuit thought “this question was not entirely free from doubt,” so it held instead that the federal issues were not “substantial.”  Id. at *8-*10.  According to the Fourth Circuit, the plaintiff’s claims raised fact-intensive inquiries into the defendant’s compliance with certain FDA requirements, and not pure issues of law that would be important to the federal system as a whole, such as the constitutionality or construction of a federal statute.  Id. at *8.

Finally, the Fourth Circuit ruled that federal question jurisdiction would not be consistent with the “congressionally approved balance of federal and state judicial responsibilities.”  Id. at *9-*10.  On this point, the court noted that Congress had not created a federal cause of action providing remedies for violations of FDA regulations and did not intend “to divert a multitude of fact-intensive, state-law suits against medical-device manufacturers to federal court.”  Id.

We differ with the Fourth Circuit on a few of these points.  For one thing, where the court found “doubt” we clearly see a complaint that affirmatively and necessarily raised federal issues.  We similarly would find those issues to be substantial.  Sure, we are not talking here about the constitutionality of a federal statute, but we are considering the contours of federal laws enacted to provide for the consistent and predictable regulation of life-saving and life-improving devices.  That seems substantial to us.

We also do not believe that finding federal question jurisdiction in this case would disrupt any existing state-federal balance.  To begin with, it makes no difference whether Congress provided a private right of action to enforce FDA regulations.  That was the point of Grable:  Even a state law claim can give rise to federal question jurisdiction; no federal claim is required.  Moreover, with the current and growing masses of medical device product liability cases that currently exist in federal courts—multidistrict litigation, mostly drug/device product liability cases, now makes up more than half the federal docket—what federal-state balance was the Fourth Circuit concerned with disrupting?  We surely have not heard the last of this.

We were wondering when the courts would catch on to this Catch 22.  In order to survive preemption, plaintiffs suing the manufacturers of pre-market approved (“PMA”) medical devices have to allege “parallel claims” in which all “common-law” claims must be genuinely equivalent to violations of FDA regulations. But under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005), and Gunn v. Minton, 133 S. Ct. 1059 (2013), the more “federal” looking the cause of action, the more likely it is to support federal question jurisdiction.

Less than two weeks ago we blogged about an “analogous” GMO case where an agency fraud claim sufficed to support G-G federal question jurisdiction.  Now comes the real thing.  In Burrell v. Bayer Corp., 2017 WL 1032504 (W.D.N.C. March 17, 2017), we no longer need to speak of analogies in considering G-G PMA preemption removal.  To paraphrase Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Burrell IS PMA preemption removal.

Burrell involved the Essure contraceptive device – the other side’s current target in its quest to impose a tort tax on every new form of contraceptive (a phenomenon we discussed here).  Because this product is a pre-market approved medical device, the plaintiff filed a complaint consisting of almost entirely parallel violation claims.  Defendant removed the claim to federal court despite the presence of non-diverse prescribing physicians.  Not even bothering with fraudulent joinder and diversity jurisdiction, the defendant relied solely on federal question jurisdiction under G-G.

G-G jurisdiction involves a three-part test.

First, the action must involve a federal question that was “necessarily raised” as well as “actually disputed.”  Not hard at all.  The plaintiff’s parallel claim “necessarily raises federal law.”  Burrell, 2017 WL 1032504, at *2.

The Complaint is replete with references to the FDA. Federal oversight of the . . . defendants is a necessary part of this case, and plaintiff raises the question of the[ir] . . . duties under the FDCA, as amended by the MDA, and whether they complied with such responsibilities.  Accordingly, the plaintiff’s Complaint necessarily raises federal issues, particularly agency action and the MDA, and the actions of the . . . defendants and health providers under such federal oversight are the subject of this and the related suit.

Id.  The issue was not whether the FDCA created a cause of action itself, but only whether federal law was “necessarily implicated.”  Id.

In order to succeed, the plaintiff must demonstrate that the device or defendants’ conduct deviated from prevailing law.  In the case of the device’s marketing and manufacture, those relevant laws are federal in nature.  Accordingly, they are implicated here and in dispute.

Id. at *3.

Second, the question must be substantial.  Another variant of the prior plaintiff’s argument based on lack of a federal cause of action again failed.  Absence of a cause of action did not mean that the federal aspects of plaintiff’s parallel claim were insubstantial.  The G-G test “explicitly rejected” that equation.  Id. at *3.  Rather,

If the Supreme Court actually intended there to be two pathways to federal question jurisdiction (federally-created or “arising from” federal law), it simply cannot be that the lack of a federal cause of action would foreclose the second pathway.  The lack of a private, federally-created cause of action . . . is far from dispositive if the second pathway (“arising from” federal law) is to be of any real-world application.

Id.  Thus “that there is no private right of action under the FDCA is not dispositive.”  Id. at*4.  Rather, “the dispute is indeed substantial as it challenges the federal oversight of Class III medical device products.”  Id.

Third, and finally, the federal question must be capable of review “without disrupting the federal-state balance.”  The fact of extensive express preemption established where that balance properly lies.  “Congress in this case passed the MDA, explicitly pre-empting state law as a general rule.  It would be farcical to override that explicit Congressional act.”  Id. at *3.

In setting up the MDA, Congress acted with the intent that medical devices would be regulated exclusively by the FDA and state law would be generally preempted.  See 21 U.S.C. § 360k.  Accordingly, it would not upset the federal-state balance to have such claims be brought in federal court.

Id.  “Federal law governs those duties” that plaintiff alleged, such as the supposed “continuing duty to monitor and disclose the true character, quality and nature” of the product.  Id. at *4 (quoting complaint).  All plaintiff’s references to the FDA, necessary to plead a parallel claim under TwIqbal, also tipped the balance in favor of exercising federal jurisdiction.  Id.  “It does not upset the federal-state balance to allow federally-approved medical devices to be sued for alleged safety risks and labeling defects in federal court.”  Id.

That’s how it is done.

The existence of extensive federal preemption, in and of itself, is a strong indication that Congress preferred federal to state court jurisdiction in this aspect of the FDCA.  That plaintiff pleaded claims brimming with FDA standards and allegations of violations of federal law further demonstrated the propriety of federal jurisdiction.  Federal-state balance is not a code word for shrinking federal court dockets, but rather entails balancing the federal and state aspects of the plaintiff’s allegations.

 

As we’ve mentioned before, we watch state-law litigation over genetically-modified organisms (“GMOs”) because they tend to produce interesting results on federalism issues such as preemption, since anti-GMO zealots often try to interpose state law to gum up the works of federal regulatory decisions that they don’t like.  Those results are applicable by analogy (at least to our defense-oriented way of thinking) to litigation in our sandbox that attempts to litigate FDA-related issues in the context of product liability litigation.

The recent decision Bader Farms, Inc. v. Monsanto Co., 2017 WL 633815 (E.D. Mo. Feb. 16, 2017), is such an opinion – on the issue of federal question removability to federal court under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308, 314 (2005).  The plaintiffs in Bader Farms brought state-law tort claims alleging that herbicide “drift” had damaged their crops.  The GMO aspect arose because the herbicide was “old” and the defendant had not provided a new type of herbicide to be used on genetically engineered crops.

Genetically engineered crops are “highly regulated” by the federal government.  2017 WL 633815, at *1.  In this case, the agent was a “plant pest” bacterium so-designated by a federal agency going by the interesting acronym “APHIS” – only a one-letter keyboard typo away from “aphid,” which would have other agricultural connotations.

But we digress.

Anyway, APHIS can “allow[] the commercialization and sale” of genetically modified seeds for agricultural use “only after a strenuous investigation process and only based on sound science.”  2017 WL 633815, at *1-2.  According to plaintiffs, herbicides for such GMOs are “custom[arily]” released at the same time as “complete crop system[s].” Id. at *2.  Plaintiffs’ injury claim was based on the allegation that the defendant released seeds for a genetically engineered crop, but did not simultaneously release a new herbicide − resulting in the “old” herbicide being used. Id.

Bader Farms was non-diverse, but the defendant removed it to federal court anyway, alleging Grable-based federal question jurisdiction, id. – something our drug/device clients have also attempted, unfortunately with limited success.  However, in Bader Farm the defendant succeeded and the removal stuck.  The court’s Grable rationale should prove useful to our clients as well.

One count of the plaintiffs’ complaint, for “fraudulent concealment,” “present[ed] a substantial federal question” under Grable.  Id. at *2.  That was all that was necessary to deny remand, whether the other counts were preempted (or not) didn’t matter:

The fraudulent conduct alleged in the petition is that “[defendant] knew of [APHIS’s and others’] ignorance of the truth and intentionally withheld the truth about its product and its risks,” and that “[defendant] intended that [APHIS and others] should act in ignorance in carrying out their…oversight responsibilities.”

Id.  That sure sounds like an allegation of fraud on a federal agency – and indeed the citation of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), in Bader Farms was how we became aware of the decision.

The fraudulent concealment allegation was premised on plaintiffs’ assertion of a duty allegedly owed to the federal agency APHIS. “Plaintiffs must necessarily prove . . . that [defendant] had a duty to inform APHIS regarding the” risk in question.  2017 WL 633815, at *3.  Whether such a duty was owed to a federal agency constituted a substantial federal question justifying removal:

[P]laintiffs cannot dictate what duty was owed to APHIS, nor what kind of information should be material to APHIS’s decisions.  Nor can plaintiffs dictate the criteria under which APHIS was purportedly unable to perform its regulatory duties.

Id.  Rather, “the information [defendant] is required to disclose” was “set out in federal regulations.”  Id. (regulatory citations omitted).

The Buckman citation in Bader Farms did not involve preemption (the court did not have to reach that issue to deny remand), but instead concerned state-law litigation over what duties that the defendant owed to APHIS, the relevant federal regulatory agency.  Buckman held that “whether federal regulatory bodies fulfilled their duties with respect to the entities they regulate is ‘inherently federal in character.’”  2017 WL 633815, at *3 (Buckman citation omitted).  This type of question was both “substantial” and “federal”:

Count VII [for fraudulent concealment] is in a way a collateral attack on the validity of APHIS’s decision to deregulate the new seeds.  Despite plaintiffs’ argument that they are not challenging the agency decision itself, they can only succeed on that count if they establish that the agency decision was incorrect due to defendant’s fraudulent concealment.  Under these circumstances, disposition of Count VII presents a substantial federal question.

Id. (emphasis added).  Since “the outcome of the fraudulent concealment claim necessarily depends on the interpretation and application of the federal regulatory process,” remand was denied solely due to a substantial federal question in that one count.  Id.

An argument similar to Bader Farms can be made in drug/device cases where fraud on the FDA is alleged, even though a preemption defense, by itself, might not be sufficient to support removal.  As in Bader Farms, allegations that information was concealed or withheld from the FDA would require a court in an ostensibly state-law action to decide if the defendant had a duty, under relevant regulations, to supply the information in question and whether the information was “material” under the FDCA scheme.  Likewise, such claims only cause injury if the “agency decision was incorrect” as found by a state-law jury.  Thus, as in Bader Farms the substantial federal question would not be preemption, but rather the scope of disclosure duties owed to the FDA and whether or not those duties were met.  Finally, removability needs nothing more than that agency-fraud-based claim to succeed – whether that claim, or any other pleaded claim, was preempted (or “completely preempted”) isn’t decisive on the removal/remand issue.

Even though Buckman was decided back in 2001, plaintiffs still like to plead fraud on the FDA – even though Buckman preempts such claims.  But the availability of a federal preemption defense alone has not been enough in so many cases to support removal.  Bader Farms shows the value of focusing on a different federal issue, the nature of the duty owed to the FDA, as the substantial federal question.  Nor can plaintiffs “fix” things by amending out the offending count, as removability is determined at the moment of removal.

Now, at least in the Eastern District of Missouri, there is persuasive precedent supporting removal of agency fraud claims as presenting substantial federal questions.

In honor of Buddy Ryan, the legendary football coach who passed away last week, we will be especially crotchety in today’s case report.  It was while we were in law school in Chicago that Ryan was the coordinator of a Bears defense that was magnificently ferocious.  When the 1985 Bears won the Super Bowl, Ryan was carried off the field.  Never before or since has an assistant coach been so honored.  Ryan later went to Philadelphia, as did we.  (His arrival was slightly more ballyhooed.)  Ryan became the most beloved Eagles coach ever, though his teams never mustered a single playoff win.  Ryan is so revered here because he built a defense that fit the city’s self-image – blue collar and brutal.  It was fun watching Reggie White, Jerome Brown, Clyde Simmons, and Mike Golic maul quarterbacks.  It was fun watching Andre Waters and Wes Hopkins terrify opposing receivers.  It was fun watching linebacker Seth Joyner wreak havoc all over the field.  It was less fun watching an Eagles offense that defined the word erratic.  Aside from achievements on the field, Ryan cut the ultimate figure of pure orneriness.   He was a genuine hero in the Korean War (fighting alongside Dan Blocker, who later played Hoss in Bonanza).  Sports-and-war analogies are overused and overheated, but Ryan’s coaching style was undeniably bellicose.  He put a bounty on Dallas Cowboy players, rewarding his players for maiming America’s team.  Ryan once punched a fellow coach on the sidelines.  He had such contempt for a player that he offered to trade him for a six-pack, and the beer didn’t “even have to be cold.” Philly is a hard-core union town, and Ryan earned big-time props by refusing to coach scab players during a NFL labor dispute. Ryan guested on one of Philly’s notoriously hostile sports-talk shows and, after a caller criticized a trade, Ryan said something like, “Gee, I’m all broken-up about your opinion.”

We’re all broken up about the opinion in Oregon v. General Nutrition Corp., 2010 U.S. Dist. LEXIS 78038 (D. Oregon March 30, 2016).  It is not a drug or device case, but its treatment of removal and federal question is relevant for our work, and not in a good way.  The state of Oregon brought an action in Oregon state court (talk about home field advantage) alleging that the defendant had misrepresented that certain products were “lawful dietary supplements” when they actually contained substances forbidden (according to the state) by federal law.  While the claims were brought under Oregon law, those claims also referenced, indeed, completely turned on, an interpretation of the federal Food, Drug and Consumer Act.  The defendant removed the case to federal court.  Oregon moved to remand back to state court.  The issue was whether there was federal jurisdiction.  Both species of federal jurisdiction were in play here, federal question and diversity jurisdiction.   We will devote this piece to federal question jurisdiction, because the diversity issue is too squirrely. (In brief: a state as party cannot support diversity jurisdiction, so the defendant needed to show that the state was not the true plaintiff.  The court did not buy this argument.)

It sure seems like Oregon was raising a federal question.  Were the substances at issue permitted or forbidden by federal law?  You’ll never learn the answer to that question from this opinion.  Presumably (but, as you’ll see, we’re against presuming), that intricate issue of regulatory construction will be entrusted to good and true jurors. The court began its jurisdictional analysis with an extended riff on the “strong presumption” against finding removal jurisdiction.  We get loads about how the “burden of establishing federal subject-matter jurisdiction for purposes of removal is on the party seeking removal.”  We’ve heard all this before.  But why is there a presumption against removal jurisdiction?  It is hardly self-evident. Why is the burden on the poor defendant, who never asked to be sued?  Shouldn’t the burden be on the plaintiff, as most burdens are?  You can say that federal courts are courts of limited jurisdiction, but what court isn’t?  When we prosecuted misdemeanor cases in California state courts, we were required to prove that the crime was committed in the court’s county.  Not every case could be brought into that court.  So enough with the limited jurisdiction rationale. Isn’t the discussion of presumptions and burdens nothing more than a judicial fig leaf?  Whenever courts spill ink on presumptions and burdens, they inevitably follow-up with an analysis that claims the issue isn’t even close.  The presumption was not necessary at all, was it?

Continue Reading Why is Federal Question Jurisdiction Such a Mess?

One of our correspondents just alerted us to an important decision from the EDNY in Bowdrie v. Sun Pharma. Indus., No. 12-CV-853(WFK)(MDG) (E.D.N.Y, Nov. 9, 2012) (Slip Op.).  The court denied plaintiffs’ motion to remand a generic drug case that involved state law claims but that had been removed by the defendant on federal question grounds.  Generally, you can’t remove a case on federal question grounds if the claims weren’t created by federal law.  But not always.  Sometimes even state law claims are removable if they are based on embedded federal issues that are so substantial that they warrant federal question jurisdiction.  Here’s the Supreme Court in Grable & Sons Metal Prods. v. Darue Eng’g & Mfg., 545 U.S. 308, 312 (2005), addressing that notion:
The doctrine captures the commonsense notion that a federal court ought to be able to hear claims recognized under state law that nonetheless turn on substantial questions of federal law, and thus justify resort to the experience, solicitude, and hope of uniformity that a federal forum offers on federal issues.
We thought that we’d eventually see federal question removal allowed in parallel violation medical device cases because they involve allegations based on specific FDA requirements set out in a PMA.  We blogged about that here.  And we may still see that.  But lo and behold we first get it in a generic drug case.
The Bowdrie plaintiffs claimed that they were injured from the use of the antiepileptic drug Phenytoin Sodium, the generic of Dilantin.  (Slip Op. at 2.)  Plaintiffs alleged that the generic manufacturers had failed to warn because they didn’t use the FDA’s CBE process to update their labels so that they would match Dilantin’s label.  In other words, plaintiffs alleged that the generic manufacturers failed to use an FDA-created mechanism to satisfy a federal obligation.
There’s the embedded federal issue.  Plaintiffs argued that the federal issue wasn’t substantial enough to warrant removal, citing Merrell Dow Pharmas. v. Thompson, 478 U.S. 804, 813-14 (1986), for the proposition that importing a standard from the FDCA is not, by itself, substantial enough to confer federal question jurisdiction.  But the Bowdrie court saw it differently.  There was more involved here.  Plaintiffs did more than just incorporate a federal standard – though we think that this alone may have been enough given the particulars of this case.  They implicated federal labeling requirements nationwide for this particular drug:
In this case, the federal issue involved goes far beyond simply incorporating a federal standard into a state law cause of action.  To the extent they invoke the “federal duty of sameness,” Plaintiffs’ causes of action implicate the labeling requirements for generic drug manufacturers nationwide.  The federal question present in this case involves a responsibility that is in the first instance, and primarily, federal: regulation of the manufacturer, marketing, and distribution of drugs?
(Slip op. at 7)
This decision seems like a pretty big deal.  In essence, plaintiffs who sought to avoid Mensing preemption by stating claims that incorporated federal standards, by doing so, brought themselves into federal court. That’s where we want them.
And for good reason.  Read the rest of the opinion.  The court determined that plaintiffs’ claims were preempted because they wanted the generic manufacturers to match a label that the brand-name manufacturer had submitted via CBE but that had not yet been approved by the FDA.  According to the court, that’s still Mensing preempted:
That either FDA approval of [the brand manufacturer’s CBE label], or a specific FDA directive, is a necessary predicate to generic drug manufacturers’ ability to update labeling, including any medication guide, is consistent with the process by which FDA approval of an ANDA is secured in the first instance.
(Slip op. at 10.)

The court then invoked TwIqbal to dismiss other insufficiently pleaded claims and dismissed the complaint.  Congratulations to defense counsel on a terrific victory.

Things have been weird. What was normal is not now. What has been common recently is not normal. The phrase “the new normal” has been so over-used that hearing it induces a sour look on our face. Somewhere in our brain—like our face, the bloggers have a single, first-person plural brain for stylistic purposes—there is a drive to look for things that are familiar to us. The sun rises in the east. The birds chirp out their vernal tunes. Our dogs care more about barking at interloping canines being walked down the street than defending our vegetable garden from intruding rodents and lagomorphs. Plaintiff lawyers put wacky things in their complaints because they think there is no downside to doing it.

Sometimes there is. In Gremo v. Bayer Corp., No. 1:19-cv-13432-NLH-AMD, 2020 WL 1921952 (D.N.J. Apr. 21, 2020), the plaintiff sued a bunch of companies for alleged injuries suffered from one or more of their gadolinium-based contrast agents used in connection with an one or more MRIs performed on her. (The details on the actual case are sparse in the decision. Her googleable gofundme efforts from years before the case was filed hint that those details could be interesting.)  As might be expected, the plaintiff brought her suit in state court in her home state and included at least one non-diverse defendant. Predictably, the defendants preferred federal court and removed. Not surprisingly, the plaintiff moved to remand.

The sole basis for removal was federal question jurisdiction. This can be a tough issue for the defendants—as we have noted, this areas of law can be messy (as would be seen from various of our posts on the subject)—mostly because the federal question has to be apparent from the face of the complaint and plaintiff lawyers write those. As the Gremo court framed the analysis, federal question jurisdiction lies where “a well-pleaded complaint establishes either that federal law creates a cause of action or that the plaintiff’s right to relief necessarily depends on resolution of a substantial question of federal law.” Id. at *2 (internal citation omitted).

Of course, as we often see when it comes to things like preemption and statute of limitations, the incentive in state court pleadings can be for a plaintiff lawyer to omit the facts that show what really happened. By contrast, at least in federal court and jurisdictions with tighter pleading requirements, the incentive is to offer enough to state claims; although, plaintiffs do tend to get a few chances to do that before any real penalty and they can still try to amend down the road based on discovery. If you put all that together, then there is a path for a plaintiff to stay in state court with an initial complaint that is less than forthcoming about just how much her “right to relief necessarily depends on resolution of a substantial question of federal law.”

The plaintiff in Gremo did not follow that path and the court denied the motion to remand, probably setting the stage for inevitable fight over preemption to be decided by a federal court (where similar cases have gone away based on preemption). In paragraph 126 of her complaint—we suspect it had more paragraphs, but that is the highest numbered paragraph cited in the decision—plaintiff asserted:

Upon information and belief, the Defendants have or may have failed to comply with all federal standards and requirements applicable to the sale of GBCAs including, but not limited to, violations of various sections and subsections of the United States Code and the Code of Federal Regulations.

Id. This followed up on earlier allegations that FDA and “the GBCA industry” had not “acknowledg[ed] any untoward health effects from gadolinium retention in non-renal patients,” and “to date, the FDA and the GBCA industry have refused to acknowledge that GBCAs can cause” a variety of potentially severe injuries. Id. at *3. This was more than enough to satisfy both parts of federal question analysis.

By alleging that the defendants had violated “various sections and subsections of the United States Code and the Code of Federal Regulations” and had not complied with “all federal standards and requirements applicable to the sale of GBCAs,” the plaintiff left no doubt that her claims allegedly arose under federal law. She could not benefit from her complaint’s omission of the specific federal laws, regulations, standards, or requirements at issue or the legal theory allowing her to recover for any violation.

Under the well-pleaded complaint rule, Plaintiff’s allegation that Defendants’ actions taken in concert with a federal agency violate federal law and federal regulations readily establishes that Plaintiff’s complaint arises under federal law. To hold otherwise would require the Court to ignore Plaintiff’s express averment that Defendants’ actions violate federal law.

Id. at *4. This came with a tidy footnote that quoted Buckman on how interaction between FDA and an entity that it regulates was “inherently” a federal issue. Id. at *4 n.4. It is not clear what motivated the plaintiff to include allegations about bad actions by FDA when she could have focused her allegations against the entities she was suing, but she was the “master of her complaint,” for good or bad.

Her perhaps unnecessary allegations also satisfied the second potential basis for federal question jurisdiction.

Plaintiff’s allegations concerning the collusion between the FDA and the GBCA industry for failing to provide proper warnings of the dangers of GBCAs give rise to Plaintiff’s claims against Defendants, which claims plainly depend on the resolution of a substantial question of federal law, even if Plaintiff herself had not expressly stated that such actions violate federal law.

Id. at *5. It did not matter that her complaint also asserted state law claims. “Plaintiff’s claims based on state law may supplement, but they do not erase, Plaintiff’s allegations regarding Defendants’ federal law violations.” Id. That sensible approach from the court is as reassuring as it is to see a plaintiff overreaching, like normal.

 

Strict liability is not the same as absolute liability.  We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way.  The key separator between strict liability and absolute liability is comment k to section 402A of the Restatement (Second) of Torts (1965), which observes that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”  Think of dynamite, for example.  More pertinent to our practice area, comment k included prescription drugs and vaccines among its examples.  But it did not mention medical devices.  That is probably because comment k antedated anything approximating the degree of regulation of medical devices we enjoy today.  In any event, we are left with this question: does comment k apply to medical devices?  If so, which ones?

This is not the first time that we have faced this issue.  Back in 2011, we authored a magnum opus called “Comment k, Some of the Way.”  To this day, it is one of our most widely read posts.  The question keeps cropping up, as product liability plaintiffs keep trying to minimize the scope of comment k.  One simple way of bifurcating judicial treatment of comment k is “across-the-board” versus “case-by-case,” but that misses some nuances.  In 2015, in a post charmingly entitled “How Does a Bad Idea Get Implanted?” we blasted the commonplace California plaintiff argument that comment k applied to medical devices only if they were implantable.  As we demonstrated, that argument lacked sense and support, and the real issue should be whether the medical device required a doctor’s prescription. Tongue depressors come with neither prescriptions nor comment k protection, but, say, medical lasers should come with both.  In 2017, we revisited the issue to look beyond California, finding cases in other jurisdictions applying comment k to medical devices. It is an important issue, and it keeps surfacing.  Here is another post where we scrutinized the contours of comment k. So, is it unusual for courts to apply comment k to medical devices?  Not at all.  Take a look at our favorite reference book, Beck/Vale, Drug and Medical Device Product Liability Deskbook, section 2.02[2] and footnote 14.  There are literally hundreds of cases that have applied comment k to medical devices, in the same way they apply it to prescription drugs. 

Recently, the scope of comment k surfaced in Burningham v. Wright Med. Grp., Inc., 2018 U.S. Dist. LEXIS 10726 (D. Utah Jan. 23, 2018).  In that case, the plaintiff alleged injuries from an implanted hip device.  The design defect claims were premised on a theory of strict liability.  The defendants argued that the hip implant was an “unavoidably unsafe” product and was, therefore, categorically barred from design defect claims. Utah law controlled and the Utah Supreme Court has adopted the comment k “unavoidably unsafe products” exception to strict products liability.  But while the Utah Supreme Court has explicitly applied comment k to prescription drugs (categorically, not case-by-case), it has thus far been silent on whether comment k reached medical devices.  The defendant in Burningham argued that the doctrine regarding unreasonably unsafe products should apply equally to the medical device at issue.   

The Burningham case has traveled a circuitous path through the judicial system.  It was filed in California state court, then became part of a coordinated proceeding, then was released from that proceeding, then was moved by consent to the federal court in Utah.  Meanwhile, there is a federal MDL in Georgia dealing with design defect claims against these same hip implants.  Not so long ago, we authored a screed against a decision in that litigation involving what we saw as a complete misreading of Utah law on … wait for it .. comment k.  The Georgia federal court did not apply comment k to the medical devices and, just for good measure, completely mangled Utah law on design defect.  We were disappointed. Then the Eleventh Circuit affirmed the horrible result and wretched reasoning.  We were disappointed again.

So we have some history with this topic.

You will not be surprised to hear that we agree with the defense argument that Utah law should and would include hip implant medical devices as “unavoidably unsafe” products warranting comment k protection. The Burningham court stated that the defendant pointed “to decisions from courts in Oklahoma, Washington, California, and Pennsylvania, which do apply the doctrine to implanted medical devices.”  Yikes – there’s that unnecessary/wrong restriction to implanted devices, but since the devices in Burningham definitely were implanted one can see why the defendant in that case would take the most conservative approach.  If the federal court was going to try to predict which way the Utah Supreme Court would go, the broader reading of comment k, which would include medical devices, would probably prevail. But because the “question of whether the categorical exception applies to implanted medical devices is a question of first impression for Utah courts,” the federal court sua sponte (on its own) decided to issue an order certifying the issue to the Utah Supreme Court.  Our bet is that the defense will persuade the Utah court to extend comment k to medical devices.  Just don’t dig in too hard on the question of implantation.  Leave us room later to argue that comment k should apply to all prescription medical devices, please-and-thank-you.

Meanwhile the federal court was in a perfectly fine position to dismiss the misrepresentation and breach of warranty claims for lack of reliance.  The complaint supplied conclusory allegations of generalized reliance, but never listed any factual allegations that the plaintiff or his doctors “actually read or saw Defendant’s misrepresentations” and the complaint contained “no allegation that the Defendants’ express warranties were ever communicated to Plaintiffs or Mr. Burningham‘s physicians.”  The complaint could not “withstand the Twombly/Iqbal analysis.”  So much for those claims, and now it is up to the Utah Supreme Court to read comment k correctly and pave the way for dismissal of the strict liability claims. 

 

Today we discuss a putative class action in which the named plaintiffs are a registered nurse who refuses to take a basic precaution to protect her vulnerable patients and a mother who is more interested in displaying her livestock than protecting her neighbors. Brought on behalf of all New Mexico residents who are equally selfish, the plaintiffs sought an injunction barring the state from enforcing a public health order that requires (with limited exceptions) all hospital, nursing-home, assisted-living-facility, adult-day-care, rehabilitation-facility, and prison workers, all employees of the governor’s office, and all who would enter the New Mexico State Fair grounds to be vaccinated against the SARS-CoV-2 virus, which causes COVID-19. The plaintiffs asserted various constitutional and statutory claims. In a thorough and trenchant decision, Valdez v. Grisham, — F. Supp. 3d —-, 2021 WL 4145746 (D.N.M. 2021), a federal district court rejected them all. That is consistent with long-standing precedent and other recent decisions—as we discussed here, here, and here.

The plaintiffs’ first claim was that requiring them to be vaccinated with “experimental” vaccines violated the FDCA. The claim was predicated on the fact that, at the time suit was filed, the three SARS-CoV-2 vaccines available in the United States—the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines—had not received full FDA approval and were instead being distributed and administered under Emergency Use Authorizations (EUAs). The plaintiffs claimed that requiring them to be vaccinated violated the terms of the vaccines’ EUAs, which require that those receiving each vaccine be informed of its “benefits and risks” and “of the option to accept or refuse” its administration. 2021 WL 4145746, at *4.

The court rejected the plaintiffs’ FDCA claim.

Implicitly responding to the plaintiffs’ assertion that the vaccines were “experimental,” the court recited at the outset both the extensive testing that each had undergone before the EUAs were granted, including “at least one well-designed Phase 3 clinical trial that demonstrate[d] the vaccine’s safety and efficacy in a clear and compelling manner,” and the fact that “[c]omprehensive data collected since the three vaccines received EUA status demonstrates that they are safe and highly effective in preventing infection and severe illness, and that serious adverse side effects from the vaccines are exceedingly rare.” 2021 WL 4145746, at *1. The court further observed that, “despite Plaintiffs’ protestation to the contrary, the FDA has now given its full approval—not just emergency use authorization—to the Pfizer vaccine” for administration to those 16 and older. Id. at *4. That did not moot the plaintiffs’ statutory claim, however, because the livestock-display-over-human-health plaintiff asserted the claim on behalf of not only herself but also her 11- and 12-year-old children, who were also keen to “show[] their animals” at the state fair. Id. at *2.

Addressing the merits of the plaintiffs’ FDCA claim, the court found that there were none. It explained that although the EUAs issued pursuant to the FDCA require “medical providers” administering the vaccines to inform would-be recipients of the risks associated with each vaccine and their right to refuse it, the EUAs do not prohibit the state from requiring individuals, duly informed by their medical providers, to be vaccinated. Id. at *4. In so holding, the court cited both Bridges v. Houston Methodist Hosp., 2021 WL 2399994, at *2 (S.D. Tex. 2021), which rejected a nearly-identical anti-vaxxer claim on the ground that the FDCA “neither expands nor restricts the responsibilities of private employers” and “does not confer a private opportunity to sue the government,” and a recent Department of Justice Office of Legal Counsel memorandum opinion concluding that the FDCA’s informed-consent provision “specifies only that certain information be provided to potential vaccine recipients and does not prohibit entities from imposing vaccination requirements.”

Having dispensed with their statutory claim, the court proceeded to dispense with the plaintiffs’ constitutional claims—brought under the Due Process, Equal Protection, and Contract Clauses.

Asserting a violation of their right to substantive due process, the plaintiffs alleged that they “‘have [constitutionally] protected liberty interests’ ‘in their right to live without governmental interference,’ their right ‘to bodily integrity,’ their right ‘to raise their children as they see fit,’ and their right ‘to engage in their chosen professions,’ and that because the state’s public health order is ‘not narrowly tailored,’ it violates these substantive due process rights.” 2021 WL 4145746, at *5.

Relying on well-established constitutional precedent, the court explained that a two-part analytic framework applies when a legislative enactment or executive action is challenged on substantive due-process grounds. The first step is to identify the “fundamental liberty interest” purportedly at issue. The second step is to determine whether that interest “is ‘deeply rooted in this Nation’s history and tradition’ and ‘implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if they were sacrificed.’” 2021 WL 4145746, at *5 (indirectly quoting Washington v. Glucksberg, 521 U.S. 702, 720–21 (1997)). If the asserted liberty interest meets that standard, then the government may not infringe it “‘unless the infringement is narrowly tailored to serve a compelling state interest.’” Id. (quoting Glucksberg, 521 U.S. at 721). If, by contrast, the legislative enactment or executive action “does not implicate a fundamental right,” the action is permissible if it “bear[s] a rational relationship to a legitimate government interest.” Id. (quotation marks omitted).

The court found that the plaintiffs did “not explain how the rights allegedly violated by the [public health order] are fundamental.” 2021 WL 4145746, at *5. “[I]ndeed nowhere,” said the court, did the plaintiffs “address how the right to work in a hospital or attend the State Fair, unvaccinated and during a pandemic, is ‘deeply rooted in this Nation’s history and tradition.’” Id.

In their request for preliminary relief, the plaintiffs relied on “the right to ‘engage in their chosen profession.’” 2021 WL 4145746, at *5. That, however, was no help to them, the court held, because “the Tenth Circuit”—the circuit within which the court sits—”has unequivocally held that the ‘right to practice in [one’s] chosen profession … does not invoke heightened scrutiny.’” Id. (quoting Guttman v. Khalsa, 669 F.3d 1101, 1118 (10th Cir. 2012)). Thus, said the court, “while Plaintiffs may ‘have a right to engage in their chosen professions,’ governmental infringement on this right will be “‘presumed to be valid’” so long as it is “‘rationally related to a legitimate state interest.”’” Id. (quoting Klaassen v. Trustees of Indiana Univ., 2021 WL 3073926, at *17 (N.D. Ind. 2021), in turn quoting City of Cleburne v. Cleburne Living Ctr., 473 U.S. 432, 440 (1985)).

Moreover, said the court, “federal courts have consistently held that vaccine mandates do not implicate a fundamental right and that rational basis review therefore applies in determining the constitutionality of such mandates.” 2021 WL 4145746, at *5. Applying that standard, the court rejected the plaintiffs’ substantive due-process claim, concluding that “[t]he vaccination requirements set forth in the [New Mexico public health order], … grounded in medicine and science, are rationally related to [the state’s] legitimate purpose of protecting our community ‘against an epidemic of disease [that] threatens the safety of its members.’” Id. at *8 (quoting Jacobson v. Massachusetts, 197 U.S. 11, 27 (1905)).

As Bexis did last month, the Valdez court explained that “[w]ith its decision in Jacobson”—which upheld “a Cambridge, Massachusetts regulation that required all adult inhabitants of that city, without exception, to be vaccinated against smallpox”—“the Supreme Court ‘settled that it is within the police power of a state to provide for compulsory vaccination.’” 2021 WL 4145746, at *6–7 (quoting Zucht v. King, 260 U.S. 174, 176 (1922)).

All that is necessary for state action to survive the “rational basis test” is that it bear “a rational relationship to a legitimate government interest.” Glucksberg, 521 U.S. at 721. The Valdez court found that New Mexico’s vaccination requirements did more than that, concluding that “[t]he governmental purpose of stemming the spread of COVID-19, especially in the wake of the Delta variant, is not only legitimate, but is unquestionably a compelling interest.” 2021 WL 4145746, at *7 (quotation marks omitted).

Having rejected plaintiffs’ substantive-due-process claim on the ground that that the New Mexico public health order requiring certain people to be vaccinated against SARS-CoV-2 “meets the rational basis test” (2021 WL 4145746, at *8), the Valdez court quickly disposed of the plaintiffs’ remaining constitutional claims. It concluded that the plaintiffs’ equal-protection, procedural-due-process, and impairment-of-contract claims were also subject to rational-basis review and that they therefore failed for the same reasons as the plaintiffs’ substantive-due-process claim. Id. at *9–11.

Finding that plaintiffs were unlikely to prevail on the merits of their claims, and that the remaining equitable factors likewise cut squarely against them, the court denied the preliminary injunction that the plaintiffs requested.

Onward to full vaccination.

We have news to report.   No, we don’t mean the resignation of New York’s governor, though we can’t say we’ve shed many tears.  And we certainly don’t have much good news about Greece, where we are supposed to be headed in a few weeks.  Between Delta (Greece is now back in the CDC’s “Level Four”)  and the catastrophic fires in Greece and Turkey that have filled the skies over our destination island with dense smoke, Greece is suffering through scary and challenging times, and we are keeping that beautiful country and its people in our thoughts.

Our news is of the first-world professional sort, but it is right in our wheelhouse and has the potential to benefit all of us who represent medical device manufacturers.  (It has the opposite potential, too, but we are in a glass-half-full mood.)   As we lamented a little over a year ago, in a post about a case called Ebert v. C.R. Bard, 2020 WL 2332060 (E.D. Pa. May 11, 2020) (as well as here and here and here and here), Pennsylvania’s federal district courts have spent the past several years in a ludicrous and unnecessary debate.  Courts have split over whether the “unavoidably unsafe product” exception of comment k to Section 402(A) to the Restatement (Second) of Torts, which expressly bars strict liability design defect claims against manufacturers of prescription drugs, also bars those claims against manufacturers of prescription medical devices.  Why is this debate ludicrous and unnecessary?  Because there is no conceivable basis on which to draw a principled distinction between prescription drugs and prescription medical devices for purposes of comment k’s exemption.  Of course comment k bars strict liability claims against device manufacturers.  There is no colorable argument otherwise, and decades of Pennsylvania appellate jurisprudence (stopping short of the Pennsylvania Supreme Court, but stay tuned) agrees with us.

Ebert went the wrong way on the comment k question.  But it went the right way on another disputed issue:  the scope of the Pennsylvania Supreme Court’s 2014 Lance decision, which held, for the first time, that negligent design defect claims are cognizable in prescription drug cases.  (Pennsylvania’s federal district courts broadened the holding to apply to prescription medical devices.) The Ebert court agreed with the defendants that the relevant duty of care is narrow – that manufacturers breach their duty only if they introduce into the marketplace a drug that is too harmful to be used by anyone.  (The plaintiff disagreed, citing language from Lance to the effect that the duty can be viewed as a continuum with breaches of duty possible all along the continuum.)

Last month, we told you that the Third Circuit had certified both questions to the Pennsylvania Supreme Court.  Just last Thursday, the Supreme Court granted review of both questions.  The Order states:

The Court shall consider the following issues:  (1) Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may the plaintiff also prevail on other theories of liability where appropriate? (2) Under Pennsylvania law, are prescription implantable medical devices categorically subject to strict liability, categorically immune from strict liability, or immune from strict liability on a case-by-case basis? If they are immune on a case-by-case basis, what test should a court apply to determine whether a particular device is immune?

We are watching anxiously, cautiously hopeful that the Court will adopt the narrow construction of Lance and will hold that comment k applies across the board to bar strict liability design defect claims against prescription medical device manufacturers.  (Our personal opinion is that applying comment k on a case-by-case basis is of little value, as this analysis nearly always involves fact issues that preclude summary judgment.)  We will let you know as soon as the Court decides the appeal.  We may even attend the argument, if it is “in person,” and we will let you know if we do.  In the meantime, stay safe out there.

It’s a Sunday night after an incredibly jam-packed weekend of activities.  The family, mother, father and two teens, decide to end the weekend with a movie.  A nice wind down before another hectic week begins.  A few minutes in, the father remarks:  don’t I know that actress from something else?  To which mother offers – wasn’t she the one who did the thing in that other movie.  Father:  No, no.  I think she was on Law and Order (as if that narrows it down).  After a few similar volleys ranging from Downton Abbey to The Fast and the Furious, the teens can no longer hold their tongues.  They’ve got the answer from Google, IMDB, Wikipedia and any other number of sources readily accessible via that device that is never out of reach.  The parents could have done that too and would have eventually.  But where’s the fun in that?  The fun in seeing if you can pull the memory from some dark and dusty corner of your brain.  Afterall, when the parents were teens that was the only option.  Which often led to heated debate based on nothing more than vague recollections.  That’s fine when the topic of discussion is who played Ramona Flowers in Scott Pilgrim vs. the World.  But it’s not okay when the question is what the FDA would do.

That’s a question the court in Azurity Pharms, Inc. v. Edge Pharma, LLC, 2021 U.S. Dist LEXIS 95300 (D. Mass. May 18, 2021) was unwilling to guess at.  Plaintiff is the manufacturer of an antibiotic.  Defendant is a compounder – a facility that mixes or combines ingredients to make medication.  However, the FDA prohibits compounders from compounding drugs that are “essentially a copy of an FDA-approved drug.”  Id. at *2.  That is what plaintiff said defendant was doing – copying one of their antibiotics and falsely marketing that defendant was complying with FDA regulations.  Id. at *1.  Plaintiff claimed that the false statement gave rise to an action under the Lanham Act and the Massachusetts consumer protection statute.

In other words, plaintiff wanted the court to decide whether defendant was violating the FDCA by compounding a drug that was “essentially a copy” of plaintiff’s product.  Id. at *4.  Importantly, that’s a question the FDA has not addressed.  The FDA has not issued any decision finding the defendant is non-compliant with the compounding regulations.  Because enforcement of the FDCA is “largely committed to the FDA,” this is a circumstance where the FDCA precludes a Lanham Act claim:

Because the FDCA forbids private rights of action under that statute, a private action brought under the Lanham Act may not be pursued when, as here, the claim would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that there was such a violation.

Id. at *5 (quoting PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924 (9th Cir. 2010)).  It’s not preemption because the Lanham Act is a federal statute, but the underlying basis – private attempts to enforce the FDCA are prohibited – is an issue near and dear to our hearts.  The court was not willing to resolve the “thorny question” of what constitutes an “essential copy” under the FDCA.  That’s an issue for FDA expertise.  Id. Because plaintiff’s consumer protection claims were premised on the same allegations, they likewise were dismissed.  Id. at *6.

And, if you are wondering who played Ramona Flowers (and haven’t googled it already) it is Mary Elizabeth Winstead.  Which happens to have led to a whole conversation about actresses named Mary who go by three names – Louise Parker, Elizabeth Mastrantonio, Tyler Moore, Stuart Masterson, Kay Place.  You can decide who your favorite is.