It’s hard to believe, but fully five months after COVID-19 was officially declared to be a “pandemic,” it’s still extraordinarily difficult to get oneself tested – particularly if one is not already sick or exposed.  Maine has been one of the most successful states in reducing the virus’ spread, with the third lowest rate of infection in the country.  One of the requirements Maine has imposed is that anyone visiting (except from a few other low-incidence states) must quarantine for 14 days.  “Adults who have a negative COVID-19 PCR test collected no more than 72 hours before arriving in Maine” are exempt.  Just try to find someplace to schedule such a test.

Bexis, whose wife has a shore cottage in Maine, tried for the last couple of weeks to arrange a COVID test that would comply with the Maine requirements.  Can’t be done in Pennsylvania or South Jersey, because pre-scheduled well-adult testing that would meet Maine’s 72-hour limit is not publicly available.  The feds?  Don’t make us laugh.  Despite occasional claims that “anybody that needs a test can get one,” that just ain’t so.  The federal government has abandoned any pretense of providing the kind of immediately available testing that is found in parts of Europe.  So Bexis’ annual Maine trip is off.

Speaking of travel issues, what happens when a case travels?  MDL transfer orders collect hundreds, even thousands, of cases from all over the country and send them to one particular court.  The MDL court then issues numerous substantive orders – some of great import − that affect all of these cases.  Not all MDL cases settle; sometimes remanded cases themselves number in the thousands.  So how does one go about challenging the validity of an MDL ruling on appeal after the case has been remanded to a district court in a different circuit?

That’s what the Eleventh Circuit recently had to determine in Corley v. Long-Lewis, Inc., ___ F.3d ___, 2020 WL 4006602 (11th Cir. July 16, 2020).  Corley had been in the Asbestos MDL in the Eastern District of Pennsylvania, which as most readers undoubtedly know, is in the Third Circuit.  While in the MDL, a number of defendants (referred to as “Navy suppliers”) obtained summary judgment on the statute of limitations.  Id. at *1.  Belatedly, plaintiff attempted to assert maritime law, which had a longer statute of limitations, but the MDL court held that the “motion for reconsideration was far too late.”  Id.

Eventually, the suit was remanded to the Northern District of Alabama, which is in the Eleventh Circuit (there is also no seacoast in northern Alabama, but that’s where plaintiff filed).  After further motions, settlements, and bankruptcies, plaintiffs voluntarily dismissed the remaining defendants without prejudice and “filed this appeal, which . . . challenges the denial of their motion to reconsider the summary judgment in favor of the Navy suppliers.”  Id. at *2.  The resulting appeal presented an extremely interesting procedural morass – the subject of our post today.

First up – appellate jurisdiction.  Can a voluntary dismissal create the necessary finality to support a federal appeal?  Ultimately the Eleventh Circuit answered that question “yes,” but not before remarking that “we do not write on a blank slate,” rather “the canvas looks like one that Jackson Pollock got to first.”  Corley, 2020 WL 4006602, at *3.  Corley was hardly the first time a plaintiff had sought to create appellate finality through voluntary dismissal of what had become unwanted claims and defendants, and prior cases were all over the place.  After spending much ink considering prior precedent, Corley resolved the issue in favor of appealability:

Because we cannot harmonize our decisions, the earliest-precedent [governs] rule applies.  And under that rule . . . we hold that an order granting a motion to voluntarily dismiss the remainder of a complaint under Rule 41(a)(2) qualifies as a final judgment for purposes of appeal.

Id. at *5.  Note: the rule that Corley cites – that in the case of intra-circuit conflict among published panel decisions, the earlier decision is controlling – itself appears to be the strong majority rule (using the West keynumber in Corley (106k90(2)) and quickly searching for “earli!” or “oldest” shows the earlier-in-time rule expressly adopted by every circuit court except the First, Second, and Ninth).

Second up – territorial jurisdiction.  Statutorily, “appeals from reviewable decisions of the district . . . courts shall be taken . . . to the court of appeals for the circuit embracing the district.”  28 U.S.C. §1294.  How, if at all, is this statutory command affected by rulings made by an out-of-circuit MDL court prior to remand?  The defendants argued that the substantive order at issue was made MDL court in the Eastern District of Pennsylvania, “which would deprive us of jurisdiction.”  Corley, 2020 WL 4006602, at *6.  That’s an interesting question that could arise in any MDL post-remand case – and there are hundreds of them right now, just those involving mesh.

Well, there is “a circuit split over the application of §1294 to interlocutory orders that precede an inter-circuit transfer.”  Id.  According to Corley (we did not engage in independent research), “[m]ost circuits . . . have concluded that they can review an out-of-circuit interlocutory decision so long as they have jurisdiction over the district court that issued the [ultimate] appealable decision.”  Id. (citing Second, Third, Fifth, Sixth, Seventh, and DC precedent).  Only one circuit, the Tenth, has disclaimed jurisdiction to review interlocutory orders by out-of-circuit district courts, even though the ultimate final appealable order originated in an in-circuit court.  Id.  Corley “agree[d] with the majority interpretation”:

[T]he phrase “reviewable decisions” in §1294 refers to appealable decisions.  Congress has not given us the power to review interlocutory orders at will.  Outside of narrow circumstances not relevant here, we can review those orders only when they merge into a final judgment of the district court.  So even when we consider the merits of an interlocutory order, we still “review” the final decision into which the earlier order merged.

Id. (citations and quotation marks omitted).  Thus, “§1294 concerns ‘appeals from reviewable decisions,’” which presumes that the “reviewable decision[ ]” is an appealable decision.  Id. (citation and quotation marks omitted).  So Corley held that the court of appeals responsible for the transferor court has jurisdiction to review any applicable interlocutory order issued by an MDL court during the period that the case in question was part of that MDL.

Finally, Corley held that the plaintiffs had standing, notwithstanding their filing a voluntary motion to dismiss, because they remained “aggrieved” by the underlying MDL order to which they had “never consented.”  2020 WL 4006602, at *8.

Even though [plaintiffs] are not adverse to the order of voluntary dismissal, . . . they are adverse to the order that denied their motion to reconsider the summary judgment in favor of the Navy suppliers.  And the latter order is just as much a part of the final judgment as the voluntary-dismissal order.  So, notwithstanding their voluntary dismissal, [plaintiffs] are adverse to part of the final judgment, which is enough to establish appellate standing.

Id. (citations omitted).

These procedural issues should be of interest to defense counsel, as they arise in all kinds of tort cases.  In particular, drug/medical device mass-tort defense counsel should pay attention to Corley’s second holding.  Under the “majority rule” that Corley followed, it is more than theoretically possible for a single interlocutory MDL order – jurisdictional, Daubert, preemption, or anything else − affecting all cases in the MDL, to be reviewed several times by several different courts of appeals.  What the MDL court did might even be contrary to the laws of some circuits.  Further, most of these “interlocutory” decisions would probably be defense losses in the MDL context, but not all.  When multiple cases are remanded from an MDL, defense counsel will need to consider them strategically, to determine in which circuit an appeal of an adverse MDL order on – say, preemption – would stand the best chance of success.

We often say, as we said last week, that this blog is not designed to do plaintiffs’ work for them. Thus, we are a heckuva lot more likely to trumpet pro-defense rulings than wrong ones. Still, it is important to know the problem areas out there, and today’s case displays one of them. It relates to personal jurisdiction, where the momentum has very much been in defendants’ favor since the SCOTUS decisions in the Bauman and BMS cases.

In Collett v. Olympus Medical Systems Corp., 2020 U.S. Dist. LEXIS 10170 (M.D. Ga. Jan. 22, 2020), the court held that it could exercise personal jurisdiction over a Japanese parent company that did not actually do anything in Georgia. The Japanese parent company designed and manufactured colonoscopes. It then supplied the colonoscopes to a U.S. subsidiary that distributed them throughout the United States. A plaintiff in Georgia claimed that she had contracted an immunodeficiency virus from a defective colonoscope. She sued both the Japanese parent company and the U.S. distributing company.

The Japanese parent company challenged personal jurisdiction, furnishing an affidavit that it was not responsible for and did not control the marketing, advertising, promotion, sale, or distribution of the colonoscope in the United States, did not transact any business in Georgia, did not derive any direct revenues from Georgia, etcetera, etcetera. That “etcetera, etcetera” sounds like the King’s throwaway phrase in “The King and I,” but take it as shorthand for saying that the Japanese company had nothing to do with Georgia.

The court began its jurisdictional analysis by deciding that the Georgia long-arm statute reached the Japanese parent company because its conduct outside Georgia – the design and manufacture of the colonoscope – caused tortious injury inside Georgia. Moreover, the Japanese company expected that its products would be distributed everywhere in the U.S. – it certainly did not exclude Georgia. Further, at least some of its revenues indirectly came from Georgia.

But what about due process? Under the Bauman case, Georgia clearly could not exercise general jurisdiction over the Japanese company. All the conceptual action in the case concerned whether specific jurisdiction existed. Looking to some of the older specific jurisdiction cases – Burger King, Keegan, Helicopteros, World-Wide Volkswagen – the Collett court reasoned that a forum state does not offend due process by asserting “personal jurisdiction over a corporation that delivers its products into the stream of commerce with the expectation that they will be purchased by consumers in the forum State and those products subsequently injure forum consumers.”

We are not in love with the stream of commerce theory. It too quickly veers into the boundless. It also threatens to make a mockery of recent SCOTUS personal jurisdiction teaching. Speaking of recent SCOTUS personal jurisdiction teaching, the Collett court dispensed with BMS on the grounds that BMS merely excluded personal jurisdiction when the plaintiffs were not residents of the forum state. The plaintiff in Collett, by contrast, was a Georgia resident. Okay, but we think there is a little more to BMS than that. How much more? Lots more. For example, as we recently blogged, BMS means that a defendant cannot be dragged into court based solely on its relationship with a third-party.

The SCOTUS case that really posed a problem for exercising personal jurisdiction over the parent company in Collett is the 2011 J. McIntyre Machinery case. In J. McIntyre, the Supreme Court plurality opinion applied a “stream of commerce plus” test, reversing the New Jersey Supreme Court’s decision that a New Jersey Court could exercise personal jurisdiction over a British manufacturer that sold a single machine to a New Jersey customer through an American distributor but had no other contacts with New Jersey. That “plus” is an additional requirement along the lines of purposeful availment. The Collett emphasized that the SCOTUS plurality was not a majority, and therefore declined to add that “plus” to the stream of commerce test. That is a surprising, and perhaps unnecessary way to go. One could see the Collett court emphasizing the singularity of the transaction in J. McIntyre, and going off on a Hegelian riff on how quantitative differences at a certain point become qualitative. (Not that we would advocate citations to anything by Hegel, who is more opaque than the tax code.)

J. McIntyre is a real barrier to Collett’s outcome because SCOTUS said that a foreign company that markets a product to the United States generally but does not purposefully direct its product to an individual state is not subject to specific jurisdiction in the state where its product causes injury. J.McIntyre and an earlier personal jurisdiction case, Asahi, rejected the view that a foreign company is subject to jurisdiction so long as it could reasonably foresee that the distribution of its products through a nationwide system might lead to those products being sold in any of the 50 states. Not to put too fine a point on it, Collett appears to be on the wrong side of SCOTUS doctrine. At the very least, Collett’s side-step of J.McIntyre via the plurality/majority distinction does not do much to reinforce the strength of the Collett decision.

The Collett court was plainly troubled by the notion that a “manufacturer can escape legal responsibility for any defect in its product because it has decided that its product will be sold generally everywhere but nowhere in particular.” We are not so troubled. This was not an instance of a wrong without a remedy (a dumb concept anyway – even an inattentive student of life knows that wrongs without remedy abound). After all, the plaintiff was able to sue the U.S. distributor. We did not see in the Collett case any allegation of an alter ego relationship between the parent and subsidiary, or that the subsidiary was some sort of insolvent shell or conduit. In Collett, it is as if doctrine was sacrificed out of fear of a nonproblem.

The Collett case came out last January. Around that same time, we blogged about how SCOTUS granted certiorari for a pair of automobile cases that would permit elaboration of the vitality – or non-vitality – of the stream of commerce test for personal jurisdiction. Then came Covid-19 and arguments for those cases were put off until next term. You can read the supremely well-reasoned amicus brief here.

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Shameless Promotion

McConnell, doubtless the grouchiest blogster of the group, has turned his July 22 post on “Watch Your (Deposition) Language” into a webinar. It runs this afternoon and is available thereafter on demand. You can find it here.

So if reading his various scolds about sloppy depositions isn’t enough for you, and you actually want to hear the frustration and exasperation in his voice, be sure to tune in.

We love to read opinions that reach conclusions in a direct and precise manner (more so when we agree with the conclusion).  There is a certain skill in using simple language to convey complex ideas.  In this blogger’s opinion, nobody does it better than Hemingway.  That’s not really going out on a limb; using a Pulitzer Prize and Nobel Prize winning journalist and novelist as the benchmark.  Writing simply isn’t about dumbing things down.  You can’t accuse Hemingway of that.  It’s about making writing accessible and easy to read.  For instance, a statistician who analyzed authors’ writing styles found that Hemingway used less –ly adverbs per 10,000 words than any other writer other than Toni Morrison.  Not bad company to be in.

This praise for simplicity came after reading the decision in Noel v. Bayer Corp., 2020 WL 5038782 (D. Mont. Aug. 26, 2020).  It’s not Hemingway – by any stretch.  But it is simple and straightforward and so we will strive to make our report the same.

The case involves the birth control device Essure, which is a Pre-Market Approved product.  Plaintiff brought eleven causes of action ranging from failure to warn to negligent risk management.  Id. at *1.   The court took them in turn.

Design Defect:  It is “nearly impossible for a design-defect claim to survive pre-emption because such a claim would challenge the FDA-approved design.”  Id. at *3.  Therefore, “[a] claim that Essure’s design is deficient seeks to invalidate the FDA’s approval of the device and is inherently pre-empted.”  Id.  Brevity is the soul of wit.  William Shakespeare.

Manufacturing Defect:  Because plaintiff alleges defendant’s manufacturing of the device did not conform to FDA requirements, the claim is not preempted – doesn’t create a state requirement that is different than or in addition to a federal requirement.  But, plaintiff failed to allege facts establishing causation.  Id. Plaintiff is given a chance to re-plead this claim.  Id. at *10.

Failure to Warn — Traditional:  This claim is preempted because there is

no FDA requirement for [manufacturers] to report consumer complaints directly to healthcare providers and consumers or to update its warnings and labeling as [manufacturers] learn[] of issues with the device.

Id. at *4.  A state cannot make obligatory an FDA requirement that is voluntary.  Id.  Less is more.  Ludwig Mies van der Rohe

Failure to Warn – Failure to Report:  Federal law does require device manufacturers to report adverse events to the FDA.  “However, Montana law provides no such parallel duty.”  Id.  Plaintiff tried to draw an analogy to cases extending a manufacturer’s duty to warn to all foreseeable users (bat manufacturer’s duty to warn extended to other players, not just batter) or to all healthcare providers responsible for a patient’s care, not just the prescriber.  Id.  However, “[a] government regulator is not a foreseeable user or consumer of a product.”  Id.  Simplicity is the ultimate sophistication.  Leonardo da Vinci

Misrepresentation-based claims: “When a claim challenges marketing that complied with FDA-approved requirements” it is preempted “because success on those claims requires a showing that the FDA requirements themselves were deficient.”  Id. at *5.  Therefore, to survive preemption, statements and express warranties “must have gone beyond the statements the FDA approved.”  Id.  The court compared plaintiff’s allegations of misstatements and found them “functionally equivalent to FDA-approved language.”  Id. at *6.  For example, saying implanting the device was “quick and easy” is functionally equivalent to the FDA-approved language that the device is a “simple procedure that can be done in 10 minutes.”  Plaintiff’s last alleged misrepresentation is that the device is “the best alternative.”  “This is clearly an opinion and cannot be the basis for a misrepresentation claim.”  Id.  Make everything as simple as possible, but not simpler. Albert Einstein

Negligent Training:  There are FDA-training guidelines which plaintiff alleges defendant failed to adhere to.  Because Montana has adopted Restatement (Second) of Torts §324A recognizing a duty to exercise due care in rendering a service to another, “Montana law provides a parallel claim for the negligent training [plaintiff] alleges.”  Id. at *7.  But, plaintiff did not allege any facts demonstrating that defendant’s training differed from the FDA guidelines or how that deviation was a cause of her injuries.  Therefore, while the claim is not preempted, it is dismissed with leave to amend.  The same reasoning applied to plaintiff’s claims for negligent entrustment and training for hysteroscopic equipment.  This is equipment that is independent of but necessary to the implantation of the Essure device.

Negligent Distribution:  Plaintiff alleged defendant required physicians to purchase to kits per month.  But, a purchase minimum would only pose a danger if “the device itself was defective, which would require a showing the FDA requirements themselves were deficient.”  Id. at *9.  So that claim is preempted.  Our life is frittered away by detail. . .  Simplify, simplify.  Henry David Thoreau

Negligent Risk Management:  Plaintiff alleged defendant was required to have a risk management plan in place to deal with consumer complaints.  But, since Montana law doesn’t recognize a failure to report claim, this claim is preempted.  Id.

 Unfair Trade Practices:  This claim was premised on warranties and deceptive advertisements.  Since it is “founded on expressly or impliedly pre-empted claims,” it too was dismissed.  Id.

And we’ll leave it there because simplicity is the glory of expression.  Walt Whitman

Back in March, we discussed the Administration’s declaration of tort immunity under the “PREP Act” (42 U.S.C. §§247d-6a, et seq.) for “countermeasures” combating the COVID-19 epidemic.  Today, we’re discussing the first cast that we know of to construe this declaration.

That case is Estate of Maglioli v. Andover Subacute Rehabilitation Center I, 2020 WL 4671091 (D.N.J. Aug. 12, 2020), and it arises in the context of the removal of a couple of nursing home negligence actions to federal court.

The defendants, a nursing home operator and certain of its employees, offered two bases for federal jurisdiction:  (1) complete preemption under the aforementioned PREP Act, and (2) federal officer jurisdiction under 28 U.S.C. §1442(a)(1), a topic we recently addressed hereMagioli, 2020 WL 4671091, at *2.  We are mostly interested in the first ground, which involves a lot of so-far legally uncharted territory.

Our readers have probably already figured out the substance of the allegations in Maglioli – defendants allegedly negligent in not preventing death/injury caused by COVID-19 at the facility in question.  Plaintiffs, who filed in state court and wished to remain there, “d[id] not in so many words set forth a federal-law cause of action.”  Id.  Defendants, however, alleged that the sweeping immunity conferred by the March, 2020 PREP Act declaration created federal jurisdiction by completely preempting the plaintiffs’ state-law negligence claims:

Defendants removed the actions on the basis that the PREP Act “provides liability protections for pandemic and epidemic products and security countermeasures,” including “respiratory protective devices.”  Defendants state that they are “covered persons” under the PREP Act and that such “a ‘covered person’ shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure’ during a health emergency.”

Id. (citing 42 U.S.C. § 247d–6d(a)(1)).  Maglioli recognized that the HHS declarations we blogged about before set the scope of immunity and “expand[ed]” the definition of “covered countermeasure” to include:

any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.

2020 WL 4671091, at *4 (quoting 85 Fed. Reg. 15,198, 15,202 (HHS March 17, 2020)).  “[F]urther expan[sion]” followed to:

Create[] a new category of covered countermeasures eligible for liability immunity under the PREP Act, namely, respiratory protective devices approved by . . . NIOSH . . . that the Secretary determines to be a priority for use during a public health emergency

Id.  See 42 U.S.C. §247d-6d(i)(1)(D) (“a respiratory protective device that is approved by the National Institute for Occupational Safety and Health”).

Maglioli also recognized the PREP Act’s express preemption clause:

During the effective period of a declaration . . . or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that −

(A) is different from, or is in conflict with, any requirement applicable under this section; and

(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the [FDCA].

2020 WL 4671091, at *7 (quoting 42 U.S.C. §247d-6d(b)(8)) (emphasis added).

Maglioli discerned two limits to PREP Act preemption.  First, it held that preempted conduct “is bound to the ‘physical provision of the countermeasures to recipients,” or “relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.’”  Id. at *6 (quoting HHS “supplemental information”).  Second, Maglioli erroneously equated the express preemption with “conflict preemption,” id., which is an implied preemption concept (albeit included in PREP Act’s express preemption language), and asserted that the PREP Act’s preemption clause “does not by itself mandate a federal forum or completely preempt all claims arising out of the adequacy, or not, of the medical care afforded by these defendants when infected with the COVID-19 virus.”  Id. at *7.  At best that second assertion is incomplete.

Here’s what’s wrong with Maglioli.  First, while the PREP Act’s preemption clause did not “mandate a federal forum,” the decision inexplicably failed to discuss 42 U.S.C. §247d-6e(a), which definitely does just that.  This section of the PREP Act expressly establishes an alternative federal compensation program where, as with COVID-19, a PREP Act declaration has issued:

Upon the issuance by the Secretary of a declaration . . . there is hereby established in the Treasury an emergency fund designated as the “Covered Countermeasure Process Fund” for purposes of providing timely, uniform, and adequate compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure pursuant to such declaration.

Id.  This is important for “complete preemption” purposes, since the availability of an alternative forum is usually required for this form of jurisdiction to exist.  See Aetna Health Inc. v. Davila, 542 U.S. 200, 208-09 (2004) (because ERISA contains an “integrated enforcement mechanism,” it has “extraordinary pre-emptive power” and “converts state causes of action into federal ones for purposes of determining the propriety of removal”); Beneficial National Bank v. Anderson, 539 U.S. 1, 10-11 (2003) (statute “providing an exclusive federal cause of action” contains “the requisite pre-emptive force to provide removal jurisdiction”); Goepel v. National Postal Mail Handlers Union, 36 F.3d 306, 311 (3d Cir. 1994) (“we have held that the complete preemption doctrine applies only if the statute relied upon by the defendant as preemptive contains civil enforcement provisions within the scope of which the plaintiff’s state claim falls”).

Second, Maglioli is mistaken when it reads the express preemption clause (quoted above) as “at most” “restrict[ing] any state from passing a law that conflicts with the federal government’s requirements for . . . of covered countermeasures.”  2020 WL 4671091, at *9.  That’s just wrong.  The battle over what “requirement” means in an express preemption clause ended years ago.  “Requirement” also includes state tort law:

In interpreting two other statutes we have likewise held that a provision pre-empting state “requirements” pre-empted common-law duties. . . .  Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments.  Absent other indication, reference to a State’s “requirements” includes its common-law duties.

Riegel v. Medtronic, Inc., 552 U.S. 312, 324 (2008) (citations omitted).  That ship has definitively sailed.

Other aspects of Maglioli fall in murkier areas.  The plaintiffs in Maglioli argued that “Defendants d[id] not fall within the scope of the PREP Act,” because their claims were “not directed against Defendants’ role in the manufacturing, distribution, administration, or use of a covered countermeasure.”  2020 WL 4671091, at *8 (citation omitted).  The court agreed, tying the scope of preemption to the defendant having actually used a PREP Act “countermeasure”:

Nothing in the language of the Act suggests that it was intended to more broadly displace state-law causes of action for, e.g., malpractice or substandard care − even if proper care possibly would have entailed administration of such countermeasures.

Id.

So Maglioli drew the jurisdictional line between cases where a PREP Act countermeasure was actually used – which by implication would be completely preempted and subject to removal to federal court – but would allow a state-court plaintiff to base a negligence claim on a defendant’s failure to employ such a countermeasure.  “[T]he PREP Act . . . is designed to protect those who employ countermeasures, not those who decline to employ them.”  Id. at *9.  “[A]cts such as social distancing, quarantining, lockdowns, and [the like] . . . are not covered ‘countermeasures’ under the PREP Act at all.”  Id. at *10 (citation and quotation marks omitted).  Cf. §247d-6e(a) (compensation program covers “injuries directly caused by the administration or use of a covered countermeasure”).  We don’t know whether this is the right line or not (“we’re more used to “different from or in addition to” preemption language, under which such claims would be preempted), but as Maglioli appears to be the first decision called upon to draw that line, it is significant.

Maglioli also rejects an “unstated premise” – which may mean a “straw man” − that the PREP Act creates “field preemption.”  2020 WL 4671091, at *8.  Field preemption is very rare, and since the express preemption clause doesn’t flatly state that “all is preempted,” its existence implies that something must be left that is outside of its scope.  So we question whether the defendants were ever actually arguing field preemption.  In any event, Maglioli rejected complete preemption by field preemption as a basis for subject matter jurisdiction:

[T]he PREP Act . . . does not “occupy the field” of negligence or malpractice claims, even if that negligence or malpractice happens to relate to the COVID-19 illness.  Its effect is confined, for example, to the administration of certain countermeasures, and requires case by case analysis.  In short, I think the PREP Act limits the range of what the plaintiff can sue for − whether in state or federal court − but does not rule out all such claims.  Plaintiffs, in pursuing their claims in state court, may find that their claims are confined by those limitations.  I believe, however, that the Act still leaves room for ordinary claims of negligent or substandard care.

Id. at *9.  A broader reading would, as Maglioli observed, id. at *11, effectively federalize all COVID-19-related litigation of this sort (nursing home negligence).

As indicated above, the defendants in Maglioli asserted a second jurisdictional basis for removal −  that they were “acting under” the supervision of the United States, the litigation “related to” their actions “under color” of that federal authority, and they stated a “colorable federal defense.”  2020 WL 4671091, at *3.  This second basis is less novel than the heretofore uninterpreted PREP Act.  We do point out, however, that Maglioli’s restrictive view of federal officer removal is distinctly at odds with the recent Fifth Circuit decision in Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286 (5th Cir. 2020) (en banc), discussed here, which pointed out that the Supreme Court “has consistently urged courts to avoid ‘a narrow, grudging interpretation of §1442(a)(1).’”  Id. at 290 (quoting Willingham v. Morgan, 395 U.S. 402, 407 (1969)).  In particular, Maglioli’s construction of this form of jurisdiction as requiring acts “performed pursuant to an officer’s direct orders or comprehensive and detailed regulations,” 2020 WL 4671091, at *13, is based entirely on cases that predate the 2011 congressional amendment broadening the statute that convinced the en banc Fifth Circuit to abandon more restrictive precedent in Latiolais.

*     *     *     *

Note:  since this post was originally drafted, we have become aware of a second case (rather, set of cases) dealing with the same issue.  Seee.g.Baskin v. Big Blue Healthcare, Inc., 2020 WL 4815074, at *6 (D. Kan. Aug. 19, 2020) (reaching similar “conclusion that the PREP Act applies to action, not inaction”) (one of eleven legally identical decisions).

We begin with an update on the “visiting dogs’ health crisis.”  All medications are finished, special diets are a thing of the past, and (dare we say it out loud) all canine digestive tracts seem peaceful.   The chubby Pomeranian was relieved of about four inches of hair today at the hands of a saintly groomer who is undeterred by the teeth of irascible little dogs. We report, with great hope, that the Drug and Device Law Rock Climber plans to retrieve her dogs this weekend if she is COVID-negative after her plane trip to Wyoming.  (Cue “What I Did for Love,” the all-purpose anthem from “A Chorus Line.”)

Speaking of things we love, we report today on a wonderful addition to our “comment k” series.  In Keen v. C.R. Bard, Inc., ___ F. Supp. ___, 2020 WL 4873634 (E.D. Pa. Aug. 19, 2020), the plaintiff was implanted with the defendant’s inferior vena cava (“IVC”) filter.  The filter fractured, and the plaintiff underwent revision surgeries to remove fractured portions of the filter.  He asserted the usual product liability claims, including negligence, negligent misrepresentation, implied warranty, and two strict liability claims (design defect and manufacturing defect).  And it is the strict liability claims on which we focus today.

Regular blog readers (and those of you who aren’t will have no idea from whence came the dog update) are aware that we have been following, with great interest, a chess match in Pennsylvania’s federal district courts.  Over the past year or so, as we reported here and here and here and here, decisions have proliferated on both sides of the “issue” of whether comment k to Section 402(A)  of the Restatement (Second) of Torts bars strict liability claims against manufacturers of prescription medical devices.

As we have made clear, we believe this is not an “issue” at all.  It is undisputed, under Pennsylvania law, that comment k’s “unavoidably unsafe products” exception bars strict liability claims against manufacturers of prescription drugs.  And while the Pennsylvania Supreme Court has never explicitly held that the bar also protects manufacturers of prescription medical devices, the Superior Court did (in Creazzo), dozens of federal decisions followed suit, and everyone with common sense understood that there was no principled distinction to be made.

But this didn’t stop the plaintiff bar from mis-citing new decisions – Lance and Tincher – to pique the interest of federal judges entertaining strict liability claims.  The result was a handful of good, sensible decisions and at least an equal number of very bad holdings disregarding decades of federal and state jurisprudence and overstepping anything Erie ever contemplated.

Against that backdrop, the defendant in Keen moved to dismiss the plaintiff’s strict liability claims, arguing that comment k barred the claims.  The plaintiff countered with the now-familiar argument that comment k does not apply across the board in medical device cases – that it applies only on a case-by-case basis after a determination that the device is “unavoidably unsafe.”  In a decision resoundingly in the “good and sensible” camp, Judge Gene Pratter of the Eastern District of Pennsylvania rejected the plaintiff’s argument.

Judge Pratter began with the usual retrospective – Hahn, Incollingo, Creazzo.   She moved on to cite the decision of another Eastern District judge in Rosenberg v. C.R. Bard, Inc., 387 F. Supp. 3d 572 (E.D. Pa. 2019), for the proposition that comment k “focuses on products [that] cannot be legally sold except to physicians or with a physician’s prescription” and that there is “no meaningful distinction” that can be “drawn between prescription drugs and medical devices.”  Keen, 2020 WL 4873634 at *6 (citation omitted).   She continued,

Therefore, is not surprising that a subcommittee note to the Pennsylvania Bar Institute’s Suggested Standard Civil Jury Instructions notes in regard to the duty to warn in the prescription drug and medical device context that ‘Pennsylvania courts have declined to apply strict liability in cases involving prescription drugs and medical devices.’  It is not surprising that many district courts applying Pennsylvania law have similarly predicted that the Pennsylvania Supreme Court would likely extend its bar of strict liability of prescription drug claims to prescription medical device claims.

Id. (emphasis in original, citation omitted).  For more on those suggested jury instructions, see here.  Judge Pratter went on to reject the plaintiff’s reliance on Beard v. Johnson & Johnson, Inc. 41 A.3d 823 (Pa. 2012), acknowledging that Beard permitted strict liability claims against the manufacturer of a surgical stapling tool but emphasizing that “a surgeon’s tool is distinguishable from a medical device implanted in the body only upon obtaining a physician’s prescription.”  Id. at *7 (citation omitted).   Finally, she rejected the plaintiff’s argument that, even if comment k barred the design defect claim, it did not bar the manufacturing defect claim, holding, “[T]he Court disagrees with Mr. Keen that the Pennsylvania Supreme Court would deviate from its otherwise uniform application of comment k in order to permit strict liability claims based on manufacturing defect theory.”  Id.   Judge Pratter concluded:

In sum the Court predicts that the Pennsylvania Supreme Court would apply comment k to all of Mr. Keen’s strict liability claims.  Therefore, the Court grants [the defendant] summary judgment in its favor regarding Mr. Keen’s strict liability claims alleging defects in design, manufacturing, and failure-to-warn.

Id. at *8.

This is textbook stuff, a primer on the proper “predictive” role of a federal district court sitting in diversity and on the use of case precedent and authoritative commentary in making the required prediction.  We love this part of the decision.  And we think you get the idea by now, so we likely will not report on every similar decision, though we will keep you apprised of anything noteworthy and will check in occasionally with a report on the “state of the split.”  This is a very big deal for our medical device clients, and we wish for judges who follow Judge Pratter’s template and arrive at equally correct decisions.

We are heading out for a twilight walk with too many dogs.  Our neighbors are sure that we’ve lost our mind (assuming they needed convincing), but we appreciate the distraction in these still-crazy times.  Stay safe out there.

 

To us – and we suspect to most of the exceptional public servants employed by the FDA – Sunday, August 23, 2020 will be a day they would rather forget.  On that day the Agency issued an “emergency use authorization” (“EUA”) for what is known as “convalescent plasma” for the treatment of COVID-19, notwithstanding a relative dearth of scientific support for the effectiveness of this treatment for this indication.  Beyond the plasma treatment itself, which at least doesn’t seem dangerous, the FDA’s action – and particularly its gross overstatement of the treatment’s effectiveness – stoked fears that this action was driven by overt political pressure.  That has frightening implications.  Is this the first step down the path to Lysenkoism for the Agency?

In the not-too-distant future, when the FDA is called upon to evaluate the safety and effectiveness of an actual COVID-19 vaccine, will the Agency follow the Russian example?  That could cause a true disaster, should a rushed, unproven vaccine prove ineffective, while at the same time having crowded out more efficacious competitors, and poisoned public opinion against COVID-19 vaccination generally.

We note that the FDA’s apparent scientific surrender came one day after the president’s now notorious tweet that claimed the Agency harbored unidentified “deep state” personnel that were delaying agency action to cause “political” damage.  Just about everyone outside of the president’s base finds that accusation “baseless” or worse.

First, a little background.  Despite the hype (where have we seen this before?), convalescent plasma is neither a cure nor a breakthrough.  It’s simply blood plasma (the not-red part of blood) donated by people who have recovered from COVID-19.  Such donations (for other purposes) have been routine for decades, and it is a “longstanding treatment strategy for infectious diseases that involve the respiratory system.”  The FDA has provided some background:

Passive antibody therapy, including convalescent plasma, has been proposed or used to treat a wide variety of infectious diseases for more than a century, including several respiratory viral illnesses such as influenza, Respiratory Syncytial Virus (RSV), Severe Acute Respiratory Syndrome (SARS), and Middle East Respiratory Syndrome (MERS). . . .  Passive immune therapy . . . is thought to be most effective when administered prophylactically. . . .  However, well-controlled studies in this field are rare.

Clinical Memorandum,” concerning “COVID-19 Convalescent Plasma,” at p. 3 (amended Aug. 23, 2020) (footnotes omitted).  In this case, the plasma contains antibodies that the once-infected donors’ immune systems created to combat COVID-19.

Even as to COVID-19, this treatment has been around for (relatively) some time.  Tens of thousands of people infected with COVID-19 have already been treated with it, but not in any scientifically controlled fashion.  This extensive use is why, unlike the previously promoted off-label use of hydroxychloroquine, the plasma therapy does appear to be safe.  High risks would already have been identified.  But the FDA’s 8/23 emergency use authorization does not cite to controlled studies, or to any COVID-19-related study of any sort, that compare this treatment to placebo.

The FDA’s more comprehensive memorandum mentions a couple of more general controlled studies, but dismisses favorable results as “low quality” and potentially biased:

A systematic review of passive antibody therapy for SARS coronavirus (SARS-CoV-1) and severe influenza found a trend towards reduction in mortality, but noted that studies were commonly of low or very low quality, lacked control groups, and were at risk of bias.

Clinical Memorandum, at 6 (footnote omitted); id. at 7 (describing randomized studies as “underpowered”).  That no reliable studies exist is not surprising, since use of convalescent plasma during the pandemic has been therapeutic – to try to treat the damn disease.  But the FDA’s sudden willingness to authorize use in an admitted data vacuum is troubling, particularly given the timing.

The Mayo Clinic, which has been coordinating existing efforts, and also studying the statistics, currently concludes only:

The relationships between reduced mortality and both earlier time to transfusion and higher antibody levels provide signatures of efficacy for convalescent plasma in the treatment of hospitalized COVID-19 patients.  This information may be informative for the treatment of COVID-19 and design of randomized clinical trials involving convalescent plasma.

Joyner, et al., “Effect of Convalescent Plasma on Mortality among Hospitalized Patients with COVID-19:  Initial Three-Month Experience,” at 4 (Aug. 12, 2020) (non-peer-reviewed), available here.

The FDA concluded that this Mayo Clinic data lacked both “precise performance characteristics” and “gold-standard methodology,” which “were not available at the time of this review.”  Clinical Memorandum, at p.10.  As to the effectiveness of convalescent plasma to treat COVID-19, the FDA’s evaluator concluded:

Considering the totality of the scientific evidence summarized above, I agree that current data support the conclusion that CCP [convalescent plasma] to treat hospitalized patients with COVID-19 meets the “may be effective” criteria for issuance of an EUA.  Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of CCP efficacy and to determine the optimal product attributes and the appropriate patient populations for its use.

Clinical Memorandum, at p.11.

However, that caution-filled go-ahead was nowhere in evidence at the 8/23 press conference.  Rather, everyone who spoke – including the FDA commissioner himself − grossly overstated the effectiveness of convalescent plasma by claiming that it reduced the COVID-19 death rate by 35%.  That simply ain’t so, and belatedly, days after the damaging misperception was created, the commissioner admitted it.  Given the number of people who have already been treated with convalescent plasma, something as dramatic as a 35% overall decrease in mortality would have stuck out like a sore thumb and would have been detected long ago by even rudimentary statistical analysis.  Instead conference participants inflated what was merely a limited relative risk differential found when use of plasma was compared to no equivalent treatment.  Specifically, we think that the 35% was cherry-picked from the Mayo Clinic data, most likely from this aspect of Mayo’s analysis:

[T]here is a consistent signal of a protective effect of the high antibody levels across the strata.  The pooled, or common, relative risk for 7-day and 30-day mortality were 0.65 (0.47 to 0.92) and 0.77 (0.63 to 0.94).

Effect of Convalescent Plasma, at 12.  Thirty-five percent is the difference between the 7-day mortality relative risk and one (1 – 0.65).  But that was only one (and the most optimistic) “alternative analytical approach” in the Mayo Clinic non-peer-reviewed data, and was limited to:  (1) higher versus lower doses in (2) persons who were not that severely affected by COVID-19, and (3) who received the transfusion within three days of diagnosis.  Id. at 12-13.

The FDA thus engaged in nationally televised statistical exaggeration that, if attempted by any of our clients, would have resulted in a warning letter or worse.  The Agency should be ashamed of its performance, particularly given the overt political pressure immediately preceding the action, the magnitude of the misstatement, and the Agency’s significant delay in issuing a correction.  The scientifically-based verdict remains:

Randomized controlled trials are required to show definitive evidence of safety and efficacy and to determine the optimal product attributes and appropriate patient populations for the use of COVID-19 Convalescent Plasma.

Clinical Memorandum, at p.14.

This is hardly the first time there has been evidence of the FDA making regulatory decisions based on political, rather than medical, considerations.  This Blog has chronicled the fraught origin of the now-dead FDAfinal rule” that sought to change drug reporting requirements to eliminate preemption as applied to generic drugs.  That was a blatant attempt to mollify the plaintiffs’ bar in accordance with the political leanings of the prior administration – and we did not hesitate to call it such:

[F]rom our perspective, anyway, it appears[] the FDA suffered what is sometimes called “agency capture” by pro-plaintiff elements. . . .  [T]he FDA did what the other side wanted and issued a proposal to change its regulations designed to thwart preemption in product liability litigation.

What happened the other day, however, is much worse.  While the FDA “final rule” sought to jigger agency processes to help the plaintiffs’ bar thwart preemption, that was the extent of it.  That was bad enough, as we pointed out repeatedly, but the “final rule” only attempted to revise certain internal procedures to assist a politically powerful interest group then allied with that administration.  The FDA’s core mission – using science to insure the safety and effectiveness of prescription medical products – was unaffected by that unsuccessful “final rule.”

Not this time.

On August 23, 2020, the leaders of the FDA at the very least gave the appearance of jettisoning science, and did so seemingly for political reasons.  They did this, not just in the absence of sound data, but over the objections of many scientists, including Dr. Anthony Fauci, and the National Institutes of Health as a whole.  Further, the Agency did so at a politically chosen time, and in a politically charged setting.  The FDA approved, for unlimited emergency COVID-19 treatment, a substance supported by no generally accepted methodology – let alone the FDA’s longstanding “gold standard” of controlled clinical trials.

Perhaps even worse, with the FDA having let this genie out of the bottle, it will likely be impossible ever to conduct the type of statistically valid controlled trials that the FDA usually requires.  As we’ve said before (most recently here), once a treatment modality becomes the medical standard of care, blinded trials become medically unethical.  That’s a big problem with off-label uses if they, over time, achieve standard-of-care status.  It’s a bigger problem here, where the FDA itself is responsible for the hype that may well push a not-ready-for-primetime treatment prematurely towards general medical acceptance.

Maybe, in this instance, everything will turn out OK from a medical standpoint.  Notwithstanding the FDA’s EUA, convalescent plasma remains “an unapproved biological product” that is subject to restricted investigational use, as detailed here.  As we recently observed in our comment on the Russian “Sputnik V” vaccine, “[n]ot every cut corner, no matter how brazen, results in a head-on collision.”

But until now, that has never been how the FDA has done things.  We always thought of science as the FDA’s unshakable bottom line, but we’re afraid this is no longer the case, at least when the Agency is under COVID-19 political pressure.

It is an old legal adage that hard cases make bad law. One could also say that big cases make bad law, especially if by “big” we include Multi-District Litigation (MDL) cases. When a federal judge is suddenly in charge of thousands of cases, that judge will too often start thinking more like a manager than a scholar. The emphasis is on disposition of the inventory. That means settlement. Consequently, we get decisions, or often non-decisions, that are designed to foster settlement, not resolve complex legal issues in an intellectually coherent way.

But then something strange happens near the end of the life-cycle of MDLs. After the bulk of the cases are settled, there remains a “tail” of cases or about-to-be-filed cases. Those cases are holdouts. They are in the hands of plaintiff lawyers who are opportunistic and/or recalcitrant. At this point, the MDL judge gets a wee bit irked, seeing these holdouts as standing in the way of ending the MDL and giving the judge something to brag about at the next judicial conference. So what happens? All of those defense dispositive motions that earlier met with a shrug, including statute of limitations motions, suddenly start gaining attention. They even start winning. One doesn’t have to be entirely cynical to wonder why they weren’t winning much earlier in the litigation.

The vaginal mesh MDL (technically multiple MDLs – each manufacturer getting its own MDL number, but still sharing the Charleston, West Virginia courtroom with other mesh companies) has been a big one even by MDL standards. It has also produced some rulings that have left the defense bar scratching heads and contemplating other lines of work. For example, vaginal mesh MDL rulings have kept out the fact of FDA 510(k) clearance, which, contrary to the court’s opinions, really is relevant to the medical device’s safety, but have let in the raw materials Material Safety Data Sheet (MSDS) which, contrary to the court’s opinions, really is not. (There are some courts that have correctly admitted the fact of 510(k) clearance. See here and here, for example.)

But the Daubert rulings in the mesh MDL have not been entirely bad. Naturally, we defense hacks think the court let too many plaintiff expert windbags opine on things sans support, reliable methodology, or relevance, but any perusal of the court’s Daubert opinions will show that the court did the one thing that Daubert requires and that too many judges resist: it did the work. The court read the expert reports carefully, read whatever was supposed to pass for support of the opinions, and considered the competing arguments. The result was a series of opinions that let some things in and kept some things out. Again, we’d have to turn in our DRI card if we did not carp about some of these Daubert rulings. Nevertheless, by showing its work and drawing distinctions, the mesh MDL court created the sort of record that will force any appellant to sweat.

The vaginal mesh cases are now being remanded. In many of those cases, Daubert issues remain to be adjudicated. Not surprisingly, some remand courts are displeased. But they have a pattern to follow, at least mostly. The remand courts continue to pick and choose which expert opinions to wave along and which ones to block. In Arevalo v. Coloplast Corp., 2020 U.S. Dist. LEXIS 124417 (N.D. Fla. July 7, 2020), the court ruled on Daubert challenges in a case involving pelvic organ prolapse and stress urinary incontinence mesh implants. The opinion is the veritable mixed bag, granting parts and denying parts of various Daubert challenges for a long list of experts, both plaintiff and defense sides. Several of the experts are repeat players; many of us have dealt with them many times.

The Arevalo court excluded many plaintiff expert opinions, and we will summarize those exclusions. The court also let plenty of those opinions in, and also excluded some defense expert opinions. You will want to read the entire opinion before citing the case, of course. But at this point we are not in the business of broadcasting any help-aids for plaintiff lawyers. They’ll have to read the opinions for themselves – a surprisingly high barrier to entry for our learned opponents.

    Alan Garely

– Plaintiff general causation expert
His general opinion was unreliable because he did not adequately explain how the cited literature and his observations supported his opinions that the injuries associated with the prolapse product are directly attributable to the device’s reaction in vivo and defective design.

    Jimmy Mays

– Plaintiff polymer science expert
His assumption that strong oxidizing agents in the body “continually” attack the polypropylene as long as the implant remains in the body is not adequately supported. His opinion that oxidation agents deplete the antioxidative additives during the lifetime of the implant is unreliable because he did not test the defendant’s products nor rely on literature that involved such testing.
His reliance on an article he co-authored is excluded because that article’s testing was unreliable. (That’s a bit of a burn.)
His opinions on medical complications is excluded because he is not a medical doctor.
He is permitted to rely on the MSDS (the biggest takeaway from the vaginal mesh litigation might end up being the phony significance of the MSDS) but cannot use the MSDS to render toxicology opinions, as he is not a toxicologist.

    Peggy Pence

– Plaintiff regulatory and industrial standards expert
It is not clear how she was permitted to testify at all, given the MDL court’s no-FDA evidence ruling. Nevertheless, the Arevalo court permits her to say quite a bit, though there are some limits. For instance, Pence cannot testify that the defendant was “required” to do something by FDA guidance documents. And while she can explain industry standards and the need for testing generally, she cannot draw the ultimate conclusion that the defendant’s testing was inadequate.
Pence will be permitted to discuss the adequacy of the IFUs (mind you, these are IFUs cleated by the FDA), but cannot opine about informed consent.

    Bruce Rosenzweig

– Plaintiff general and specific causation
The Arevalo held that “the causes of polypropylene degradation, polymer compounding, the products of polypropylene degradation, or the toxicity of of any such degradation product are subjects that are not within his area of expertise. Despite other courts finding that Dr. Rosenzweig qualifies to opine on these topics, the Arevalo court “cannot because, by his own admission, he is not an expert in polymer science, chemistry, molecular biology, biochemistry, or toxicology.”
Further, the court was “not persuaded that Dr. Rosenzweig employed a reliable methodology in forming his general causation opinion (i.e., that polypropylene mesh degradation causes pelvic pain, vaginal pain, dyspareunia, frequent UTIs, urinary and fecal incontinence) because although articles cited by Dr. Rosenzweig conclude that polypropylene mesh degrades in vivo, the Court did not see that any explained the mechanism by which degraded mesh causes the injuries alleged by Plaintiff, nor any that offered the ultimate conclusion that degradation of the mesh can cause these injuries in humans.” That is potentially a powerful ruling because so many plaintiff urogynecological experts in the mesh litigation make the casual leap from mesh degradation (also phony, by the way) to clinical consequences.
His testimony that the product is defective because it lacks a protective sheath is excluded because it is based on speculation or mere anecdotal evidence.
Dr. Rosenzweig can discuss how the mesh has small pores, but he does not provide a basis for his opinion that the mesh is heavyweight. Moreover, his opinion that the product requires a “blind” needle passage was merely subjective and conclusory. There was no supporting data.
As is typical in mesh cases, Dr. Rosenzweig opined about the availability of safer alternative designs. Several of those opinions were excluded in Arevalo. He did not supply an adequate basis to explain why products with less polypropylene, different shapes, larger pores, etc. would be safer. His references to non-sling alternatives such as the Burch procedure and autologous (tissue) slings must be excluded because those are not alternative products,
The decision regarding Dr. Rosenzweig’s opinions on informed consent looks like classic baby-splitting. He can talk about it generally, but not specifically, since he cannot read the mind of the plaintiff or her doctor.
As usual, Dr. Rosenzweig purported to ground his ultimate specific causation opinions on a “differential diagnosis.” The Arevalo court was not snookered by this incantation. Instead, the court looked carefully at Dr. Rosenzweig’s “differential diagnosis” and concluded that so much of it was mere say-so. He did not “explain how he systematically and scientifically ruled out the other potential causes for Plaintiff’s condition, such as her rectocele, cystocele, or uterine prolapse. Even if multiple factors work together to cause the injury, the expert is still required to provide some analysis of why he concluded that, more likely than not, the product substantially contributed to the condition.”
Dr. Rosenzweig’s opinions about the insufficiency of the defendant’s testing fell short of reliability because they were based solely on his his own view of what a reasonable manufacturer should have done, rather than any objective standards.

As mentioned, there is a lot more to the Arevalo opinion. If you cite its good parts you must anticipate the possibility that you will be saddled with its bad parts. Just like the treating doctors, or like any expert who actually plays the role conscientiously, you must perform a rigorous risk-benefit analysis.

About two months ago we wrote the post Complaints Are Like Onions, They Have Layers about the need for courts to “address the viability of each claim” on a motion to dismiss.  Bayer Corporation v. Leach, 2020 WL 3118509 at *1 (Ind. S. Ct. Jun. 12, 2020).  Complaints need to be pulled apart and each cause of action and/or theory of liability needs to be examined – like they layers of an onion.  Or to continue the theme of our prior post, maybe you’re more of a Donkey than an Ogre and you prefer to draw an analogy to parfaits.  After all, “parfaits are delicious” and parfaits have layers.  We certainly aren’t going to argue otherwise.  But we think complaints are more like onions – they can stink, they can make you cry, and if left too long “they start sprouting little white heads.”  Well, not literally, but you get the idea.  Onions, ogres, complaints – they all have layers that require peeling because sometimes you find a layer or two worth tossing down the garbage disposal.

That’s what the Indiana Court of Appeals was charged with doing on remand – peeling apart the layers of plaintiffs’ complaint.  In other words, this time they actually had to rule on defendant’s preemption arguments for all causes of action.  Previously, the trial and appellate courts had ruled only that plaintiffs’ manufacturing defect claim was not preempted and therefore since one claim was viable, there was no need to determine if any others should be dismissed.  Being forced to look at each cause of action led to a mixed-result, but at least we’re left with a smaller onion this time around.

First up was negligence per se.  Plaintiffs attempted to premise liability on standards imported from the Indiana Uniform Food, Drug, and Cosmetic Act (“Indiana FDCA”).  Like so many states, the Indiana FDCA follows the FDCA.  Because the acts are parallel, claims premised on the Indiana FDCA are not independent from the FDCA making them impliedly preempted under BuckmanBayer v. Leach, 2020 WL 4811506, *5 (Ind. Ct. App. Aug. 19, 2020).

Next plaintiffs brought manufacturing and warning defect claims under the Indiana Products Liability Act (“IPLA”).  To the extent their manufacturing claims were premised on alleged violations of federal law such as that product failed to conform to performance standards or design specifications of the PMA – those are not preempted.  Id. at *5, 6.  But plaintiffs also included a manufacturing defect claim based on failure to strengthen warnings and on making false or misleading statements.  Id. at *6.   Plaintiffs claim that defendant should have proactively changed its labeling, something “that federal law permitted—but did not require.”  Id. at *7.  However, “[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted.”  Id. (citation omitted).  Therefore, all warnings based claims were preempted.

On plaintiffs’ false and misleading statements claims, defendant offered the court documents showing that the statements complained about were approved by the FDA.  The court was unwilling to look beyond the pleadings, and therefore was also unwilling to find the fraud claims based on non-warning statements were expressly preempted.  Id. at *7-8.  Adopting the reasoning of Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010), the court found plaintiffs’ manufacturing defect claim couched as “misbranding” survived implied preemption too.  Under the IPLA, a manufacturing defect exists when a product is in a “condition . . . not contemplated by reasonable persons” that was “unreasonably dangerous to the expected user.”  Id. at *8.  The court reasoned that a jury could find that failure to comply with federal regulations regarding misbranding could create such a defect.  Because the claim is grounded in state law and does not conflict with federal law, there is no preemption.  Id. at *9.

Under the IPLA, Indiana recognizes claims for inadequate warnings and claims for inadequate instructions.  To succeed on an inadequate warning claim, a jury would have to find that “the manufacturer should have used different labeling or packaging.”  Id. at *10.  But, because federal law required the manufacturer use the pre-market approved labeling/packaging – that claim is expressly preempted.  Id.  But the court decided it didn’t need to peel this whole layer off.  Plaintiffs had included allegations about failure to report adverse events to the FDA in their warnings claim.  The court found those allegations to be potentially actionable as manufacturing defect claims because violations of reporting requirements could render a product adulterated or misbranded.  Claims the court allowed to continue under BauschId. at *11.

The IPLA also recognizes a failure to instruct claim.  The PMA for the product included a “duty to train physicians” that plaintiffs allege defendant violated.  Id.  Plaintiffs also alleged that defendant voluntarily undertook training duties beyond those imposed by the FDA and that defendant performed those duties negligently.  Id. As with the non-warning statements, the court was unwilling to review documents outside the pleadings that defendant offered to demonstrate the actual scope of the FDA’s training requirements.  Assuming plaintiffs’ allegations accurately reflected the FDA’s training requirements, plaintiffs’ failure to instruct claim was not preempted because it was a state law claim premised on a violation of federal law.  Id.  As to the voluntarily provided additional training (Good Samaritan theory), the court concluded that those claims either “do not implicate the explicit preemptive text of the MDA” because voluntary undertaking was “extra-regulatory” or defendant violated federal law when it undertook training not  identified in the PMA because any change that affects safety or effectiveness requires pre-approval.  Id. at *12.

Definitely a mixed-result, but we’d rather have a smaller, more-manageable onion as opposed to one that’s a “virtual planetoid that has its own weather system.”  (had to bring Mike Myers full circle).

April Zambelli-Weiner is an epidemiologist (meaning she’s not an M.D.), on the plaintiffs’ side, who claims expertise in a wide variety of areas.  In addition to the Zofran (birth defect) litigation that prompted this (and a prior) post, her name pops up in litigation over leukemia, Walsh v. BASF Corp., ___ A.3d ___, 2020 WL 4135151, at *12 (Pa. July 21, 2020) (“no ruling with respect to whether [her] failure to opine on whether . . . specific products may cause leukemia precludes her use as an expert”); inflammatory bowel disease, In re Accutane Litig., 2020 WL 260901, at *8 (N.J. Super. App. Div. Jan. 17, 2020) (“her analysis did not conform to the scientific methodology”), certif. denied, 2020 WL 2555213 (N.J. May 12, 2020); strokes, Galinis v. Bayer Corp., 2019 WL 2716480, at *10 (N.D. Cal. June 28, 2019) (testified that “studies funded by or otherwise associated with” the defendant were less “reliable than an “FDA-funded study”); and uterine perforation, In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 482-88 (S.D.N.Y. 2016) (opinions “outside the scope of her expertise” and “not based on a sound methodology”).

We’ve already described the underlying dispute about her actions in our “Stupid Expert Tricks” post, so we won’t repeat that here.  Suffice it to say that some of the testimony she offered caused her own lawyer to “file[] an emergency motion to withdraw his appearance, notifying the Court that he had learned that ‘factual representations’ made in her affidavit were ‘inaccurate.’”  In re Zofran (Ondansetron) Products Liability Litigation, 392 F. Supp.3d 179, 183 (D. Mass. 2019) (“Zofran I”).  As we already blogged, Zofran I granted the defendant’s motion to compel additional discovery into the unusual plaintiff-side funding (to the tune of over $200,000) of a study that Zambelli-Weiner conducted while a plaintiffs’ “consultant” to support the plaintiffs’ allegations in the Zofran MDL litigation.

In the prior post, just about every one of the “stupid expert tricks” we recounted was accompanied by prolonged attempts to thwart discovery into the conduct of the experts at issue.  The Zofran MDL is no different.  After being compelled to turn over documents detailing how her study was conducted in collaboration with plaintiffs’ counsel from the outset, Zambelli-Weiner invalidly claimed that documents she thereby produced were “confidential” when they really weren’t.  Her further attempts at preventing public disclosure were rejected in In re Zofran (Ondansetron) Products Liability Litigation, 2020 WL 1550563 (D. Mass. April 1, 2020) (“Zofran II”).  Perhaps the MDL judge has a sense of humor – issuing this opinion on April Fools’ Day.

Four documents were “de-designated” in Zofran II.  They are now public, and we have them – so anyone can read them.  Here is the MDL court’s brief description of the procedural background:

April Zambelli-Weiner . . . is the co-author of an epidemiological study that plaintiffs cite as evidence that Zofran causes birth defects.  At the time she conducted the study, she was a paid consultant to plaintiffs’ counsel.  The study itself was funded by plaintiffs’ counsel in the amount of $210,000.  Dr. Zambelli-Weiner also participated, along with plaintiffs’ counsel, on a panel at a conference in Las Vegas concerning this litigation.

2020 WL 1550563, at *1.  Here are the documents, as described in Zofran II:

(1) a Zofran study protocol prepared by Dr. Zambelli-Weiner; (2) unpublished analyses that compared the birth defects risks associated with Zofran to those with other anti-emetic medications; (3) a draft of Dr. Zambelli-Weiner’s study prepared for submission to the New England Journal of Medicine; and (4) a “Causation Briefing Document” prepared for plaintiffs’ counsel by Dr. Zambelli-Weiner.

Id. (record citations omitted) (note: the Zofran II opinion numbers these documents differently from the exhibit numbers accompanying our versions).

“[N]one of the documents at issue are of the type ordinarily considered confidential,” id. at *2, so Zambelli-Weiner’s arguments ultimately fell on deaf ears.  As for the study protocol, her “research appears to be unrelated to any proprietary or business enterprise of any kind, except to the extent she is acting in her capacity as a paid consultant for plaintiffs’ counsel.”  Id.  We think that’s precisely right.  Zambelli-Weiner’s “enterprise” was to include junk science in the medical literature at the highest level – in the New England Journal of Medicine.  Id. at *3.  Assuming that to be the business justification for the confidentiality claim, it failed:

[Zambelli-Weiner’s] misrepresentations to the Court concerning the nature of that relationship at the very least diminish whatever discovery protections might otherwise apply.

Id. at *2.  Any resemblence to “future research” was coincidental at best.  Id. (Zambelli-Weiner’s future research claims “bear[] little resemblance” to the document in question).  Indeed, the study protocol specified that Zofran would be compared to other antiemetics, but that didn’t happen – we explain why in just a bit.  See Page 1 at “exposure definition.”

To us the most interesting point in the study protocol was the confirmation on page 2 that the drug “Diclegis” “currently is the only FDA-approved treatment for nausea and vomiting due to pregnancy.”  That drug used to be called “Bendectin,” and it “was safe, but discontinued . . . in the face of prohibitive insurance and legal costs.”  For years, we worked on Bendectin litigation – it was always based on junk science (Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), was a Bendectin case).  It’s gratifying to have a plaintiffs’ expert, who is trying to do the same to Zofran, being compelled to make that admission public.

Document number two consists mainly of “the unpublished analyses comparing Zofran’s birth-defect risks to those of other anti-emetic medications.”  Zofran II, 2020 WL 1550563, at *2.  Zambelli-Weiner tried her best to keep these numbers under wraps, even deflecting scientific inquiry after her article was published (not in NEJM, as she hoped, but in Reproductive Toxicology, a less prestigious journal):

[T]he Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency specifically asked Dr. Zambelli-Weiner whether she had performed such analyses [of other antiemetics].  In her response to PRAC, she did not reveal that these unpublished analyses existed.  Two months later, PRAC recommended a change to Zofran’s label, relying in part on her study.

Id. at *3 (record citations omitted).  Particularly given the result of this concealment, it is a good thing that this tangled web has become public.

Dr. Zambelli-Weiner herself has stated that information comparing the risk of birth defects from ingesting Zofran to that of other antiemetic medications, such as that contained in this document, is the type of important public-health information that ordinarily should be shared.

Id. (record citations omitted).

Further, based on our own review, we invite those with a statistical bent to look at the charts of relative risk and confidence intervals on pages 5 and 6 of this document.  Most of the relative risks are below one, all are below two (analogous to “more likely than not”), and the higher purported risks tend to have wider confidence intervals – indicative of smaller sample size.  The farthest right column (Exposure 4) compares Zofran to the other antiemetics − all the relative risks are either at or below 1.00, with two of them showing Zofram having a statistically significant decreased risk.  That, we think, is why none of the head-to-head product comparisons saw the light of day in Zambelli-Weiner’s published article.  In light of all this hidden data, as the MDL court stated, “[t]he unpublished analyses that compare the risk of ingesting Zofran to the risk of ingesting other anti-emetic medications thus seem to be potentially material omissions from her published study.”  Id.

Document number three (which our copy has as “Exhibit 4”) is a preliminary draft of the Zambelli-Weiner study eventually published in the Reproductive Toxicology.  It’s long and we don’t have the inclination to put it side-by-side with the final study and run a fine-toothed comb comparison – but we know who will.  As for confidentiality, Zambelli-Weiner “does not explain how any differences between this draft and the study as it was later published could constitute proprietary business information, or describe any actual prejudice that might result from its disclosure.”  Zofran II, 2020 WL 1550563, at *3.

The final document was a memo from Zambelli-Weiner to plaintiffs’ counsel in the Zofran MDL from early 2015.  The opinion describes it as “a research brief prepared for plaintiffs’ counsel by Dr. Zambelli-Weiner . . . pursuant to a consulting arrangement with the law firm of Grant & Eisenhofer, P.A., which is counsel to plaintiffs in this matter.”  Id.  As such, it was “plausibly proprietary.”  Id.  However, it proposed exactly the type of study that counsel subsequently funded and Zambelli-Weaver authored:

Nested case-control study of administrative claims database to contribute US-based data with the power to examine specific cardiac birth defects

Zambelli-Weaver memo, at “Additional Avenues for Inquiry” (unnumbered page 11).  “[S]cientists and regulatory authorities evaluating” Zambelli-Weiner’s published article:

would likely consider it material that four years before the study’s publication, and as part of a paid consulting arrangement with plaintiffs’ counsel, she proposed conducting a similar study.

Zofran II, 2020 WL 1550563, at *3.  While Zambelli-Weiner argued that “her financial relationship with plaintiffs’ counsel was sufficiently disclosed,” Zofran II took a more jaundiced view:

[Zambelli-Weiner’s] statement was only one sentence long, and indicated only that her organization had received funds from plaintiffs’ counsel.  It did not state or suggest that Dr. Zambelli-Weiner had consulted with counsel as to the nature of the study itself, or provide any detail about the extent of that relationship.  This document sheds additional light on that relationship and therefore its disclosure will also be permitted.

Id. (record citation omitted).

We are shocked, shocked to find that plaintiffs’ experts think they are entitled to act in this fashion, and then prevent discovery of those very actions.  Indeed, we find it highly ironic that Zambelli-Weiner would purport to pontificate on the “reliability” of research “associated with” a defendant, given her own conflicts of interest just described.  Galinis, 2019 WL 2716480, at *10.  We can only wonder how many times the other side has gotten away with similar shenanigans in other mass torts.

Sometimes we write on issues for peculiar reasons.  Today, for example, a case on a certain topic caught our eye because of its catchy name:  Clark v. Perfect Bar.  So many questions arise from this concise, yet provocative tag.  Did the owner of the 100-year-old brand Clark Bar get sideways with a modern upstart claiming to make the “perfect” bar.  Is Perfect Bar the name of a watering hole with an astounding selection of single malt Scotch, and if so, where might we find this “perfect bar”?  Did the case relate in any way to the post we wrote more than six years ago on granola bars, energy bars, fruit bars, protein bars, fiber bars, nut bars, candy bars, and “meal replacement” bars?

If you read Clark v. Perfect Bar and thought “food,” you are on the right track, and so is the recent Ninth Circuit opinion holding that federal food labeling laws preempt Mr. Clark’s claims against the maker of protein bars.  See Clark v. Perfect Bar, LLC, No. 19-15042, 2020 WL 4596823 (9th Cir. Aug. 11, 2020).  The plaintiffs filed a class action alleging that the bars’ labeling led them to believe the bars were “healthy,” when in fact the bars were “unhealthy” because of added sugar.  Id. at *1.  You start to get the picture.  This is another food class action brought under California’s permissive consumer statutes alleging that misleading labeling duped the plaintiffs (and others) into purchasing food that they otherwise would not have purchased.

There are usually two problems with these kinds of all-too-common lawsuits.  First, federal law requires uniform nutritional disclosures for food on its labeling, which makes it difficult for plaintiffs to prove that they have standing to sue or that food labeling is misleading in any material way.  The labeling for the protein bar at issue surely disclosed its ingredients and nutritional information, including the peanut butter flavor bar with its 19 grams of sugar—clearly disclosed right there on the label.

Second, federal statutes mandating uniform nutritional labeling can and should preempt attempts to regulate food labeling through state-law litigation.  The Nutritional Labeling and Education Act (“NLEA”) includes an express preemption provision under which the NLEA preempts all state claims that “directly or indirectly establish any requirement for the labeling of food that is not identical to the federal requirements.”  Clark, at *1.  This is a particularly strong express preemption clause:  Not only does it preempt any state-law requirement that is “not identical to” federal requirements, but it does so whether the state-law requirement is established “directly or indirectly.”

In Clark, the plaintiffs cleared the first hurdle, but the bar was low under California’s statutes.  They met the standing requirement merely by alleging that the label was misleading and that they “would not have bought the product but for the misrepresentation.”  Id.

The case faltered on preemption.  The plaintiffs based their claims on the allegation that the product labeling made an improper health claim because of added sugar.  However, the NLEA and its accompanying regulations say nothing about health claims based on sugar, i.e., they “are silent on whether sugar levels preclude a product from making health claims.”  Id.  As a result, “allowing a claim based on misleading sugar level content would ‘indirectly establish’ a sugar labeling requirement ‘that is not identical to the federal requirements.’”  Id.  Dismissal affirmed.

We are aware that express preemption rarely applies in the prescription drug context.  We are also aware that the express preemption provision that applies to many medical devices is worded slightly different (“different from or in addition to” federal requirements) and is also subject to the unsupportable and poorly understood “parallel claim” exception.  Regardless, this is another case that highlights the incongruence of regulating drug and device warnings simultaneously through FDA regulation on the one hand and through civil litigation on the other.  We have long favored a high regulation/low litigation regime that provides for greater consistency and predictability, and Clark is a good example.

By the way, we wondered whether Clark Bars still exist, and we were surprised to learn that they were reintroduced to market earlier this year after a two-year hiatus.  Good news for fans of delicious peanut butter and chocolate crunchiness.  You can review the ingredients and nutritional facts here.