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Are protective orders worth the paper they are written on?  We have heard cynical attorneys pose that question, usually in a rhetorical fashion.  But our view has always been that protective orders—which we define here as court orders entered to protect against the disclosure of confidential information—are important and ought to be followed.  This view will come as no surprise to our loyal readers, who know us to be a defense-side blog; and defendants in drug and device litigation are usually (always?) more interested in protecting confidentiality than the other side.  Even when individual plaintiffs do produce confidential information, such as medical or employment records, they often produce that information without protection or even file it openly in the public record.

So yes, we believe protective orders are worth the paper they are written on, and from time to time courts give these orders substantial teeth.  Take for example a recent order from the Northern District of California, where the plaintiffs’ attorney played fast and loose with the defendant’s confidential documents and paid a price—literally.

The order in Holley v. Gilead Sciences, Inc., No. 18-cv-06972, 2021 WL 940594 (N.D. Cal. Mar. 12, 2021), actually covered two significant transgressions by the plaintiffs’ counsel.  First, counsel’s advertising falsely claimed that the defendant did not warn regarding the subject drugs’ side effects, falsely stated that the FDA approved the drug eight years after it actually did, and misleadingly implied that cash settlements were available.  Id.  Counsel represented that they had taken down the false advertising and hired an experienced lawyer to supervise marketing, but that was not sufficient.  Because they did not change their advertising until after being asked to—“sometimes repeatedly”—by the defendant, the district court ordered counsel to produce copies of all advertisements related to the case.  Id.  Not so bad in our view, given the gravity of the conduct (spreading falsehoods).  The district did punctuate its order with this pointed observation:  “Making false statements in attorney advertising harms the legal profession as a whole and damages the credibility of the lawyers making or authorizing the statements.”  Id.  True that.

The rubber hit the road with more friction when it came to the second transgression—violating the protective order.  Late one Friday night, the plaintiffs filed on the public docket documents that the defendant had designated confidential under the Court’s protective order.  Id.  Counsel had communicated earlier that day with defense counsel about a joint motion to file documents under seal, which implies they knew they were about to file confidential documents.  Id.  But they filed the documents in the public record anyway, without attempting to seal them.

The defendant notified plaintiffs’ counsel the following Saturday morning, which prompted counsel to remove the documents and file a proper motion to seal that day.  But because this all occurred after hours, the documents appeared in the public record for more than two days.

Here is the rub:  During that time, multiple users—including news organizations—accessed the documents using PACER.  In other words, when this tree fell, there was someone in the forest to hear it—indeed, multiple people, including people whose noble profession includes spreading the news.  One wonders how they knew to look in just the right place at just the right moment.

In response to all this, the district court put some bite into its order and granted sanctions under Rule 37(b) for counsel’s violation of the protective order.  Id.  The district court noted that sanctions “may serve either remedial and compensatory purposes or punitive and deterrent purposes” [Id. (quoting Falstaff Brewing Corp. v. Miller Brewing Co., 702 F.2d 770, 783 (9th Cir. 1983))], and opted here to compensate the defendant for reasonable fees spent addressing the protective order violation.  The court ordered the parties to meet and confer over the amount, and plaintiffs’ counsel ultimately agreed to pay $50,000.  Doc. 662 (Mar. 29, 2021).

That is a noteworthy sum for most, and while the district court characterized the sanction as compensatory, orders like this should have a deterrent effect, too.  We could also envision a case where intentional conduct or repeated offensives could call for punitive sanctions, although the district court did not see those circumstances here.  Defense counsel may have a different view, especially in light of the coincidence—and in the age of docket trackers and automatic dingers, it very well may have been a coincidence—that multiple PACER users viewed the documents over the weekend.

The upshot is that protective orders are worth it, and they ought to be followed.  This district judge agreed.

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The drive from our home to the Delaware courthouse takes no more time than the drive to the Philly courthouse. But those two courthouses are worlds apart. The Philadelphia Court of Common Pleas is plaintiffs’ heaven. Most judges there think everything should go to a jury, and most jurors there think heaps of money should go to plaintiffs. Forget about any sort of hometown advantage. Philly jurors feel no compunction about picking the pockets of local companies. It is all very … interesting.

Delaware is altogether different. Dare we say it? We think we usually get a fair shake in the New Castle County Courthouse. Even when we lose, the judges supply explanations and case citations. But let’s be candid: this love letter to Delaware would not be written if the judges there made a habit of blithely waving cases on to the twelve-headed monster. Delaware judges actually dismiss cases that should be dismissed.

All of which brings us to Camejo v. Angelina Pharma et al., 2021 WL 141338 (Del. Super. Ct. Jan. 15, 2021). The plaintiff claimed that a generic antidepressant drug caused him to suffer from priapism. Before you are tempted to make a joke quarreling with our use of the word “suffer,” you should know that the plaintiff also claimed that because he had no knowledge of the risks, he delayed treatment and ultimately became impotent at the age of 50. The plaintiff sued both the manufacturer of the generic drug he took as well as the manufacturer of the brand name drug he did not take.

The labels for both the brand and generic drugs contained warnings about priapism and impotence. The labels were identical at first, but later the generic label was altered somewhat. The court actually uses the word “diminished” in describing how the generic label moved to slightly different language and ceased prominent capitalization. The priapism warning became “indistinguishable” from other warnings in the generic label.

Both manufacturers moved to dismiss the complaint. The brand manufacturer resisted the claim of innovator liability, while the generic manufacturer pointed to preemption and deference to the FDA. Because the plaintiff was prescribed the drug and ingested it in Los Angeles, the Camejo court decided that California law governed the case. At this point, any defense hack might worry that such choice of law might make the motions unwinnable. No need to worry. Forget about it; it’s Wilmington.

The brand manufacturer had an easier time of it. The plaintiff had never consumed its product. Even California does not impose strict liability against a manufacturer who did not manufacture the allegedly defective product that allegedly caused injury. And while California’s wretched T.H. v. Novartis case permitted innovator liability, the generic and brand labels in that case were identical. In Camejo, the labels were different. There was no way in Camejo that the brand label misled the plaintiff or played any role in his injury. Accordingly, the innovator liability, negligence, and warranty claims against the brand manufacturer were also dismissed.

The different label might seem to create a stiff problem for the generic manufacturer, but the Delaware court still held that Pliva v. Mensing preemption applied. The plaintiff did not contend that the generic manufacturer changed the label without FDA approval. (From the court’s opinion we do not know what happened or why the generic manufacturer thought it a good idea to write a different label.) Moreover, even if the generic label was “diminished,” it was still plainly adequate. It stated the risk of priapism in detail, explaining the condition and possible consequences. The Camejo court concluded that the “diminished warning” claim “provides no reasonably conceivable basis for a finding of liability” against the generic manufacturer under California law.

The plaintiff wasn’t quite out of bullets yet. He invited the Delaware court “to be the first in the country to impose an affirmative duty on generic manufacturers to send ‘Dear Doctor’ letters … that reiterate certain warnings in the FDA-approved drug.” The court declined the invitation. Delaware calls itself The First State (because it was the first to ratify the U.S. Constitution), not the first stupid state. In Pliva, SCOTUS actually addressed Dear Doctor letters from generic manufacturers. Such letters must contain the same language as the label, without any adornment. The Camejo court reasoned that even a California court would see no sense in imposing a duty on a drug company “to pick out one of the myriad side-effect warnings (whether inadequately penned or not) from its product’s packaging, [and] draft and distribute a single side-effect-targeted letter to health care providers with just that exact warning language (again, whether inadequately penned or not).” Hard cases might make bad law, but this one was not hard.

For some reason, the Delaware court’s optimistic reading of California law makes us think of the ending of The Sun Also Rises. A woman tells her former lover that they could have had “a damned good time together.” The man, rendered impotent by the war, not a pharmaceutical, replies, “Isn’t it pretty to think so?”

In any event, we hope this summary of an eminently sensible Delaware court opinion gave you pleasure. But if you are still feeling this pleasure in four hours, definitely call a doctor.

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Outside of the law, if you hear “R&R,” you might think of “rest and relaxation” or the original military term “rest and recuperation.”  For many of us, the last year has had plenty of rest, but maybe not much true relaxation or recuperation.  As in-person trials are set and the world inches toward a “return to normality” (or the Hardingesque “normalcy”), many of us may not really be ready to rock and roll or rush and return just yet.  In litigation, “R&R” also means a “Report and Recommendation” issued by a magistrate judge under Fed. R. Civ. P. 72, which does not use the term.  We do not tend to write up R&Rs because they may be modified by the district judge in short order.  For some reason, though, this week’s batch of “bloggable” cases included two R&Rs and we picked one of them.  A fascinating insight into the sausage making of the Blog, for sure, but there is also a connection to the actual decision we will be discussing below.  In our experience, R&Rs often are a “mixed bag” or involve a fair amount of “baby splitting.”  Could this be because magistrate judges spend much of their time conducting court-ordered settlement conferences and the spirit of compromise lingers?  Or maybe the prospect of objections makes magistrates even more hesitant than district judges to have one side win a motion completely?  We do not really have proof either way and there are no defined burdens here.

In In re Abilify (Aripiprazole) Prods. Liab. Litig., MDL No. 2734, No. 3:19-cv-22 (N.D. Fla. Feb. 10, 2021), the magistrate judge considered a motion for summary judgment on referral.  The results were predictably mixed.  The facts were relatively straightforward:  the plaintiff was prescribed and took a prescription antipsychotic medication, both the branded and generic versions, for about three years, during which time FDA issued a safety communication about the risk of “uncontrollable urges to gamble, binge eat, shop, and have sex” with the medication and the branded label was updated to reflect these issues.  Id.at *1.  Plaintiff claimed to have “engaged in compulsive gambling, experienced hypersexuality, and struggled with substance abuse.”  Id.  He blamed the drug and asserted a number of claims under Rhode Island law.  (Rhode Island has not recognized innovator liability, so we assume the particular companies sued were the ones whose medications plaintiff actually took.)  Defendants moved for summary judgment on all of them.

After a few walk-overs, the magistrate turned to the contested claims.  We will follow the order of his analysis.  First up was failure to warn.  We like that the magistrate made clear that Rhode Island law requires the plaintiff to prove proximate cause.  We also like that the magistrate predicted that it was highly likely that the Rhode Island Supreme Court would adopt the learned intermediary doctrine, citing the same two prior federal decisions we do in our tally on the issue, and noting that the court had endorsed it implicitly.  Id. at *3.  We are less enthused by the failure to mention Erie restraint—see, it goes both ways—and the transition to discussing proximate cause.  When the magistrate writes “Some states have applied the learned intermediary doctrine to bar claims based on allegedly inadequate instructions or warnings accompanying a drug when there is no evidence that the prescriber read or relied on the drug’s label or instructions,” he is not describing a “bar” but a failure of the plaintiff to carry her burden.  This kind of language often presages an analysis of the evidence that tilts in favor of the plaintiff.

Here, although the court’s original recitation of the law made clear that plaintiff had the burden, consideration of burden seemed to go out the window.

Defendants cite [the prescriber] Dr. Scaramella’s deposition testimony that “he has never discussed impulsivity with any of his patients, even after reports of impulsivity were added to the Abilify warning label” and that “despite the change in the warning label, he cannot say … he would have changed the way he treated” Plaintiff.

Id. (citation omitted).  We also know that the plaintiff was in fact continued on the medication well after literature reports and the FDA’s communication on the compulsive behaviors at issue.  Yet, the one-sided evidence on (lack of) proximate cause for failure to warn was not enough.  This started with magistrate citing three old cases for the proposition that

courts routinely reject Defendants’ suggestion that a failure to warn claim may be defeated as a matter of law by a prescriber’s hindsight opinion that he would not have treated a patient differently if she received an adequate warning.

Id. (emphasis added).  Not only is that statement backwards—plaintiffs routinely try to carry their burden based on a prescriber’s hindsight guess about a change in behavior from a hypothetical warning—but the cases cited hardly establish a routine.  Suffice it to say that they date from 1984, 1991, and 1992, all involve federal courts applying state law, and at least one is probably not good law anymore.

With this background, the magistrate considered the evidence “equivocal at best.”  Id. at *4.  The prescriber testified that “he would have heeded the FDA’s instruction” to monitor for the development of new risks—which does not relate to the decision to prescribe.  Id.  And his answer on whether he would have done anything different with plaintiff was that he was “not sure.”  Rather than seeing this as a failure of plaintiff to carry his burden with record evidence, the magistrate found a triable issue on proximate cause, citing a Rhode Island procedural decision that summary judgment should only be granted “when the facts are undisputed and are susceptible of but one inference.”  Id. (citation omitted).  Sitting in diversity, though, only substantive state law applies along with Fed. R. Civ. P. 56 and the federal cases the decision had cited interpreting it.

The rest was better.  On design defect, Rhode Island’s consumer expectation test required a “strong likelihood of injury” due to the alleged defect.  Id. (citation omitted).  Plaintiff failed to introduce evidence “that [impulsivity disorder] rendered Abilify unreasonably dangerous because it presents a ‘strong likelihood’ of injury.”  Id.  Merely identifying a risk now described in the label was not enough.

Negligent misrepresentation fared no better.  Plaintiff claimed a misrepresentation in the air—the generalized promotion of the drug as “safe” without warning of the risk of impulsive disorders.  While the magistrate noted that plaintiff had disclaimed in deposition that he had relied on any statement from defendants—defeating one of the elements of the claim—he went further in rejecting that there was evidence in the record of a misrepresentation.  Id. at *5.  Specifically, the fact that medication was still on the market supported that it was “safe” and alleged omissions in the label did not equate to misrepresentations of anything.  Id.  If we are being picky, then we would say that we would like to see some consideration of how the learned intermediary doctrine affects the misrepresentation claim.

We will also get picky on the fraudulent concealment “claim,” even though summary judgment was granted on this one too.  This is not a claim, but a count included on many MDL template complaints as a way of seeking relief from the operation of a statute of limitation.  Too often, these poorly pleaded counts linger because individual complaints are rarely tested in MDLs.  As far as we can tell, though, defendants did not claim the case was time barred, so an exception to a defense was not really implicated.

Last up were claims for express and implied warranties.  The magistrate punted on whether the requirement of “reasonable notice” could be met by the filing of the lawsuit (without pre-suit notice) more than five years after starting the medication and more than two years after stopping it.  Id.  Instead, these claims fell on their merits.  An implied warranty claim required proof of product defect, so the summary judgment on the design defect claim applied.  An express warranty claim required proof of reliance on some statement from a defendant, so the summary judgment on the misrepresentation claim applied.  Overall, this bag is quite mixed from our perspective, but the plaintiff was left with a single claim of failure to warn that requires the jury to convert “equivocal” prescriber testimony into a finding of proximate cause.  From the defendants’ perspective, this bag may not be so mixed after all.

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Sometimes we get an opinion back from a court, and the reasoning leaves us scratching our heads and wondering, “Where did that come from?”  In the opinion, the court has decided the case on something that neither party ever argued.  We blogged about a case like that once, here.  In that case at least, we could tell where the court got the reasoning that it found dispositive – from an amicus curiae brief.  But usually, when that happens to us, we have no idea where the court got the idea – probably from some sharp judicial clerk’s research.

Well, it turns out there are limits on a court’s ability to do that.

Last term, in United States v. Sineneng-Smith, 140 S. Ct. 1575 (2020), a criminal case, the Court (in one of Justice Ginsburg’s last opinions), reversed the Ninth Circuit for going off on a tangent that neither party had asserted.  The opinion in Sineneng-Smith invoked something called the “party presentation” principle (the interesting thing we had never heard of), and held that that the Ninth Circuit had erred by deciding the case on a ground that had not been not been argued – or preserved – by the parties themselves.  Id. at 1578.  The Court explicitly stated that the limitations imposed by the parties’ presentations applied in both criminal and civil litigation:

In our adversarial system of adjudication, we follow the principle of party presentation. . . .  “[I]n both civil and criminal cases, in the first instance and on appeal . . ., we rely on the parties to frame the issues for decision and assign to courts the role of neutral arbiter of matters the parties present.”

Id. at 1579 (quoting Greenlaw v. United States, 554 U.S. 237, 243 (2008)).  So this “party presentation principle” is potentially useful to us civil litigators, too.

While the party presentation principle is “not ironclad,” “departures . . . have usually occurred to protect a pro se litigant’s rights.”  Id. (citation and quotation marks omitted).  Sineneng-Smith made clear that judges deciding cases on unargued grounds is very much an exception to proper jurisprudence:

[A]s a general rule, our system “is designed around the premise that [parties represented by competent counsel] know what is best for them, and are responsible for advancing the facts and argument entitling them to relief.”

140 S. Ct. at 1579 (quoting Castro v. United States, 540 U.S. 375, 386 (2003) (concurring opinion).

Given Sineneng-Smith and the opinions it quotes, the Supreme Court has evidently addressed the party presentation principle at least three times since the turn of the century – which is more times than it has restated the principle of Erie conservatism, another doctrine that exists to constrain judges from simply doing their own thing.  Thus, Sineneng-Smith cautions:

Courts are essentially passive instruments of government.  They do not, or should not, sally forth each day looking for wrongs to right.  They wait for cases to come to them, and when cases arise, courts normally decide only questions presented by the parties.

140 S. Ct. at 1579 (citation and quotation marks omitted).  These sentiments resemble those of Justice Benjamin Cardozo, who wrote, that a judge “is not a knight-errant, roaming at will in pursuit of his own ideal of beauty or of goodness.”  The Nature of the Judicial Process, at 141 (1921).

To us this means that, if we are on the receiving end of an adverse decision that turns on some ground that the plaintiff never argued, then the party presentation principle is another possible basis for overturning that decision.  We caution that the facts in Sineneng-Smith were pretty blatant – the Ninth Circuit panel sua sponte appointed amici curiae to argue the new ground that it came up with, and the appellant’s argument “fell by the wayside,” 140 S. Ct. at 1580-81 – but the principle would appear to apply whenever a judge’s decision to decide a case on unargued grounds works a “radical transformation” of that case.  Id. at 1582.

We grew up with the adage (attributed to Franz Kafka) that “it is better to have and not need than to need and not have.”  Maybe we’ll never need it, but this party presentation principle is something else to have in reserve, just in case.

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We’ve blogged about the United States Supreme Court’s pending personal jurisdiction cases before.  Well, they pend no longer.  Yesterday the Court unanimously (with a couple of concurrences) ruled that resident plaintiffs injured by products originally manufactured and sold elsewhere could sue a nationwide company like Ford – that “purposefully avail[ed] itself of the privilege of conducting activities within the forum State” – in their home states, rather than sue only where such a defendant was “at home.”  Ford Motor Co. Montana Eighth Judicial District Court, ___ S. Ct. ___, 2021 WL 1132515, at *4 (U.S. March 25, 2021) (here is the slip opinion for those without the luxury of law firm resources).

While plaintiffs in product liability litigation involving durable, mobile products dodged a jurisdictional bullet in Ford v. Montana, we don’t view this case as bad news for our clients selling single-use products that continually face masses of forum-shopping litigation tourists.

We explain.

First and foremost, the key fact – emphasized throughout Ford v. Montana – is precisely that those plaintiffs were not litigation tourists.  From the very first paragraph of the opinion:

The accident happened in the State where suit was brought.  The victim was one of the State’s residents.  And [defendant] did substantial business in the State − among other things, advertising, selling, and servicing the model of vehicle the suit claims is defective.

2021 WL 1132515, at *3.  And again:

[H]ere, the plaintiffs are residents of the forum States.  They used the allegedly defective products in the forum States.  And they suffered injuries when those products malfunctioned in the forum States.  In sum, each of the plaintiffs brought suit in the most natural State.

Id. at *8.  See id. at *7 (describing cases as “brought by state residents”), *8 (jurisdiction “when the product malfunctions there”); id. (invoking state interest in “providing [their] residents with a convenient forum”); at *9 (“resident-plaintiffs allege that they suffered in-state injury”).

For our purposes that matters a lot, because the Supreme Court took pains to clarify the basis for its recent Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), decision as barring personal jurisdiction over suits brought by forum-shopping non-residents whose injuries and product use occurred elsewhere.  Shutting down litigation tourism has always been at the core of our interest in personal jurisdiction.

Since BMS was decided, plaintiffs have relied on a recitation (in the facts section of that opinion) of the what the BMS plaintiffs failed to show – that the defendant “did not develop” the product, “did not create a marketing strategy,” and “did not manufacture, label, package, or work on the regulatory approval of the product” in the forum state, 137 S. Ct. at 1778 – as a wish list.  They argue that  even litigation tourists can use such purported contacts to assert “specific” personal jurisdiction, all the while ignoring the BMS court’s recitation of what had been affirmatively proven:

As noted, the nonresidents were not prescribed [the drug] in California, did not purchase [the drug] in California, did not ingest [the drug] in California, and were not injured by [the drug] in California.  The mere fact that other plaintiffs were . . . does not allow the State to assert specific jurisdiction over the nonresidents’ claims.

BMS, 137 S. Ct. at 1781.

That route should no longer be open to litigation tourists.  Ford v. Montana made it crystal clear just what the BMS Court had “emphasiz[ed],” 2021 WL 1132515, at *8, in reaching the conclusion that specific personal jurisdiction could not lie:

We found jurisdiction improper in [BMS] because the forum State, and the defendant’s activities there, lacked any connection to the plaintiffs’ claims.  The plaintiffs, the Court explained, were not residents of California.  They had not been prescribed [the drug] in California.  They had not ingested [the drug] in California.  And they had not sustained their injuries in California.  In short, the plaintiffs were engaged in forum-shopping − suing in California because it was thought plaintiff-friendly, even though their cases had no tie to the State.

Id. (BMS citations omitted) (emphasis added).

We mentioned in reviewing the oral argument that “litigation tourism has a bad name,” and boy were we right about that. Non-resident forum-shoppers cannot constitutionally assert specific personal jurisdiction, absent in-state product use or injury:

Yes, [defendant] sold the specific products in other States, as Bristol-Myers Squibb had.  But here, the plaintiffs are residents of the forum States.  They used the allegedly defective products in the forum States.  And they suffered injuries when those products malfunctioned in the forum States.

Id.  That is the court-described “key part” of BMS’s rationale why personal jurisdiction was unconstitutional in that case.  Id. at *9.  Forum shoppers lack any “affiliation between the forum and the underlying controversy,” id. at *5 (quoting BMS), and that’s what mattered – not any supposedly missing facts about a defendant’s forum contacts that litigation tourists might be able to dredge up.

Our second observation is that we question whether there is anything left of “stream of commerce” personal jurisdiction after Ford v. Montana.  Given the roundabout way that the particular products at issue reached the forum states, through “later resales and relocations by consumers,” 2021 WL 1132515, at *3, Ford v. Montana had all the makings of a stream of commerce case.  But “stream of commerce” is nowhere mentioned, even though plaintiffs and most of their amici relied (in part) on stream of commerce cases.  The only basis for jurisdiction that the Court addressed was whether the litigation was sufficiently “related to” (which the Court treated as separate from “arising from,” 2021 WL 1132515, at *5) the defendant’s contacts with the relevant states.

Thus, to the extent that “stream of commerce” claims involve defendants that plaintiffs can allege “extensively promoted, sold, and serviced” the allegedly “defective product” in the forum state, 2021 WL 1132515, at *9, they will no longer need to rely on a stream of commerce theory.  That takes the more sympathetic cases out of the mix.  As for the rest, lacking “systematic contacts,” id. at *7 – the cases in which stray products find their way into states where defendants did not otherwise market them – Ford v. Montana provides cold comfort:

That does not mean anything goes.  In the sphere of specific jurisdiction, the phrase “relate to” incorporates real limits, as it must to adequately protect defendants foreign to a forum.

Id. at *5.  Jurisdictional “contacts must be the defendant’s own choice and not “random, isolated, or fortuitous.”  Id. at *4 (citation and quotation marks omitted).  See Id. at *9 (discussing lack of defense forum contacts in Walden v. Fiore, 571 U.S. 277 (2014)).

Ford v. Montana certainly suggests, if not outright holds, that “specific jurisdiction attaches . . . when a company like [defendant] serves a market for a product in the forum State.”  Id. at *6.  Thus, defendants in cases like Asahi Metal Industry Co. v. Superior Court, 480 U. S. 102, 110 (1987), and J. McIntyre Machinery, Ltd. v. Nicastro, 564 U.S. 873 (2011), can cite Ford v. Montana as further authority for the absence of specific personal jurisdiction in fortuitously-located product cases, where there is no evidence that they “deliberately extended” their product marketing into wherever they are being sued.  2021 WL 1132515, at *6.

Third, and finally, we point out something else we mentioned in our oral argument post – the looming presence of e-commerce.  Footnotes in Ford v. Montana suggest to us that the Court is ready to delve into cutting edge personal jurisdiction issues involving allegations of Internet-based product sales and other contacts.

One of the concurrences here expresses a worry that our [jurisdictional] body of law is not “well suited for the way in which business is now conducted,” and tentatively suggests a 21st-century rethinking.  Fair enough perhaps….

Id. at *5 n.2.  A bit later on, “we do not here consider internet transactions, which may raise doctrinal questions of their own.”  Id. at *7 n.4.  We don’t hazard a guess how the Court would rule in an Internet-only forum contacts case, but we flag the issue because it is likely to arise at the Supreme Court level in the relatively near future.

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A Vaudeville act is supposed to leave the audience wanting more. Not so a judicial decision. But that is what we have today: a decision whose result—the dismissal of Lanham Act claims brought by a device manufacturer against a competitor—is underexplained.

The plaintiff in Impact Applications, Inc., v. Concussion Management, LLC, 2021 WL 978823 (D. Md. 2021), manufactures a computer-based device that helps assess and manage concussions. So does the defendant. The plaintiff’s device was classified and cleared by the FDA; the defendant’s was not.

The plaintiff sued under the Lanham Act, which creates a private right of action for “false or misleading description[s] of fact, or false or misleading representation[s] of fact” that “misrepresent[] the nature, characteristics, [or] qualities … of [the speaker’s] or another person’s goods.” 15 U.S.C. § 1125(a). The plaintiff claimed that the defendant had misrepresented the defendant’s device by implying that it had been reviewed and cleared by the FDA, by suggesting that it possessed qualities that only FDA-cleared devices possess, and by falsely asserting that it was superior to plaintiff’s device despite lacking FDA clearance.

The court dismissed the plaintiff’s claims, but its analysis is unsatisfying.

The court concluded that the plaintiff’s claim that the defendant had misrepresented its device by falsely implying that it had been reviewed and cleared by the FDA was not actionable for two reasons. First, the court relied on a couple cases holding that only explicit, not implicit, misrepresentations of FDA approval are actionable under the Lanham Act. Why is that? The court doesn’t say. Second, quoting the Fourth Circuit’s decision in Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130 (4th Cir. 1993), the court found that allowing a Lanham Act claim based on implicit misrepresentation of FDA clearance “would, in effect, allow the plaintiff to use the Lanham Act as a vehicle by which to enforce the FDCA.” 2021 WL 978823, at *6 (internal quotation marks omitted). Why is that? Because the alleged misrepresentation could be deemed misbranding under 21 U.S.C. § 352? Again, the court doesn’t say. Unfortunately, neither does Mylan.

The court also rejected the plaintiff’s claim insofar as it was based on the defendant’s supposed suggestion that its device possessed qualities that only FDA-cleared devices possess. Understandably perplexed by the plaintiff’s assertion that only FDA-cleared device can possess certain qualities, the court found that the claim would require it “to interpret and apply the FDCA in order to determine what qualities only an FDA-approved device can have and determine, before the FDA has had an opportunity to do so, whether [the defendant’s] products have those qualities.” 2021 WL 978823, at *7.

What the plaintiff and court mean by “qualities only an FDA-approved device can have” is far from obvious. Perhaps it is an inartful way of saying that devices with certain characteristics must receive FDA approval before being marketed. So understood, plaintiff’s claim might be construed as resting on the contention that the defendant’s device required FDA approval given its characteristics and that by selling a device with those characteristics the defendant impliedly represented its device as FDA-approved. If construed in this manner, adjudication of the claim—which sounds like a variant of the plaintiff’s first claim—would force the court to determine whether the defendant’s device in fact required FDA approval. That seems to be what the court was thinking, as it cited two earlier Lanham Act cases for the proposition that a “Lanham Act claim that requires direct application or interpretation of the FDCA or FDA regulations is within the FDA’s jurisdiction.” 2021 WL 978823, at *7 (internal quotation marks and alterations omitted).

That is well and good, but why is it so? There are two possible reasons, neither of which the court clearly articulated.

First, there is the doctrine of primary jurisdiction—discussed, inter alia, here, here, here, and here—which, under certain circumstances, allows a court to stay an action or dismiss a complaint without prejudice pending the resolution of an issue within the special competence of an administrative agency. Whether a device that is purported to help assess and treat concussions requires FDA clearance is certainly an issue within the FDA’s special competence.

Second, there is implied preemption under 21 U.S.C. § 337(a), which declares that all actions to enforce the FDCA “shall be by and in the name of the United States.” As readers of the blog know, that provision—interpreted by the Supreme Court in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)—prohibits private plaintiffs from attempting to enforce the FDCA. A Lanham Act claim that seeks to impose liability based on the defendant’s failure to obtain FDA approval when purportedly required is effectively an attempt to privately enforce the FDCA in contravention of § 337(a).

Product-liability plaintiffs suing drug and device manufacturers routinely try to evade § 337(a). Sometimes they invoke state negligence-per-se doctrine; other times they assert claims under consumer-protection statutes. Those attempts are rightly denounced by defendants—and often rejected by courts—as thinly veiled attempts to privately enforce the FDCA.

We should therefore cheer any decision that dismisses claims barred by the FDCA even when they are brought under a different statute. But the readers of this post and of the underlying decision are left wondering how exactly the Impact Applications court reached that result that it did.

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Ray Charles’s musical threat of “tell your Ma, tell your Pa, gonna send you back to Arkansas” doesn’t sound so bad to us after reading Green v. Bayer Corp., 2021 WL 687024 (E.D. Ark. Feb. 22, 2021). The plaintiff alleged injuries from a permanent contraceptive device and brought claims for negligent training, negligent risk management, and breach of express warranty. The defendants moved to dismiss on the grounds that the claims were preempted and insufficiently pled. The court granted the motion to dismiss and denied the plaintiff’s motion to amend.

We are skeptical of the claim of negligent training. (Here is excellent article on that topic that is worth retrieving if you bump up against the claim: J. Eppensteiner & R. Nelson, “Failure to Train and Medical Device Claims,” For the Defense (April 2013).) In Green, that claim was especially frail because the contraceptive product was a class III medical device subject to express preemption. Any effort to impose a training requirement beyond FDA requirements was a clear no-go. The claim could survive only if it involved a valid claim under Arkansas law that ran parallel to FDA regulations. It did not. The plaintiff stretched Arkansas law in an effort to show a voluntary undertaking, but it did not matter because the plaintiff set forth no facts showing either how the physician training departed from FDA requirements or how such departure caused the plaintiff’s injuries. Goodbye, training claim.

We admit we do not even know what a claim of negligent risk management is. But whatever it is, the plaintiff in Green did not adequately plead it. The Green court was also unsure what the claim was exactly, but charitably interpreted it to assert that the defendants had not notified the FDA about problems. The complaint listed several alleged federal violations, including failure to submit certain reports. That sort of thing amounts to a fraud-on-the-FDA claim, which is preempted. In any event, the negligent risk management claim does not exist under Arkansas law. Even if it did, it suffered from the same flaw as the negligent training claim: lack of a causal link. Farewell, negligent risk management claim. We hardly knew ye. Actually, to be honest, we never knew ye.

The plaintiff alleged that the defendants falsely advertised the contraceptive product. She said she relied on representations on the defendants’ websites. But she did not specify exactly how anything on the website was false. A vague/overbroad allegation that the other side lied does not cut it. Adios, warranty claim.

The plaintiff proposed an amended complaint that did not fix the dismissed claims but added claims for negligent manufacture, strict liability defective manufacturing, and failure to warn. We do not even need to read the complaint to know the manufacturing claims were bogus. They pretty much always are. But the Green court did read the amended complaint, saw no there there, saw that the failure to warn claim was premised on the same facts as the warranty claim, and concluded that amendment would be futile.

The Green court made dismissal of the product liability claims look easy. Maybe it was.

(This not our first post on the Essure litigation. For earlier examples, see here and here.)

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Last week we posted about the Daubert decision in Lowery v. Sanofi-Aventis LLC, that tossed out both plaintiff’s medical causation expert and FDA expert.  As promised, that was just the first blow.  The knockout came in its companion decision granting summary judgement not just on medical causation but also on the grounds of preemption.

First a quick reminder that the product at issue is a Class III medical device that is a gel-like substance that is injected into the knee to reduce pain.  It is undisputed that plaintiff’s injection came from a product lot that was later found to be contaminated.  Lowery v. Sanofi-Aventis, 2021 WL 871344, *1 (N.D. Ala. Mar. 9, 2021).  So, “[o]n the surface, this claim may seem meritorious.  After all, the device was contaminated with bacteria.  But that is not the whole story.”  Id.  Indeed, it is just the beginning.  Because while “some cases seem viable upon their initial presentment, they can fall apart when the legal standards affecting expert testimony are applied and Congress’s policy choices come in to play.”  Id.  And that is the part of the story we are most interested in.

This story is told in two chapters.  First, plaintiff’s claims fail under Alabama law for lack of medical causation.  As pointed out in our prior post, plaintiff’s medical expert was not qualified to render his opinions and his opinions themselves were unreliable because they were not based on generally accepted scientific methodologies (they were largely based on temporal proximity and parroting the medical records).  So, on summary judgement plaintiff was left with no expert evidence that he actually suffered from the condition known as septic arthritis or that the contaminant causes septic arthritis generally or caused plaintiff’s septic arthritis specifically.  Id. at *8.  Instead, plaintiff tried to rely on defendant’s internal company documents and the testimony of plaintiff’s treating physician.  “Even if Defendant’s documents can be said to be a legally sufficient substitute for expert testimony to establish general causation,” at most those documents identified septic arthritis as a potential risk of the bacteria.  Id.  A mere possibility, “does not reliably establish general causation.”  Id.

As for plaintiff’s treating physician, he was asked at his deposition if a “reasonable physician [could] conclude tat this was . . .  septic arthritis from a contaminated lot of [the device].”  Id. at *9.  The assented to that statement.  That testimony does not come close to satisfying Daubert.

[The treater’s] statement that it was possible Plaintiff suffered from septic arthritis does not indicate that it is [the treater’s] medical opinion that Plaintiff had septic arthritis, much less what caused it. Nor does [the treater’s] statement that a “reasonable physician” could conclude Plaintiff suffered from septic arthritis indicate what [his] medical opinion about Plaintiff’s condition actually was. . . [N]othing supports the assertion that [the treater] concluded that Plaintiff suffered septic arthritis because of Defendant’s product—let alone that he conducted an analysis that would withstand Daubert scrutiny.

Id.  (citations omitted, emphasis in original)

This story could have ended there, but wanting to be efficient, the court wrote chapter two.

[E]ven if Plaintiff’s state-law claims were viable (and, to be clear, they are not), Plaintiff’s claims are preempted because they impose requirements in addition to, or different from, those required by the FDA under federal law.

Id. at *7.  The injection at issue here was subject to the device-specific requirements of its PMA and the generally applicable requirements of the FDA’s Good Manufacturing Practices (GMPs).  Id. at *14.  We would normally take issue with GMPs being found sufficient to form the basis of a parallel violation claim, but this is the Eleventh Circuit and therefore controlled by Godelia v. Doe 1, 881 F.3d 1309 (11th Cir. 2018), which just happens to be one of our top ten worst cases of 2018.  And it didn’t impact the court’s conclusion:

To assert a parallel claim, a plaintiff must “set forth” evidence of “specific violations” of “specific regulations.” Importantly, not only must a plaintiff show that a federal requirement has been violated but he must also “causally connect the simultaneous violations of federal and state law … to the alleged injury.”

Id. at *15 (citations omitted, emphasis in original).  Plaintiff failed to connect Defendant’s conduct to any “specific binding regulation.”  Id. at *16.  Plaintiff could not rely on the criticisms of his FDA expert because she was excluded.  He was left to point to only FDA guidance documents and regulations applicable to pharmaceuticals.  Id.  Plaintiff is correct that the FDA has offered “guidance” on certain applicable processing and testing procedures.  But guidance documents are non-binding, as stated in the documents themselves.  They are not final agency actions, but rather reflect the FDA’s “current thinking” on the given topic.  Id. at *17. While informative in some contexts, a deviation from the practices suggested in an FDA guidance, do not support a parallel violation claim.  Id.

So, while plaintiff alleged defendant violated the FDA’s GMP Guidance on Endotoxin Testing, what plaintiff failed to do was cite “a single specific GMP that the allegedly deficient endotoxin testing violated.”  Id. at *18 (emphasis in original).  Further, the one GMP that plaintiff does allege defendant violated is applicable to pharmaceuticals not medical devices.  The FDA defines and regulates pharmaceuticals and medical devices differently.  The GMPs applicable to one cannot be applied by the courts to the other. Failure to demonstrate any violation of GMPs was also fatal to plaintiff’s claim that defendant’s product was adulterated.  Id. at *20 (adulteration requires a finding of non-conformity with applicable requirements).  And plaintiff’s argument that defendant was not prohibited from doing additional testing is “of no moment.”  A state cannot make obligatory a federal requirement that is merely permissive.  Such a state requirement would be different from or in addition to federal requirements.  Id.

Even if there were evidence of a parallel violation “(and, to be clear, there is not),” plaintiff’s claims would still be preempted because there is no evidence that defendant’s conduct caused plaintiff’s injury.  Id. at *16.  For example, plaintiff offers no evidence that if the endotoxin testing had been done differently it would have led to different results that would have meant plaintiff would never have received an injection from the contaminated lot.  Id. at *19.  Without a causal link, plaintiff’s claims are preempted.

Without expert evidence, causation evidence, or a parallel violation – plaintiff’s claims went down for the count.

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A couple of years ago, we chastised a Third Circuit panel in our “Wrong Court” post, pointing out that its decision to declare an Internet marketing platform a “seller” under Pennsylvania law improperly usurped state judicial power under Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938).  That decision, Oberdorf v. Amazon.com, Inc., 930 F.3d 136 (3d Cir. 2019), was subsequently vacated, rehearing granted on precisely these grounds, and ultimately certified to the Pennsylvania Supreme Court for resolution.  See Oberdorf v. Amazon.com, Inc., 818 F. Appx. 138 (3d Cir. 2020).  That was the proper disposition under Erie because state courts, not federal courts exercising diversity jurisdiction, should decide whether to recognize novel theories of tort liability.  As the United States Supreme Court has repeatedly stated:

[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.

Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988); accord, e.g., Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988); Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975).  For a complete discussion of related United States Supreme Court precedent, see this post.

Perhaps no circuit has been as firm in enforcing the federalist principle that federal courts applying state law should show such restraint than the Third Circuit.  In “Wrong Court” we listed over a dozen examples:  Sheridan v. NGK Metals Corp., 609 F.3d 239 (3d Cir. 2010); Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238 (3d Cir. 2010); Lexington National Insurance Corp. v. Ranger Insurance Co., 326 F.3d 416, 420 (3d Cir. 2003); Werwinski v. Ford Motor Co., 286 F.3d 661 (3d Cir. 2002); City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415 (3d Cir. 2002); Camden County Board of Chosen Freeholders v. Beretta, U.S.A. Corp., 273 F.3d 536, 541-42 (3d Cir. 2001); Northview Motors, Inc. v. Chrysler Motors Corp., 227 F.3d 78, 92 n.7 (3d Cir. 2000); Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994) Adams v. Madison Realty & Development, 853 F.2d 163 (3d Cir. 1988); Falcone v. Columbia Pictures Industries, 805 F.2d 115 (3d Cir. 1986); Bruffett v. Warner Communications, 692 F.2d 910 (3d Cir. 1982); McKenna v. Ortho Pharmaceutical Corp., 622 F.2d 657 (3d Cir. 1980).  For a more complete discussion of this Third Circuit precedent (as of 2009), see this post.

Unfortunately, Erie has been transgressed, indeed ignored, again – this time in the MDL context, which makes the error particularly dangerous (a novel state law theory exerts settlement pressure in thousands of cases), and particularly hard to correct (judicial errors disadvantaging defendants in MDLs are notoriously hard to appeal).  The decision is In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2021 WL 222776 (D.N.J. Jan. 22, 2021), and the issue is express warranty.

The Valsartan MDL, as readers may remember from our prior posts, involves claims that certain drugs were contaminated with nitrosamines – the same class of allegedly carcinogenic compounds that anyone who eats bacon or other processed foods is already exposed to in larger doses than could exist in tiny pills.  Since it’s an MDL – which more properly stands for “Maximized and Distorted Litigation” – plaintiffs sued everyone conceivable under every conceivable theory of liability, and some that haven’t been conceived yet.

One of the latter types of theories was involved in today’s decision.  Plaintiffs were suing over generic drugs, which means they have every incentive to be creative to surmount the formidable barrier of generic preemption.  See generally our Generic Preemption Scorecard.  So they came up with an “express warranty” theory of liability that no court anywhere (federal or state) had adopted.

The drug in question is “a drug of choice in lowering high blood pressure.”  2021 WL 222776, at *5.  Further, the alleged impurities did not interfere with the drug’s anti-hypertensive activity, so every plaintiff received an effective medication.  Id. at *3-4.  It’s hard to come up with a valid express warranty claim under those circumstances.  In brief, the express warranty theory the Valsartan plaintiffs invented was:

Common Law Breach of express warranties by all defendants because inclusion of defendants’ VCDs [Valsartan containing drugs] in the U.S. Orange Book serves as a warranty that the VCDs at issue constituted a generic drug that is bio-equivalent in every way to the patented drug.

Id. at *5 (emphasis original).  Note the use of “common law” – there can be no dispute that the relevant issues involve predictions of state law to which the Erie doctrine applies.

After punting on state law notice issues (as Bexis’ book demonstrates – Beck & Vale, Drug & Medical Device Product Liability Deskbook §2.08, at nn. 16.1 to 16.2 (updated 2020) – the states vary widely on this issue), Valsartan describes plaintiffs’ warranty theory in stark detail:

Plaintiffs argue [manufacturer] defendants’ express warranties arise not from statements in the product labeling, but from the very act of naming the product by the generic active ingredient, that is, by calling their generic drug “valsartan” or “valsartan HCT”, etc., in patient information leaflets dispensed with each prescription, or on a third-party beneficiary basis.  Plaintiffs further argue that, based on the prescription alone, plaintiffs could not have bought any other generic drug but valsartan (or VCDs), and that [manufacturer] defendants’ naming their [product] “valsartan” necessarily left plaintiffs no choice but to “rely” on [manufacturer] defendants’ name of the product, which stands as the basis for the bargain between [manufacturers] and plaintiffs.

Id. at *10 (emphasis added).

We’ve litigated a few prescription medical product liability litigation cases in our days, and we’ve also read a lot of decisions from such litigation, but we’ve never seen any statute or caselaw recognizing an express warranty claim based on nothing more than the name of the product as compiled in some official publication.  Nor have we seen a state-law warranty claim based on something, like the name of bioequivalent drug (a/k/a “reference listed drug”), that the FDCA mandates be in approved drug labeling (and in the so-called “Orange Book”).  E.g., 21 C.F.R. §314.94(a)(4-6, 8).  Indeed, insofar as reliance/basis-of-the-bargain is concerned, this “warranty” theory strongly reminds us of “fraud on the FDA” – another made-up, FDCA-based cause of action which was also created to evade a reliance/causation element (a product’s mere presence in the market being because of fraud to avoid the learned intermediary rule).

Nor, apparently, did plaintiffs or Valsartan itself cite a scrap of precedent that the name of a drug, in and of itself, could be an express warranty.  The entire discussion of Valsartan’s decision that this theory could state an express warranty claim under the laws of all fifty states is as follows:

The [manufacturers’] very naming of the drug as valsartan or valsartan-containing amounted to an express warranty on which plaintiffs had no choice but to “rely” when they were prescribed the drug and bought it as a medication for their high blood pressure.  Plaintiffs did not have to “perceive” the package labelling or insert in order to create a benefit of the bargain.  All they had to know was they were buying a generic drug that contained valsartan because the very name “valsartan” or “valsartan-containing” constituted itself an express warranty that what plaintiffs were purchasing was the chemical equivalent of the Orange Book pharmaceutical.

Id. at *11 (emphasis added).  What was the authority for this you-don’t-even-have-to-be-aware-of-it version of “express warranty?”  This:

See, e.g., Gremo v. Bayer Corporation, 469 F. Supp.3d 240, 258 (D.N.J. 2020) quoting “‘A statement can amount to a warranty, even if unintended to be such by the seller, if it could fairly be understood … to constitute an affirmation or representation that the [product] possesse[s] a certain quality or capacity relating to future performance.’  Volin v. General Electric Company, 189 F. Supp. 3d 411, 420 (D.N.J. 2016) (citations omitted).”

Id.  That is all.  Nowhere does Valsartan mention that some states have product liability acts and decisions holding that common law claims for express warranty have been subsumed, see, e.g., Seavey v. Globus Medical, Inc., 2012 WL 253116, at *2 (D.N.J. Jan. 26, 2012), so the opinion’s premise of a state-law express warranty claim common to all states is invalid.

Neither of the cited cases has anything to do with the unique, hypothesized form of name-only express warranty in Valsartan.  As to express warranty, Gremo (a bad case we blogged about here), involved the usual allegation of safety-related claims (“generally safe”; “not any less safe,” “pose a risk”), and was no way based on merely the name of the product, or on anything else that the defendant has no choice under the FDCA but to include in product labeling.  469 F. Supp.3d at 258.  Volin does not involve any FDA-regulated product at all, but only an oven.  The “certain quality or capacity” at issue in Volin likewise was completely different from the name of the product.  189 F. Supp.3d at 421 (“only specific allegation of an express statement is that the owner’s manual instructs the user to ‘Push the control knob in and turn it to the LITE position’”).

We presume that, since that is all that Valsartan cites, that is the best that the plaintiffs presented in their MDL briefing in support of their name-only express warranty claim.  In other words, there appears to be no law anywhere (which is what our experience tells us is the case), recognizing an “express warranty” based on nothing more than the FD-recognized name of a prescription drug.  So Valsartan recognized a novel form of express warranty – under the “common law” (actually express product warranties are governed by state UCCs, not the common law) of all 50 states in direct violation of Erie federalism, as enunciated in multiple precedents from the United States Supreme Court and the Third Circuit.  What’s worse is that the opinion appears entirely oblivious to the constitutional ramifications of what it did.  Nowhere in the opinion is any citation made to any case involving Erie principles, nor is there any recognition that a “prediction” of state law was being made.

Nor is there any case that we’ve seen involving generic preemption that allowed any claim predicated on the purported “falsity” of a statement that the FDCA and FDA regulations require be included in generic drug labeling.  In this respect this purported “express warranty” claim is simply another disguised “stop selling” claim preempted under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  As to preemption, we have three other observations:  (1) the FDA itself reviews drug names so that companies don’t use names that convey results or otherwise mislead (e.g., no antidepressants called “Happify” or “Pleasurac”); (2) the drug’s name, itself is a required part of the label; and (3) FDA approval of an ANDA is an agency determination that the generic is “comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.”  See FDA website.  Thus, there are multiple routes to preemption of the Valsartan plaintiffs’ express warranty claim that do not involve the “Orange Book.”

We hope that the manufacturer defendants in Valsartan do not let this unprecedented (in several ways) “express warranty” ruling stand.  This ruling both makes a travesty of the Erie doctrine and should be preempted for attacking an FDA-mandated labeling statement.  It is difficult, in an MDL, to obtain appellate review of errors, no matter how egregious.

*          *          *          *

On another, less controversial, aspect of the same Valsartan opinion, we also note that Magnuson Moss claims based on FDA-regulated labeling were properly dismissed.  Valsartan, 2021 WL 222776, at *20-21.  This part of the opinion is the only part that contains a significant discussion of case authority.  This issue was also the subject of one of our recent blogposts, here.  The previous two sentences may be related.

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In addition to having Green Mountains, maple syrup, lake houses, an ice cream company run by summer camp buddies, a mitten wearing Senator, and a history of low COVID rates, Vermont has a history of being a legal outlier.  Some of its positions might be considered progressive or regressive.  The legislation discussed here is a (bad) example of the former.  The latter is exemplified by its position on the learned intermediary doctrine.  As we noted recently, there are very few states left where the high court has not adopted the learned intermediary doctrine or a federal court has not predicted that it would.  Until last week, Vermont was among the holdouts.  No longer.  (We will not weigh in on how Levine was impacted by this issue and how things might have been different if Vermont had been following the majority position back in 2004.)

Leavitt v. Ethicon, Inc., No. 2:20-cv-00176, 2021 WL 872696 (D. Vt. Mar. 9, 2021), bears some commonalities with some other cases we have been posting about recently.  It is a pelvic mesh case remanded from one of the MDLs after being there for more than six years.  (We cannot say whether it untimely filed, because the decision does not indicate the date for any revision surgery or the onset of alleged injuries, but the device at issue was implanted back in 2009 and the plaintiffs did plead a “count” for “discovery rule and tolling.)  When it was remanded, a motion for summary judgment had been pending for a year.  This is not a story about delaying justice, though.  This is one where it probably helped for the court deciding a Vermont state law issue to be in Vermont, even if it was a federal court and the task involved predicting what the Vermont Supreme Court would do.

The facts of the case are fairly simple and familiar.  The plaintiff received a prescription medical device as part of a surgery to repair her stress urinary incontinence.  On summary judgment, because of which claims were challenged and which were dropped, only those sounding in failure to warn were at issue.  The prescribing/implanting doctor did not rely on the IFU for the device.  The plaintiff (switching to singular to ignore the consortium plaintiff for the rest of the post) probably received a patient brochure, but she did not rely on it.  Instead, she relied on what the doctor told her (which was, in turn, not based on anything the defendant made).  This fact pattern sounds familiar enough that we have a whole survey on it.

The first step, though, was deciding if the learned intermediary doctrine should apply to the claims here.  The prediction of what the Vermont Supreme Court would do was based on three observations.  First, “where Vermont law is undeveloped, the Vermont Supreme Court frequently looks to the Restatement for guidance.”  Id. at *5 (citation omitted).  The Restatement (Third) of Torts, from way back in 1998, had adopted the learned intermediary doctrine for all prescription medical devices.  Second, citing the 2014 tally from the MDL court in the Tyree case, “forty-eight states have adopted, or a federal court has predicted the state’s highest court would adopt, the learned intermediary doctrine.”  Id at *5 & n.4.  The court predicted Vermont was likely to follow this “overwhelming majority.”  Id. at *5.  Third, “the learned intermediary doctrine reflects the realities of patient consultations and identifies the best source of information regarding the risks and benefits of a particular device or procedure for a particular patient.”  Id. at *6.  We like this one best.  Together with the others, there was more than enough to support a prediction that the Vermont Supreme Court would adopt the learned intermediary doctrine and we have updated our survey.  (Note that we were already citing a lower Vermont decision not cited in Leavitt.)

With that, plaintiff’s claims based on an alleged failure to warn her fell.  Her claims based on allegedly failing to warn her prescribing/implanting doctor were left, but they had major causation issues.  As we noted up front, though, Vermont can be a bit quirky.  It applies a heeding presumption to (non-learned intermediary) warnings claims.  Id. at *6-7.  But it does recognize, even with the presumption, there can be no proximate cause for failure to warning when there is proof that the user would have ignored any warning.  Id. at *7.  Applying those principles, and acknowledging the cases defendant cited where a physician’s failure to read the IFU negated proximate case, the court proceeded to analyze two versions of the failure to warn claims focused on the prescribing physician.

As to claims based on the IFU, summary judgment was granted because the prescriber did not read or rely on it.  Id. at *8.  Plaintiff’s reference to the sort of testimony often adduced—that the doctor relies on a “pool of information”—did not change the result because the testimony did not indicate the IFU she had not read was part of that pool.  Id.  Curiously, though, there was second theory based on the disclosure of risks in the patient brochure.  Based on testimony that the doctor “that she typically discussed the information in the brochure as well as the risks identified therein with her patients,” the court found a genuine issue on causation.  Id.  We are confused by this.  There was no evidence the doctor relied on a brochure written for patients for her understanding of the risks, let alone that she would have done something different in connection with the surgery with this patient.  It makes no sense that a doctor who did not read the IFU would rely on a patient brochure to make a decision on which device to use or surgery to do.  Even if there were some evidence that she would have engaged in a different discussion with plaintiff based on what the patient brochure said, the better thinking does not allow proximate cause for a claim based on a failure to warn the doctor to be based on speculative testimony about what the patient (now plaintiff) would have done with a somewhat different oral consent from the doctor.  Here, the jury would be asked to decide this issue based on the plaintiff’s self-serving testimony about how she would have done something different based on the possibility that different words might have been used in an oral conversation a dozen years earlier.  That would undercut much of the public policy the court found persuasive in predicting the adoption of the learned intermediary doctrine.  Because Vermont’s learned intermediary law is nascent, we will cut the court some slack.  In the future, this is the sort of record that should result in summary judgment on all warnings-based claims.

 

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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