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At this point, let’s call it what it is: anti-social distancing.  The second word follows much better from that first word.  They go together.  Always have.  It gives you the right mindset too.  When you go for a perilous walk around the block, and you see someone doing the same thing, and they start coming too close to you: “Get the **** away from me.”  Voila, distancing.  Anti-social distancing.  It works.  Then you go back inside.  The same people are there, and you head back into your tiny office and find some work to do.  You get back up, go get a little too much to eat and return to your tiny office.  You talk on the phone or stare at grids of videos on your screen.  From your tiny office.  It’s all so anti-social and distant.  It’d be nice to have immunity from this thing.  At least you’d lose the worrying, but you probably wouldn’t lose the distancing that everybody else would still practice on you.  Ah, well.

The defendants had immunity in Sharp v. Ethicon, Inc., 2020 WL 1434566 (W.D. Ark. Mar. 24, 2020), or at least something very like it.  Its name was Dr. Crownover.  The defendants didn’t even need a warning with him.  Adequate or inadequate, he took care of it.

The plaintiff had complications from her pelvic mesh surgery.  Her surgeon was Dr. Crownover.  After remand back to Arkansas (source of the applicable law), plaintiff simply surrendered over a dozen claims on her MDL short-form complaint that probably never should have been there, all that was left for defendants to seek summary judgment against was plaintiff’s failure to warn claim.  Id. at *1.  Plaintiff claimed that the warnings in the instructions for use were inadequate.

Dr. Crownover basically gave defendants immunity.  He knew that the pelvic mesh product, called a TVT-O device, had a wide range of potential complication that could be mild, moderate or severe:

[Dr. Crownover] was aware—both at the time of his deposition and at the time of Ms. Sharp’s surgery in 2010—that there were certain risks associated with the TVT-O device, including wound complications, fistula formation, inflammation, neuromuscular problems, the need for one or more surgeries to treat an adverse event, the possible recurrence of the underlying medical condition or the failure of the device, erosion/exposure/extrusion of the mesh, and contraction of the tissues.  He agreed that all of these complications could be “mild, moderate, or severe.”

Id. at *4.  While he likely read the instructions for use, he didn’t rely on them.  He relied on his own training and experience and the medical literature.  Id.  Dr. Crownover then landed the haymaker.  Even the additional warning plaintiff was seeking would not have changed his decision to prescribe the TVT-O device:

Q If Ethicon had included in the TVT IFUs the words found under the mesh column in Exhibit No. 8, is it correct to say that those additional words being added to the IFUs would not have changed your decision to prescribe the TVT-O for Ms. Sharp?

A They would not have influenced whether I offered that or not.

Id.

There goes but-for causation and proximate causation.  The court granted summary judgment.  Id. at *4-5.  The learned intermediary doctrine works so well when the doctor is, in fact, learned.

OK, I’m now going to post this thing on the website for you.  Then to the refrigerator.  Then back to the tiny office.  Ah, well.

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We’ve blogged several times before how the logic of the United States Supreme Court’s decision in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), dooms nationwide class actions against corporations – except in jurisdictions where they are “at home.”  BMS held, essentially, that a non-resident plaintiff could not sue a non-resident corporate defendant over injuries that did not occur in the forum – and that the presence of other, resident plaintiffs asserting the same claims didn’t create personal jurisdiction that otherwise wouldn’t exist.  “In order for a state court to exercise specific jurisdiction, the suit must arise out of or relate to the defendant’s contacts with the forum,” so that “there must be an affiliation between the forum and the underlying controversy, principally, an activity or an occurrence that takes place in the forum State and is therefore subject to the State’s regulation.”  Id. at 1780; see also Id. at 1781 (lack of specific jurisdiction “remains true even when third parties (here, the plaintiffs who reside in California) can bring claims similar to those brought by the nonresidents”); 1783 (personal jurisdiction requirements “must be met as to each defendant over whom a state court exercises jurisdiction”; the “bare fact” that defendant has a “contract[] with” an in-state resident “is not enough”).

But that is exactly what any multi-state class action against a non-resident corporation necessarily does, since a large number of putative class members will necessarily be non-residents as well – with no injuries, and indeed no contact at all, with the forum jurisdiction.

BMS did not involve class actions, but the Court was well aware of the potential impact its ruling might have on purported nationwide classes, since this eventuality was mentioned in Justice Sotomayor’s lone dissent.  Id. at 1789 n.4 (BMS “does not confront the question whether its opinion here would also apply to a class action in which a plaintiff injured in the forum State seeks to represent a nationwide class of plaintiffs, not all of whom were injured there”).

The class action plaintiffs’ bar – their business model being threatened by BMS – launched a furious counter attack, claiming “we’ve always done it this way,” unnamed class members don’t count, and that class actions are different from other types of litigation.  We’ve rebutted these arguments at length in our prior posts and won’t go into them in any detail here.  A three sentence thumbnail:  One:  For decades before Daimler AG v. Bauman, 571 U.S. 117 (2014), everyone thought “continuous and substantial” business supported general jurisdiction – “always done it this way” doesn’t defeat due process.  Two:  The Rules Enabling Act precludes Rule 23 from creating personal jurisdiction for a claim where, without the class action mechanism, it would not exist.  Three:  Fed. R. Civ. P. 82 explicitly provides that the rules of civil procedure “do not extend or limit the jurisdiction of the district courts or the venue of actions in those courts.”

But unfortunately, it looks like this personal jurisdiction issue is going to require the Supreme Court, once again, to pick up that two-by-four, and beat the lower courts into compliance with due process as construed in BMS and Bauman.

Two courts of appeals recently looked at that question.  The Seventh Circuit, in Mussat v. IQVIA, Inc., ___ F.3d ___, 2020 WL 1161166 (7th Cir. March 11, 2020), succumbed to the “we don’t wanna change, and you can’t make us” mantra of the plaintiffs’ class action bar:  “Decades of case law show that this has not been the practice of the federal courts.”  Id. at *3.  Defendant “urges a major change in the law of personal jurisdiction and class actions.”  Id. at *5.  Mussat goes on to cite several decisions that ignore absent class members with respect to diversity jurisdiction and venue.  Id. at *4.  But Mussat ignores a critical difference.  Those cases all involved statutes:  28 U.S.C. §1332, 28 U.S.C. §1367 (jurisdiction), and 49 U.S.C. §16(4) (venue under the Interstate Commerce Act).  Mussat, however, construes nothing but Rule 23 – and Rule 23 cannot change the substantive rights of the parties or the substantive requirements of constitutional law.  The same goes for Fed. R. Civ. P. 4, which Mussat attempts to draft into the expansion of personal jurisdiction for class actions.  2020 WL 1161166, at *5.

We continue to believe that all litigants are entitled to the same due process, and that due process (whether under the 5th or 14th Amendments) applies in the same way to defendants in all litigation – individual (Walden v. Fiore, 571 U.S. 277 (2014)), mass action (BMS), or class actions.  No Federal Rule of Civil Procedure can change the stark fact that, if Plaintiff A can’t get personal jurisdiction over Defendant B in Jurisdiction C, then an entire class of Plaintiff As can’t use Rule 23 to sue Defendant B in Jurisdiction C for the exact same thing.  Due process, the Rules Enabling Act, and the Federal Rules themselves all forbid it.  See Tyson Foods, Inc. v. Bouaphakeo, 136 S. Ct. 1036, 1048 (2016) (a court “violate[s] the Rules Enabling Act by giving plaintiffs and defendants different rights in a class proceeding than they could have asserted in an individual action”).

In the second decision, the District of Columbia Circuit decided to punt.  Molock v. Whole Foods Market Group., Inc., ___ F.3d ___, 2020 WL 1146733 (D.C. Cir. March 10, 2020).  The class plaintiffs in Molock took the extreme position that “[Rule] 23 permits a federal court sitting in diversity to exercise personal jurisdiction over unnamed, nonresident class members’ claims, even if a state court could not.”  Id. at *2.  That, of course, directly implicated the Rules Enabling Act and Rule 82.

Rather than apply BMS to class actions, a 2-1 panel majority in Molock found prematurity, even though plaintiffs had never raised that issue in the district court:

It is class certification that brings unnamed class members into the action and triggers due process limitations on a court’s exercise of personal jurisdiction over their claims.  Any decision purporting to dismiss putative class members before that point would be purely advisory. . . .  Motions to dismiss nonparties for lack of personal jurisdiction are thus premature. . . .  Because the class in this case has yet to be certified, [defendant’s] motion to dismiss the putative class members is premature.

2020 WL 1146733, at *3 (citations omitted).  According to Molock, only after class certification may a defendant challenge a court’s personal jurisdiction over absent class member.  Id. (“Only after the putative class members are added to the action − that is, when the action is certified . . . − should the district court entertain [defendant’s] motion to dismiss the nonnamed class members.”).  Molock thus requires class action defendants to sacrifice themselves to the prospect of massive classwide liability in order to assert their due process rights under BMS.  That is ironic in the extreme, since:

In determining whether personal jurisdiction is present . . . the “primary concern” is “the burden on the defendant.”

BMS, 137 S. Ct. at 1780 (quoting World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 292 (1980)).

The dissent in Molock recognized that the prematurity argument was ridiculous.  “[A] hypothetical named plaintiff would be entitled to extensive class discovery even after an on-point decision by the Supreme Court concluding, as I do, that the principles in [BMS] extend to class actions.”  2020 WL 1146733, at *8 (Silberman, J., dissenting).  And the dissent got the merits right, too:

[F]or the question at hand, the party status of absent class members seems to me to be irrelevant.  The Court’s focus in [BMS] was on whether limits on personal jurisdiction protect a defendant from out-of-state claims, and a defendant is subject to such claims in a nationwide class action as well.  A court’s assertion of jurisdiction over a defendant exposes it to that court’s coercive power, so such an assertion must comport with due process of law.  A court that adjudicates claims asserted on behalf of others in a class action exercises coercive power over a defendant just as much as when it adjudicates claims of named plaintiffs in a mass action. . . .  And much like the class action mechanism cannot circumvent the requirements of Article III, it is not a license for courts to enter judgments on claims over which they have no power.  A defendant is therefore entitled to due process protections − including limits on assertions of personal jurisdiction − with respect to all claims in a class action for which a judgment is sought.

Id. at *10 (citations and footnote omitted).  Even if Congress could, by statute, authorize nationwide class actions under state law “Congress has done no such thing.”  Id. at *11.

[T]he limits that do follow from applying [BMS] to class actions in federal court are no different from the limits that apply when individual plaintiffs sue on their own behalf, and that must be tolerated under current law.  For example, it is true that plaintiffs likely would be unable to bring a unitary nationwide class action against two or more defendants who are subject to general jurisdiction in different states. . . .  But similarly an individual plaintiff − not a class action − ordinarily cannot bring these sorts of defendants into a court to answer to claims that have nothing to do with the forum.  And procedural tools like class actions and mass actions are not an exception to ordinary principles of personal jurisdiction.

Id. (citations omitted) (emphasis added).

Nuff said.  Take it to the Supreme Court.

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Last week we discussed the Jacob v. Mentor Worldwide, LLC case, in which a pro se plaintiff alleged injuries from breast implants and complained that the manufacturer had inadequately warned of the risks. The claim boiled down to an attack on the FDA-approved labeling of a class III medical device, and that meant it was preempted. The court dismissed the case in its entirety, but gave leave to amend. We said we awaited the outcome of further proceedings.

Well, that was dim-witted of us. The opinion we blogged about was from last July. Any decent associate would have Shepardized the case and learned that the plaintiff had, in fact, amended the complaint, and the court did, in fact, dismiss it yet again. (That happened on December 10, 2019.) But in our self-quarantined, self-pitying, terrified news-watching, ice cream-eating state, we dropped the ball. Luckily, the attentive, diligent, victorious, omnicompetent defense counsel folks at Tucker Ellis filled us in on what the medical experts would call the sequelae.

The plaintiff, still acting pro se (you can see where this is going, right?), amended the complaint to allege claims of violation of premarket approval, breach of implied warranty, and lack of informed consent (failure to warn) against the manufacturer. But the pro se doctor plaintiff did not stop there. She also alleged a medical malpractice claim against her doctor, as well as claims against the American Society of Plastic and Reconstructive Surgeons (ASPRS) and the FDA.

Let’s start with the new defendants. The medical malpractice claim was barred by Florida’s medical-negligence four year statute of repose. That four year period precludes lawsuits against medical providers no matter when the plaintiff discovered the alleged negligence. Moreover, the plaintiff had not complied with the pre-lawsuit screening process that Florida requires (as do many other jurisdictions) plaintiffs to go through prior to filing a lawsuit. All of that is just another example of doctors getting much more favorable legal treatment than the smart and kind people who invent the products that allow doctors to do what they do. One would have thought that the pro se plaintiff, who was a doctor herself, might have been aware of these procedural hurdles. But we digress. The cause of action against the ASPRS failed because there was no privity between the plaintiff and that organization, nor was there any causal nexus in sight between the ASPRS and the plaintiff’s injuries. As for the claim against the FDA, there are two words that slam the door shut: sovereign immunity.

The amended claims against the manufacturer weren’t really so amended. The court held that the amendments did “not satisfy the Court’s July 17, 2019 order,” “failed to cure the deficiencies,” and were merely an attempt “to repackage the previously preempted claims.” The ‘new’ claims, at bottom, were still gripes about a failure to warn. That sorry sameness again banged against Riegel and Buckman preemption. This time the court dismissed the case with prejudice.

So at least when we likened the plaintiff to Sisyphus, we weren’t wrong. She pushed the rock, the amended complaint, up a hill, and it rolled right back down. Now we have learned that the plaintiff has filed an appeal with the Eleventh Circuit. It looks to us like yet another push of the rock up the hill.

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Almost two months ago we posted on the magistrate’s Report and Recommendation in Drescher v. Bracco Diagnostics Inc., 2020 WL 699878 (D. Ariz. Jan. 31, 2020).  Back when our co-workers didn’t include furry, four-legged friends.  When we weren’t also re-learning high school geometry.  And when pajamas and slippers weren’t acceptable work attire.  Many things have definitely changed.  Fortunately, the result of Drescher isn’t one of them.

Following the magistrate’s dismissal of all claims, over plaintiff’s objections, the court adopted the magistrate’s findings in full and authored a thoughtful opinion of its own.  Drescher v. Bracco Diagnostics Inc., 2020 WL 1466296 (D. Ariz. Mar. 26, 2020).  As a reminder, plaintiff underwent MRIs in 2013, 2015, and 2016 before each of which she was injected with a linear gadolinium-based contrast agent (GBCA) manufactured by defendants.  Plaintiff had normal kidney function at the time of her GBCA injections.  She alleges that she has retained gadolinium in her organs that is causing fibrosis and related symptomology.  Plaintiff brought causes of action for failure to warn and defective design under both negligence and strict liability.  Id. at *1-2.  Plaintiff raised three objections to the magistrate’s recommendation.

First, plaintiff claimed that the magistrate did not draw all reasonable inferences in her favor.    But plaintiff failed to identify what those inferences should have been.  Id. at *4.  That’s because plaintiff only made conclusory causation allegations that not only weren’t supported by the facts, but were actually contradicted by them:

Rather, the information provided by Plaintiff shows that the FDA found, after inquiry and studies, that it could not establish a causal association between adverse health effects reported by patients with normal kidney function and gadolinium retention.

Id.  Because plaintiff’s allegations were merely speculative or not facially plausible, the magistrate correctly applied the TwIqbal standard in dismissing the case.

Second, plaintiff took issue with the magistrate’s finding that the FDA found no causal nexus between GBCA and adverse health effects in patients with normal kidney function.  Id.  Plaintiff argued that FDA’s 2018 label change was “reasonable evidence” of a causal association.  But the label change stated:  “adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.”  Id. at *5.    Essentially, plaintiff was asking the court to overlook the FDA’s findings and “to draw an inference that is both unsupported and explicitly contradicted by the record before it.”  Id.  The court was unwilling to do so.

Finally, plaintiff argued that the magistrate erred in finding that her design defect claim was barred by Restatement (Third) of Torts §6(c).  The court begins its analysis by addressing what plaintiff failed to – that her design defect claim was also dismissed as preempted.  The court agreed with the magistrate that a design defect claim would require defendant to alter the formulation of its product, something not allowed without FDA approval.  Id.   Plaintiff’s argument that defendant should have sold a different type of GBCA, or stopped selling its GBCA, was also preempted under Mutual Pharm Co., Inc. v. Bartlett, 570 U.S. 472, 488 (2013).

The court then turned to §6(c) and its requirement that defendant’s “duties with respect to product design apply only to foreseeable risks of harm.”  Id. at *6.  Based on the record provided by plaintiffs, the court was unable to draw an inference that the risks of GBCAs to patients with normal kidney function were foreseeable given the FDA’s findings.  Id.

So, the court adopted the magistrate’s report and recommendation in full.  We emphasize that because the magistrate’s report ended with an admonishment to plaintiff that she should only file an amendment complaint if she had additional factual support for at least one claim.  We hope plaintiff takes that part to heart.  We don’t think any more time or resources should be spent turning this into a trilogy.

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When times are tough, attempted humor can fall flat. Opinions often add little. Fancy prose and witty turns of phrase count for little. Facts, for those whose preconceived notions allow them to be received as such, matter. The language of statutes—potentially powerful drivers of needed stability or change—should be easy to understand even without reference to additional documents on legislative intent (let alone any resort to purported executive intent). With that preface, we will keep simple and play it straight.

We have been writing about cases involving the Ohio Product Liability Act (“OPLA”) for a long time.  See, e.g.,  here , here, here, and here.  We have been litigating cases involving the OPLA even longer.  One of the main issues that used to come up was how the OPLA preempted common law. There was a period when the date that a case was filed affected what was and was not abrogated by the OPLA, which was certainly intended to provide a statutory framework for products liability claims under Ohio law, replete with limits on punitive damages and other protective provisions that a state with resident companies that manufactured products wanted. The common law, on the other hand, had been made by judges over the course of decades and tended to provide enough leeway for expansive applications of negligence and fraud in particular cases. In 2005, the OPLA was revised to make its abrogative effect clear, overruling a 1997 Ohio Supreme Court case. Old news, but it still keeps coming up.

Similarly, there are still new pelvic mesh cases being filed and, for a while now, most of the ones with diversity have not had to work their way through an MDL to get before a local federal court. Sylvester v. Ethicon, Inc., No. 1:19CV2658, 2020 U.S. Dist. LEXIS 47467 (N.D. Ohio. Mar. 19, 2020), is one such case. (From the information in the court’s opinion, it also looks to be old in the sense of time-barred, with a 2012 explant and a 2019 filing date.) It started out with a “standard” eighteen count (with fifteen claims plus loss of consortium, punitive damages, and an anti-SOL count) complaint asserting a variety of statutory and common law claims. For some reason, however, when it came time to oppose the motion for summary judgment on almost all of the counts, plaintiff decided to drop all but one of her claims under the OPLA and urge that her common law claims for negligence, fraud, and express warranty were viable. Because abrogation turns on the pleadings rather than the evidence adduced in discovery, this tactic turned the summary judgment analysis into a straight legal one.

The OPLA defines a “Product liability claim” as one that

that seeks to recover compensatory damages from a manufacturer or supplier for death, physical injury to person, emotional distress, or physical damage to property other than the product in question, that allegedly arose from any of the following:

(a) The design, formulation, production, construction, creation, assembly, rebuilding, testing, or marketing of that product;

(b) Any warning or instruction, or lack of warning or instruction, associated with that product;

(c) Any failure of that product to conform to any relevant representation or warranty.

Id.at **5-6 (quoting Ohio Rev. Code Ann. § 2307.71(A)(13)). Reviewing the multiple allegations that flowed into the four negligence-based counts and three fraud-based counts, it was apparent that they each hinged on several of these categories of conduct. The court patiently went through the allegations for these seven counts and dismissed each of them. Id. at **10-15.

Express warranty was a bit trickier because of the redundancy of plaintiff’s pleading. Plaintiff’s claims that “the pelvic mesh was not fit for use by consumers nor was it of merchantable quality” were covered by the plain language of subjection (c) above and, therefore, her common law claim for express warranty was abrogated. Id. at **12-13. However, the pleading was read as broad enough to allege a warranty claim under the Uniform Commercial Code, which is not abrogated (but does not allow personal injury damages). Id. at *13.

The last contested claim, unjust enrichment, was easier. Plaintiff alleged that she “did not receive the safe and effective medical devise [sic] for which [she] paid,” which “implicates the pelvic mesh’s failure to conform to a relevant representation and/or its marketing” under subjection (c). Id. at *5. Abrogation of this claim left plaintiff with one (unchallenged) claim under O.R.C. § 2307.75, which does not really provide a pure strict liability design defect remedy as set out in some of the posts linked above.

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Today’s guest post is by Corinne Fierro, Mildred Segura, and Farah Tabibkhoei, all of Reed Smith.  These three are all part of the firm’s left-coast, techno side of the product liability practice, and bring our readers a recent appellate decision that addresses the intersection of 21st Century high technology and 20th Century product liability concepts.  As always, our guest bloggers deserve all the credit (and any blame) for what follows.

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Is an Artificial Intelligence (“AI”) algorithm subject to strict liability principles? For years, this question has gone unanswered by courts.  Now, it would seem that the courts’ long-awaited discussion on this topic has begun as T.S. Elliot predicted it all would end: “not with a bang but with a whimper.”

On March 5, 2020, the Court of Appeals for the Third Circuit held in Rodgers v. Christie that an algorithmic pretrial risk assessment, which uses a “multifactor risk estimation model,” to assess whether a criminal defendant should be released pending trial , was not a “product” under the New Jersey Products Liability Act (“NJPLA” or “the Act”).  2020 WL 1079233, at *2 (3d Cir. 2020).  This is not a life sciences case, but is important because it’s an indication of how the product liability framework may be applied to AI’s applications including, but not limited to, medical and pharmaceuticals.  You may recall this Blog’s past blog post, which theorized about how an AI product liability case could play out.  Although the Third Circuit’s Rodgers decision is not binding precedent, it is a start to what we believe will be a growing body of case law regarding AI in the product liability context.

Let’s dive in.

In Rodgers, Plaintiff brought a product liability action under the NJPLA after her son was murdered, allegedly by a man who had been granted pretrial release from jail just days earlier − after the state court used the Public Safety Assessment (“the PSA”).  Id. at **1-2.  The PSA is an algorithm developed by the Laura and John Arnold Foundation (the “Foundation”) to estimate a criminal defendant’s risk of fleeing or endangering the community.  Id. at *3.  Plaintiff sued the Foundation, and miscellaneous individuals not involved in this appeal.

The Court affirmed the district court’s dismissal of the complaint finding the PSA is not a product under the NJPLA.  The district court applied the NJPLA, which imposes strict liability on manufacturers or sellers of defective “products.”  Id. at *2.  The NJPLA does not define the term “product,” so the court turned to the Restatement (Third) of Torts.  Under the Restatement, a “product” is “tangible personal property distributed commercially for use or consumption” or any “[o]ther item[]” whose “context of . . . distribution and use is sufficiently analogous to [that] of tangible personal property.”  Id.

Applying this definition, the district court held the PSA does not qualify as a “product” under the Act, and therefore could not be subject to strict liability.  The Third Circuit affirmed this decision for two reasons: 1) the PSA is not distributed commercially; and 2) the PSA is not “tangible personal property nor remotely analogous to it.”  Id. at *3 (internal quotations removed).

As to the first point, the Third Circuit agreed with the district court that the PSA was not commercially distributed but rather designed as an “objective, standardized and . . . empirical risk assessment instrument” to be used in pretrial services programs.  Id. (internal quotations removed).

Second, the Third Circuit affirmed the district court’s reasoning that the PSA could not qualify as a “product” because “information, guidance, ideas, and recommendations” cannot be products under the Third Restatement.  Id. (internal quotations removed).

In addition to this definitional exclusion, the district court also was hesitant to impose strict liability because “extending strict liability to the distribution of ideas would raise serious First Amendment concerns.”  Id.  This reasoning, which has previously been applied to a variety of product liability cases involving books and media, could apply to AI more generally, given that AI algorithms are used most commonly now to render recommendations and guidance.  In healthcare, AI algorithms are used to diagnose patients with various diseases such as diabetic retinopathy and cancer.  They help patients monitor their health via “smart” insulin pumps and phone applications.  The role AI plays in these scenarios, however, is suggestive.  AI proposes its idea in the form of a diagnosis, or application alert, and human beings act upon that information.  The First Amendment defense would, by extension, likely apply to these algorithms.

Plaintiff attempted to sidestep the “product” definition, and argued that PSA’s defects “undermine[] New Jersey’s pretrial release system, making it not reasonably fit, suitable or safe for its intended use.”  Id. at *4 (internal quotations omitted).  The Third Circuit affirmed the lower’s court dismissal of this argument, noting that the NJPLA only applies to defective products, “not to anything that causes harm or fails to achieve its purpose.”  Id.

So what does this case mean for defendants facing AI product liability claims?  First, if the Third Circuit’s decision is any indication, courts are likely to apply traditional product liability principles to AI and find that AI is not a “product” within the meaning of the Restatement (Third) of Torts.  Second, courts following Rodgers are likely to hold that AI is not subject to strict liability claims.  Third, we expect the holding in Rodgers will not open the floodgates to AI litigation, for now, because plaintiffs will likely face an uphill battle in establishing that strict liability applies.  And finally, a First Amendment challenge stands in the way for plaintiffs seeking to extend strict liability to algorithms.

While this case is not binding precedent, it is hopefully the start of broader court engagement on the topic.  We’re hoping for a bang.

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The Pennsylvania Supreme Court entered an emergency COVID-19-related order on March 24, 2020 – copy here – that should be of interest to our clients who engage in removal before service (so-called “snap removal”).  As we reported at the time, the Third Circuit upheld removal before service in Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., 902 F.3d 147 (3d Cir. 2018), which means many of our clients are no doubt monitoring the electronic dockets of various Pennsylvania courts of common pleas for new filings.

For the duration of the COVID-19 emergency, there’s now someplace else that our clients need to monitor – the Superior Court of Pennsylvania.  As provided by the Pennsylvania Supreme Court’s order:

In the event a court of common pleas is unable to accommodate the filing of a praecipe for a writ of summons, attorneys may file a praecipe for a writ of summons in the Superior Court district corresponding to the applicable court of common pleas, pursuant to the miscellaneous filing procedure set forth in the Superior Court’s Order dated March 23, 2020, Superior Court Administrative Docket No. 3.  The filing in the Superior Court must be accompanied by the filing attorney’s certification that the attorney has been unable to file the praecipe in the appropriate court of common pleas due to the closure of that court to such filings in light of the ongoing public health emergency, and that in the attorney’s opinion, filing of the praecipe for a writ of summons is necessary to toll a statute of limitations that would otherwise expire during the judicial emergency declared by this Court, or any extension of that judicial emergency.

(Emphasis added).

We have two observations.  First, in order to track new filings, clients will now need also to monitor activity on the Pennsylvania Superior Court’s docket.  We don’t know exactly how to do that on an ongoing basis, but the vendors currently providing such services should.  All we know is that Superior Court dockets are publicly available through this link.  Change the default “search type” to “court name,” then choose “Superior Court,” and search that court’s electronic docket by party name.

Second, the Supreme Court has specified what has to be included in the attorney certifications authorized under its order:  (1) inability to file, and (2) that the filing is necessary to toll an imminently expiring statute of limitations.  Clients should therefore examine all such filings against them for compliance with the Supreme Court’s order, because an insufficient attorney certification should fail to toll the statute of limitations, providing grounds later to seek dismissal.

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No writer made as strong an impression on us in high school as Albert Camus. The opening of The Stranger is arresting: “Mother died today. Or maybe it was yesterday, I don’t know.” Our teacher pronounced The Plague to be an even better book, and he often quoted the bit about how we had “to be content to live only for the day, alone under the vast indifference of the sky.” [One of our time entries for yesterday is very similar.] Now, in the days of the coronavirus, it is hard not to bump into borrowed lines from The Plague, especially this one: “There are more things to admire in men than despise.” Perhaps Camus would rethink that after wandering down supermarket aisles denuded of toilet paper.

Camus has put us in the mood for absurdity, so let’s take a look at a pro se product liability lawsuit attempting to squeeze into the overused, incoherent, narrow-gap, Riegel “parallel claim” exception. In Jacob v. Mentor Worldwide, LLC, 2019 WL 3229010 (M.D. Fla. July 17, 2019), the plaintiff alleged that a breast implant ruptured and caused her to suffer from a “lupus-like syndrome.” The plaintiff had an M.D. after her name, but we don’t know what sort of doctor she was. What we do know is that she wasn’t much of a lawyer and, as the saying goes, had a fool for a client. The complaint included causes of action for negligence, failure to warn (of the foreign country origin and of the risk of failure), and manufacturing defect. The defendant, represented by actual lawyers, moved to dismiss on the grounds of express and implied preemption.

In responding to the motion, the plaintiff argued that she was adversely affected by the implants, that, as a doctor, she could attest to the harm she suffered, that the implants were unduly porous, and that the defendant’s failure to disclose the risk of syndromes mimicking connective tissues disease led to a misdiagnosis of her condition. What does any of that have to do with preemption? Not a thing. That made life easy for the court: “Defendant is correct that Plaintiff’s claims are the extent that Plaintiff is seeking to recover for Defendant’s alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA. Similarly, Defendant is correct that Plaintiff’s claims are preempted to the extent that Plaintiff is seeking to enforce federal requirements that are not grounded in traditional state tort law.”

The problem for the plaintiff is that all her claims fell into those preempted categories. Her claims talk about failures to warn the public, doctors, and the FDA (can you say Buckman?) and, most obviously preempted of all, failures to “revise the product labeling” and communicate the “true rate” of adverse events.

Moreover, the court was irked by the plaintiff’s wholesale failure to comply with the Federal Rules of Civil Procedure. Rule 8 insists on “short and plain” statements of jurisdictional bases and substantive claims. Each allegation must be “simple, concise, and direct.” Apparently, the plaintiff’s prose flunked these requirements. (She should have read Camus – talk about simple, concise, and direct!). Rule 10 requires numbered paragraphs, and the plaintiff did not even get that right.

The court gave the plaintiff 28 days to amend her complaint, but ordered that any claim that “seeks to recover for Defendant’s alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA, or seeks to enforce federal requirements that are not grounded in traditional state-tort law,” is dismissed with prejudice.

So the plaintiff was free to try again. That possibility puts us in mind of another work by Camus, The Rebel. The central image of that work (a philosophical investigation, not a novel) is the myth of Sisyphus.

In the meantime, we’ll leave you with another quote from The Plague: “What’s true of all the evils in the world is true of plague as well. It helps men to rise above themselves.”

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Isn’t enough for standing that is.  And, likely not enough for plaintiff’s case to survive, but that question was left for another day.  We’ve done a few posts on “slack fill” which is defined by the FDA as the difference between the capacity of a container and the volume of product inside.  Slack fill lawsuits have been filed against food and beverage makers, and OTC drug manufacturers, who leave empty space in a container.  The reasons for such empty space could be, for example, to protect the contents or to comply with shipping requirements.  But slack fill is acceptable so long as the container or packaging is not misleading – it contains the quantity, the product weight, the number of servings, etc.

Today’s case is similar to a slack fill case, but also sort of the opposite.  Instead of empty space being the issue, too much product is what the plaintiff in Williamson v. Genentech, Inc., 2020 WL 1281532 (N.D. Cal. Mar. 18, 2020) was complaining about.  Not slack fill but excess fill.  The problem was, he really didn’t have a problem.

Plaintiff was diagnosed with follicular lymphoma and prescribed a medication that was sold in single use vials.  For each round of treatment, plaintiff was prescribed approximately 770 to 780 milligrams of the drug.  Defendant manufactured the drug in 100 mg and 500 mg vials.  So, for each treatment, the hospital had to use a combination of vials totaling 800 mgs, meaning that there were 20-30 mgs that plaintiff did not receive – wasted medication.  Id. at *1.

Plaintiff filed a purported class action alleging that the vials sold by defendant resulted in wasted medication and therefore violated California’s Unfair Competition Law (“UCL”) because class members were forced to purchase more medication than they could use.  Id. at *2.  The case was removed to federal court the Class Action Fairness Act (“CAFA”).  After which, the court sua sponte raised the question of whether it had subject matter jurisdiction – or phrased differently, whether plaintiff had Article III standing to bring his claim.  The court’s concern was whether plaintiff had alleged an injury in fact.  For standing, an injury in fact must be “particularized and concrete,” not “conjectural or hypothetical.”  Id. at *2.  The court also noted that the UCL similarly requires a plaintiff to “allege that he has suffered injury in fact and has lost money or property as a result of a violation.”  Id.

The only out-of-pocket cost to the plaintiff for his treatments was a single payment of $231.15 in March 2017.  But nowhere in his complaint did plaintiff allege that his payment would have been different (less) if the amount of wasted medication was less.  In fact, in his briefing on subject matter jurisdiction, plaintiff clarified that the payment was actually the remaining amount of his insurance deductible and was not tied to the cost of the medication at all and would not have been different if less medicine was dispensed.  Id. at *3.  Therefore, plaintiff had no factual support for his allegation of financial injury.

Instead, plaintiff argued that he could establish standing based on California’s collateral source rule.  Under the collateral source rule, a defendant’s liability for a plaintiff’s financial damages is not reduced by any payments that the plaintiff receives as to those very same damages from a third-party source. This happens most often in connection with a plaintiff’s medical bills.  While the plaintiff’s insurance pays all or most of those bills, the defendant remains liable to plaintiff for the entire amount.  Clearly not a defense favorite as it runs counter to a core purpose of tort law, which is to compensate plaintiffs for damages actually suffered.  So the plaintiff gets a double recovery—once from the collateral source and once from the defendant.

Plaintiff here tried to take this one step further.  His argument was that the collateral source rule allowed him “to recover the entire amount his insurance company paid on his behalf for wasted medicine due to the absence of a smaller vial size.”  Id. at *4.  But the court looked at what the UCL requires for a claim of restitution –

A restitution order against a defendant [ ] requires both that money or property have been lost by a plaintiff, on the one hand, and that it have been acquired by a defendant, on the other.

Id. (citation omitted, emphasis in original).   By definition, restitution is designed to return the status quo.  To return to plaintiff something that he owned that defendant took by means of unfair competition.  Here plaintiff isn’t out anything, by his own admission.  So there is nothing to be returned.  “The collateral source rule does not allow Plaintiff to recover as restitution monies his insurance company paid on his behalf.”  Id. at *5.

In each case cited by plaintiff, the plaintiff had sustained an injury (i.e. stolen art, damage boat) for which he was insured and received compensation from the insurance company.  But none of those cases helped plaintiff here.  First, none concerned Article III standing.  Second, in each the plaintiff was able to allege he suffered the damages for which recovery was sought.  In Williamson, however, plaintiff’s only possible injury was being forced to pay for more medicine than he needed.  But plaintiff conceded he did not in fact suffer that injury.

The rule does not apply where a person cannot plead he suffered the damages for which recovery is sought.  It is thus unsurprising that no court has used the collateral source rule to find Article III standing. This Court is not persuaded that it should be the first.

Id. at *6.

While the court’s analysis led it to conclude that it did not have subject matter jurisdiction, the same analysis should support a finding that plaintiff also doesn’t have statutory standing under the UCL.  The federal court left that question for the state court upon remand “should Mr. Williamson decide to pursue his claim.”  Id.  A word of caution perhaps?  Hopefully it is heeded.  Because sometimes too much of something isn’t a problem at all.

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The advent of generic preemption in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (“Mensing”), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (“Bartlett”), left plaintiffs who took generic drugs scrambling to invent bizarre, novel, and in some cases dangerous supposed causes of action.  Before it went under, the erstwhile metoclopramide litigation (which produced Mensing itself) generated a wave of innovator liability claims – thankfully mostly unsuccessful, and allegations concerning failure to update generic labels.  The latter was more successful in avoiding preemption but never got anywhere on the merits because it was simply an nonviable cause of action..

Another batch of plaintiffs left high and dry were those claiming injury from taking generic amiodarone.  They have tried to squirm around preemption in essentially three ways.  Theory one is that the generic manufacturers themselves promoted off-label use.  Theory two is that they failed to ensure than an FDA-mandated medication guide actually made it into the hands of patients.  Theory three is that generics benefited from the original branded manufacturer’s off-label promotion years earlier, and thus had some obligation to correct lingering misimpressions in the medical community left by that promotion.

We now count sixteen amiodarone cases in our generic preemption scorecard.  There was one hot spot in Texas that allowed some of these claims to escape preemption on the pleadings, but those cases failed on the merits when plaintiffs failed to find any evidence of any FDCA violations.  See Mitchell v. Wyeth Pharmaceuticals, Inc., 356 F. Supp.3d 634, 639 (W.D. Tex. 2018); Priest v. Sandoz, Inc., 2017 WL 7172504, at *11 (Mag. W.D. Tex. Dec. 28, 2017), adopted, 2018 WL 582532 (W.D. Tex. Jan. 17, 2018).

The other amiodarone cases have failed miserably at the outset.  What lessons can they teach us?

First, all claims that seek to change warnings concerning generic drugs, however, they’re pleaded – read, disguised – by plaintiffs are preempted.  “[W]hen the FDA has made a conclusive determination, positive or negative, as to the existence of a link between the drug at issue and some adverse health consequence, state law cannot mandate that a manufacturer include additional warnings beyond those that the FDA has determined to be appropriate to the risk.”  Frei v. Taro Pharmaceuticals U.S.A., Inc., ___ F. Supp.3d ___, 2020 WL 1165975, at *4 (S.D.N.Y. March 10, 2020) (citation and quotation marks omitted).  See also Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152, 1171 (E.D. Cal. Feb. 14, 2019) (“To the extent that these claims depend on [defendant] providing or communicating a warning that differs from the FDA approved label . . ., Mensing requires preemption and dismissal.”); Collette v. Wyeth Pharmaceuticals, Inc., 2018 WL 1258105, at *1 (N.D. Cal. March 12, 2018) (warning claims preempted; all other allegations too vague and must be repleaded); Bean v. Upsher-Smith Pharmaceuticals, Inc., 2017 WL 4348330, at *5 (D.S.C. Sept. 29, 2017) (“Defendants could not have changed the content of the warning label or Medication Guide and could not have disseminated additional warnings regarding ‘off-label’ use without violating federal law, [so] each of Plaintiff’s claims premised on Defendants’ alleged failure to warn is due to be dismissed as preempted.”), aff’d, 765 F. Appx. 934 (4th Cir. 2019).

Even of the lousiest case of the bunch, Arters v. Sandoz, Inc., 921 F. Supp.2d 813 (S.D. Ohio 2013), found warning claims, involving Dear Health Care Provider letters, preempted:

[Plaintiffs] claim that . . . defendants have a duty to warn consumers and physicians of known dangers of amiodarone in other ways.  Plaintiffs argue that defendants should have taken steps other than changing the drugs label . . . to “adequately warn healthcare providers or the FDA of all adverse event reports and all warnings mandated by the FDA.”  The plaintiffs in Mensing made a similar argument, that the generic manufacturers could have used “Dear Doctor” letters. . . .  A generic drug manufacturer who warns of risks not present in the approved label or strengthens the warning through “dear doctor” letters or other means creates labeling that is not consistent with the approved label, and is thus inconsistent with the FDCA.

Id. at 819.  See also Frei, 2020 WL 1165975, at *5 (defendant “could not have disseminated post-marketing warnings inconsistent with [branded] warnings and labeling − approved by the FDA − without violating federal law, and also could not have disseminated alternative post-marketing warnings without violating federal law, plaintiffs’ claims are preempted”); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *9 (N.D. Ala. Oct. 31, 2013) (throwing out “Dear Doctor” letter claim as “wholly preempted” under Mensing and Bartlett).  That’s lesson number one, and that’s pretty obvious.

Even if these labeling claims weren’t preempted, they have serious problems – like adequacy as a matter of law.  In Marroquin, the branded manufacturer the drug beat an unpreempted innovator liability claim on this basis:

[T]he FDA label clearly states that [the drug] is approved to treat two serious heart conditions and it is a drug of last resort because of its potentially fatal toxicities.  More than once, pulmonary toxicity is clearly and expressly identified as the most dangerous toxicity/potential side effect.  Percentages of those who experience pulmonary toxicity and the percentage of those who suffer fatal pulmonary toxicity is provided.  Importantly, there is nearly two pages of warnings/information devoted entirely to pulmonary toxicity.  These warnings are clear, do not appear to be inconspicuous, and appear to warn of the exact danger that tragically befell [the decedent].  Without elucidation from [plaintiff], the warning is adequate.

367 F. Supp.3d at 1162-63.  So lesson number two, innovator liability can be beat the same way as any other warning claim.

Arters was more indulgent of plaintiff’s off-label promotion claims, claiming – with no support whatever – that the promoted off-label use was somehow “in violation of [state] law,” 921 F. Supp.2d at 820.  Other decisions took a closer look at such claims and found them wanting.  Off-label promotion allegations were recognized as just one more form of preempted warning/design claim in a second opinion in Stephens.  Arters predated Bartlett, so since Bartlett claims that a drug was “not reasonably fit for [an] off-label purpose” were preempted as either a design defect or stop selling claim.  Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp. 3d 1246, 1250 (N.D. Ala. 2014).

Further, most courts recognize that allegations of “inadequate post-marketing instruction” about off-label use are preempted as “a classic ‘failure to warn’ claim, despite plaintiffs’ representations otherwise.”  Id. at 1251.

[T]o the extent those [off-label promotion] claims are not abandoned, they are due to be dismissed as preempted under Mensing and Bartlett because [defendant] could not have changed the content of the warning labels or Medication Guide and could not have disseminated additional warnings regarding “off-label” use without violating federal law.

McLeod v. Sandoz, Inc., 2017 WL 1196801, at *5 (D.S.C. March 31, 2017).  “[A]llegations claim that Defendants’ alleged [off-label] promotion resulted in failure to properly warn and hence are preempted by federal law.”  Connolly v. Sandoz Pharmaceuticals Corp., 2014 WL 12480025, at *6 (N.D. Ga. Dec. 23, 2014) (footnote omitted).  Further:

Plaintiffs’ claims of negligence and negligence per se based on the alleged “off-label” promotion of amiodarone are impliedly preempted under Buckman because the duties Plaintiffs allege [defendant] breached regarding “off-label” promotion exist solely under the FDCA.

McLeod, 2017 WL 1196801, at *7.  Thus, an off-label promotion claim concerning an otherwise non-defective drug is “preempted and cannot succeed as a matter of law.”  Moore v. Zydus Pharmaceuticals (USA), Inc., 277 F. Supp.3d 873, 884 (E.D. Ky. 2017).  Lesson three, use Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) (“Buckman“) to beat claims that plaintiffs crib from FDA regulations.

Eventually plaintiffs stopped claiming that the generic manufacturers themselves engaged in off-label promotion, and shifted to alleging that they had some sort of duty to correct or ameliorate the effects on the medical community of prior off-label promotion committed years earlier by the original branded manufacturer.  In Bean, this latest version of an off-label promotion claim also failed.

Plaintiff’s negligence claims based on the alleged “off-label” promotion of amiodarone are impliedly preempted under Buckman because the duties Plaintiff alleges Defendants breached regarding “off-label” promotion exist solely under the FDCA. Plaintiff has not directed the Court to any . . . state law causes of action that parallel the federal safety requirements limiting the “off-label” promotion of drugs.  Plaintiff’s claim for “off-label” promotion of amiodarone would not exist in the absence of the FDCA.  Accordingly, Plaintiff’s claim for negligence and negligence per se based on Defendants’ alleged “off-label” promotion of amiodarone . . . is impliedly preempted under Buckman and due to be dismissed.

2017 WL 4348330, at *7.  See McLeod v. Sandoz, Inc., 2018 WL 1456739, at *4 (D.S.C. March 23, 2018) (“McLeod II”) (dismissing amended complaint “for the reasons stated” in Bean).

Similarly, Frei, 2020 WL 1165975, held that any duty to “counteract” someone else’s prior off-label promotion failed.  For one thing, it was preempted.  Under Mensing there is no way a generic manufacturer could address prior off-label promotion without changing its label.  “[E]ach alleged cause of action requires [defendant] to either change the labeling for amiodarone, change its design or formation, exit the market, or accept state tort liability.”  Id. at *6 (quoting Bean).  Under Buckman “the duties [plaintiffs allege defendant] breached regarding off-label promotion exist solely under the FDCA.”  Id. (also quoting Bean).  Lesson four is not to let off-label promotion claims off the hook, since the label itself would not exist without the FDCA.

Amiodarone allegations concerning medication guides first surfaced in Stephens, which pointed out why such claims don’t work.  First, FDA “regulations require that Medication Guides be provided by a manufacturer to the distributor of a medication, not the end user.”  Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp.3d 1246, 1252 (N.D. Ala. 2014).  The manufacturer need only provide guides “in sufficient number” or the “means to produce” them to “distributors, packers, or authorized dispensers” – not end users.  21 C.F.R. §208.24(b)(1-2).  “Critically, the regulation does not obligate a manufacturer to provide medication guides directly to patients or their agents.”  Frei, 2020 WL 1165975, at *5.  See Mitchell v. Wyeth Pharmaceuticals, Inc., 356 F. Supp.3d 634, 638 (W.D. Tex. 2018) (“contrary to Plaintiff’s contention, does not place a duty upon [a manufacturer] to take steps to ensure that the Medication Guides are distributed to patients beyond providing them in ‘sufficient numbers’ to distributors, packers, and authorized dispensers”); Moore v. Zydus Pharmaceuticals (USA), Inc., 277 F. Supp.3d 873, 880 (E.D. Ky. 2017).  “[A]t the time a prescription drug is dispensed, it is the pharmacy (or authorized dispenser) that must ‘provide a Medication Guide directly to each patient,’ not the manufacturer of the drug.”  Id. (quoting regulation).  Lesson five is to study plaintiffs’ regulatory claims closely.  Usually, the FDA regulations don’t stand for what plaintiffs claim.

Second, there is no corresponding state-law duty to circulate medication guides.  Thus, a “claim for noncompliance with the federal regulation is preempted pursuant to Buckman.”  Connolly v. Sandoz Pharmaceuticals Corp., 2014 WL 12480025, at *5 (N.D. Ga. Dec. 23, 2014).  “Because the requirement to provide a Medication Guide . . . is based solely in the requirements of the FDCA . . ., and there is no parallel duty . . . under [state] law, Plaintiff’s claims based upon failure to provide a Medication Guide are preempted” under Buckman.  Bean, 2017 WL 4348330, at *7.  Time and time again, medication guide claims in amiodarone cases have fallen to Buckman preemption:

Although plaintiffs couch their failure to warn claims in traditional state tort law, it is clear the existence of the FDA’s medication guide regulation is the gravamen of these claims.  There is no question [the] amiodarone medication guide is a “critical element” in this case. . . .  Moreover, plaintiffs do not identify a parallel state law requiring [defendant] to make available to distributors an amiodarone medication guide.  And when a plaintiff’s claims “exist solely by virtue of the FDCA . . . requirements,” state law claims are impliedly preempted.

Frei, 2020 WL 1165975, at *5 (quoting Buckman).

Because the requirement to provide a Medication Guide to distributors is based solely in the requirements of the FDCA and related regulations, and there is no parallel duty to provide a Medication Guide under [state] law, Plaintiffs claims based upon failure to provide a Medication Guide are preempted under Buckman.  Stated another way, Plaintiffs’ claims against [defendant] for failure to provide a Medication Guide are preempted and due to be dismissed because the claims would not exist in the absence of the FDCA.

McLeod, 2017 WL 1196801, at *9 (citation omitted).

[Defendant’s] obligation to provide a medication guide arises solely from responsibility imposed by the FDCA. . . .  Since [plaintiff’s] claim concerning receipt of the medication guide exists exclusively due to the federal regulatory scheme, her claim must fail as the cause of action is merely based upon alleged violation of the FDCA.

Moore, 277 F. Supp.3d at 881 (citations omitted).  We’d already learned always to use Buckman, but amiodarone cases are good reinforcement of that lesson.

Frei tried to avoid preemption by claiming the same purported failures to provide medication guides as negligence per se.  Didn’t work.  Negligence per se based on FDCA requirements was Buckman preempted, since the FDCA “is not privately enforceable.”  2020 WL 1165975, at *6.  Plaintiff also asserted the same claims under New York’s “little FDCA” statute.  That gambit also failed:

In one breath, plaintiffs argue “they did not plead that any of the FDA warning[s] were inadequate,” yet in a second [they] argue [defendant] committed negligence per se by “misbranding” its product.  Moreover, and again, the FDA approved the labeling and warning information associated with [the drug], and [defendant], a generic pharmaceutical manufacturer, has on ongoing duty to provide the same warning labels.

Id. at *7 (citation omitted).  This is a reprise of lesson one – Mensing preempts all warning claims, no matter how  plaintiffs try to disguise them.

Medication guide claims in amiodarone cases also fail because they directly implicate the learned intermediary rule – that prescription medical product manufacturers are legally required to provide labels to prescribers in the medical community, and those prescribers, not manufacturers, in turn provide warnings to their patients.  Stevens, 70 F. Supp.3d at 1254 (“failure to allege [the] prescribing physician was not adequately informed about the risks . . . is fatal to plaintiffs’ claims”).  The Fourth Circuit affirmed dismissal of medication guide claims in Bean on this basis (not reaching preemption):

In this case, [the prescriber] is the learned intermediary.  As [plaintiff’s] physician he was best placed to evaluate [his] medical history and circumstances and to decide what information [plaintiff] needed to give informed consent to his treatment.  Accordingly, as long as the [the prescriber] himself. . . .

765 F. Appx. at 936 (quoting Restatement (Third) §6).  But because of Mensing, “It is uncontested that [the prescriber] received all the warnings required by federal law, and that these warnings are, on their own, adequate under state law.”  Id.  Thus,

The manufacturers made [the prescriber] aware of the risk . . . as they were required to do by federal law.  That warning was never contradicted or diluted:  There is no allegation that the manufacturers ever so much as insinuated that this risk was less severe that it really was.  The only allegation is that the manufacturers misled [the prescriber] on an unrelated issue − the benefits of [the drug] − which does not come under the scope of failure to warn liability.

Id. at 937.  Nor did the FDA’s medication guide requirement create any “exception” to the learned intermediary rule.  Id. (“Such an exception would fly in the face of the FDA’s intent that the Medication Guide rule not ‘alter the duty, or set the standard of care for manufacturers.’”) (quoting 63 Fed. Reg. 66378, 66384 (FDA Dec. 1, 1998)).

Other amiodarone decisions agree.  “[P]hysicians may and often do prescribe drugs for unapproved, off-label uses, as [plaintiff’s] physician allegedly did here.  The decision to prescribe [a drug] for an off-label use rested solely with his physician.  Within the context of prescription drugs, … [this jurisdiction] employs the learned intermediary doctrine.”  Connolly, 2014 WL 12480025, at *5.  Same result, slightly different take:

The application of the learned intermediary doctrine to Plaintiffs’ “off-label” promotion claims exposes a conceptual flaw in Plaintiffs’ case.  To avoid preemption . . ., Plaintiffs state they do not challenge the adequacy or content of the FDA approved warnings for amiodarone. . . .  Yet, in order to overcome the learned intermediary doctrine in this case, [the] prescribing physicians would essentially have to testify that they were unaware of a risk that Plaintiffs allege was adequately disclosed in the Medication Guide for amiodarone.  Critically, Plaintiffs have not alleged that the prescribing physicians did not receive the Medication Guide or were otherwise unaware of its contents.

McLeod, 2017 WL 1196801, at *10.  See McLeod II, 2018 WL 1456739, at *3 (learned intermediary rule barred claim where plaintiffs did not allege either lack of prescriber knowledge or anything else that would have “changed their decision to prescribe”).  Lesson six is that, even when a defendant has a good preemption defense, do not ignore alternative state-law grounds.

Second, a medication guide doesn’t make any difference where a plaintiff is simultaneously alleging an off-label use.  Off-label uses aren’t allowed in FDA-mandated medication guides to start with:

The plaintiffs fail to assert how the lack of a Medication Guide has any bearing on a claim of failure to warn for medication prescribed for an off-label use.  [The complaint] suggests that the plaintiffs concede the “content” of the relevant warnings were sufficient, and they seek to recover solely for the failure of decedent to receive the Medication Guide.

Stephens, 70 F. Supp.3d at 1249.  “[T]he court is struck by the inherent contradiction in plaintiffs’ allegations, specifically that they were not provided warnings for a use of [the drug] that was not within those warnings.”  Id. at 1251.  Doctors, not manufacturers, are responsible for off-label uses:

The plaintiffs fail to allege that but for defendants’ misrepresentations or suppressions about amiodarone, [decedent’s] doctor would not have prescribed this medication.  Similarly, while plaintiffs allege [the decedent was not aware that his use of the medication was for an “off-label” use, the relevant inquiry is whether his physician was aware of this.

Id. at 1252 (citation and quotation marks omitted).  Moore recognized the same problems in dismissing an express warranty case – a defendant doesn’t “expressly” warrant anything about an off-label use.  “[Plaintiff’s] use of Amiodarone . . . was ‘off-label.’  Despite her alleged reliance, the express-warranty claims are without merit because the labels never explicitly warranted that [Amiodarone] was safe for” any off-label use.  277 F. Supp.3d at 887.  Lesson seven is always to point out when a plaintiff’s claim just doesn’t make any sense.

We also spotted a couple of one-off arguments in amiodarone cases.  In Frei the plaintiff pushed a consumer fraud claim under a New York statute.  Consumer fraud has never been a good fit with the learned intermediary rule, and wasn’t in Frei:

[B]ecause a drug manufacturer’s duty to warn of a drug’s side effects runs to the doctor prescribing the drug, and not to the user of the drug, the issuance of [prescription] drug warnings . . . is not an act directed at consumers, and therefore any alleged deceptive act related to the issuance of those warnings is not a ‘consumer oriented’ act actionable under [the statute]. . . .  To state a plausible . . . claim, a plaintiff must allege that the act, practice or advertisement was consumer-oriented and misleading in a material respect, and that plaintiff was injured as a result of such conduct.

2020 WL 1165975, at *7.  That’s a repeat of an earlier lesson – pursue all state-law defenses.

Finally, one plaintiff tried to get around the problems with medication guide claims by claiming that the defendant was, in fact, a “distributor” rather than a manufacturer.  Preemption barred that claim, as well, because mere distributors have no power to alter FDA-approved labels.

Outside of the context of fraudulent joinder and removal/remand, courts have extended Mensing to entities that merely distribute prescription drugs, be they generic prescription or brand-name prescription drugs.  These cases recognize that mere distributors lack the ability to make any changes to an FDA approved label, rather only the holder of a New Drug Application (NDA) or the FDA itself can make any change to an FDA approved prescription drug label.  In this respect, a mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label.

Marroquin, 367 F. Supp.3d at 1170 (citations omitted).  That’s the last good lesson, and one that applies broadly to all prescription drug warning claims.  All distributors now have a preemption defense under Mensing/Bartlett.

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