We are trying very hard not to bore everyone silly with endless discussion of our puppy-to-be, almost certainly interesting only to us.  But we are failing.  So, briefly, we comment that we met the whole spectacular litter last week – eight gorgeous butterballs. Five are white, and three are now black but will probably end up blue – a beautiful steel gray color – according to their genetics.  Or so we are told.  We will know for sure who is coming home with us in about a week.  But it looks likely that the choice will be between a dazzling black/blue male and his equally striking white brother.  We have pictures – e-mail us!

Sadly, today’s case falls way at the other end of the pleasure spectrum from a litter of standard poodle puppies.  Back in July, Bexis blogged about a Southern District of  California decision called Whaley v. Merck & Co., 2022 WL 1153151 (S.D. Cal. April 12, 2022).  Whaley mucked up personal jurisdiction analysis by conflating it with discussion of California’s execrable innovator liability doctrine.  (As readers of this blog are aware, California is one of the few remaining states in which a plaintiff who ingested a generic version of a drug can sue the innovator – the manufacturer of the branded version of the drug – for failure to warn.  Even though the plaintiff never took that drug.  Innovator liability flies in the face of the foundational concepts underlying product liability, and we abhor it.)  Bueno, et al. v. Merck & Co., Inc., 2022 WL 4125231 (S.D. Cal. Sept. 9, 2022), was decided by the same judge who decided Whaley, and it is just as bad.  Worse, actually, because it adds a wrinkle:  it justifies its holdings by invoking the plaintiffs’ ingestion of the branded version of a drug, while the plaintiffs admit they do not know whether they took that version.   But we get ahead of ourselves.

The plaintiffs in Bueno had asthma.  They were prescribed Singulair, and, according to the complaint, their prescriptions “were filled with brand and/or generic Singulair.”  Bueno. 2022 WL 4125231 at *1 (citation to complaint omitted).  In other words, the plaintiffs admitted that they did not know whether they took the branded version, the generic version, or both.  But they adopted a shorthand throughout the rest of the complaint, alleging that they were “prescribed Singulair,” “used Singulair” and “ingested Singulair,” without the qualifying language.

The plaintiffs alleged that they“suffered neuropsychiatric injury including depression, anxiety, and suicidality,” id. (citation to complaint omitted), and that their prescribers would not have prescribed the drug for them if they knew it was associated with neuropsychiatric events.  They asserted claims for design defect, manufacturing defect, negligence, negligent misrepresentation, and breaches of express and implied warranties.   They conceded that the design defect and manufacturing defect claims should be dismissed, so the decision relates to the remaining claims.

The court began by acknowledging that the question of whether the plaintiffs ingested the branded drug or a generic version was “central to Defendant’s motion.”  The defendants disputed personal jurisdiction only if the plaintiffs ingested the generic version of the drug, and the plaintiffs conceded that their warranty claims failed if they only ingested the generic drug.  The court commented that, under Rule 12(b)(2), the plaintiffs bore the burden of demonstrating personal jurisdiction.  But, the court stated, the plaintiffs were required to make only a “prima facie showing of jurisdictional facts” to withstand dismissal.  Id. at *2.   Easy, right? Because the plaintiffs admitted that they didn’t know which version of the drug they took, so they could not “make a prima facie showing of jurisdictional facts” to demonstrate personal jurisdiction.  Right? Not according to Bueno.

Although the court acknowledged that the plaintiffs “express[ed] some uncertainty regarding whether they ingested” the branded version of the drug, it “conclude[d] that Plaintiffs [had] carried their burden to make a prima facie showing of jurisdictional facts” and rejected the defendants’ argument that the court should require the plaintiffs to produce proof of which product(s) they used before it decided the motions.  How did the court do this?  By (impermissibly) shifting the burden.  The court stated that the defendants had not “provide[d] any affidavits, declarations, or any other support for their theory that plaintiffs were prescribed” the generic drug.  And since the defendants had not “present[ed] any evidence that contest[ed] Plaintiffs’ allegations that they took” the branded drug,” the court accepted that “allegation” as true for purposes of the motion.  Even though the plaintiffs didn’t know which drug they took.  And even though it was their burden to make a “prima facie showing.”  Completely backwards, right?

It doesn’t get any better.  The court stated that the defendants were “essentially asking the court to apply a heightened pleading standard because they [were] skeptical of the Plaintiffs’ allegations.”  Id.   No, the defendants were asking the court to accept the plaintiffs’ admission that they didn’t know which version of the drug they took.  And while the court concluded that the defendants’ arguments “were best suited for a motion for summary judgment when the record [was] more fully developed,” it denied the defendants’ request to conduct limited discovery in aid of their motions. (Here is a post discussing cases in which defendants were granted jurisdictional discovery.)  Bottom line:  the court ignored the pleadings to hold that the plaintiffs sufficiently alleged that they took the branded drug, and this holding set the stage for the rest of the opinion.

Personal Jurisdiction

The defendants argued that the court lacked personal jurisdiction if the plaintiffs took the generic version of the drug.  While the court assumed, for purposes of the motion, that the plaintiffs took the branded drug, it “briefly addressed” the defendants’ argument because “fact discovery may show that the plaintiffs only ingested” the generic version.   The defendants’ argument was the same one the judge had (incorrectly) rejected in Whaley, and she refused to “revisit [that] analysis” here.  As in Whaley, the court relied on Ford Motor Co. v. Montana Eighth Judicial Dist Ct., 141 S.Ct. 1017 (2021), in which the Supreme Court held that Ford’s forum-state activities related to the same types of vehicles that injured the plaintiffs were relevant even if the allegedly-defective vehicles themselves were not “advertised, sold, and serviced” in the forum state.  The Bueno defendants argued that Ford Motor did not apply, because that case concerned an injury resulting from actual use of the defendant’s products while, in Bueno, the claims related to a different product – the generic version – manufactured by the defendant’s competitor.  As in Whaley, the court rejected that argument, holding:

. . . Plaintiffs’ warning label claims are about [the branded drug].  Warning label liability is a cause of action against the name-brand manufacturer for the name-brand drug’s warning label that flows by function of law to its generic counterpart.  Defendant asserts that this view ‘conflates California’s recognition of warning label liability with personal jurisdiction.’  The Court disagrees. . . . [U]nder the warning label liability claim, [plaintiffs’ jurisdictional allegations] can be about Defendants’ [branded drug] activities.

Id. at *5.

Obviously, the defendants were exactly right.  Regardless of California’s irrational recognition of innovator liability, the plaintiffs still needed to establish a basis for personal jurisdiction through allegations that the defendants engaged in activities directed at the forum and related to the product that allegedly injured the plaintiffs.  The defendants had no role in the manufacture or sale of the generic drug. If that was the drug that injured the plaintiffs, the defendant’s activities related to the branded drug did not provide a basis for the court to exercise personal jurisdiction over the defendant. 

But the court could not separate the two concepts, so plaintiffs were able to take advantage of their own uncertain product identification pleading in both directions at once. Bueno listed facts establishing that the defendant engaged in ongoing forum-based activities related to the branded drug, then concluded that the court “ha[d] personal jurisdiction over Defendants for the purposes of Plaintiffs’ warning label liability claim even if Plaintiffs only ingested” the generic version.  Which makes absolutely no sense.

Failure to State a Claim

With similar disregard for precedent, the court also denied the defendants’ 12(b)(6) motion addressed to the warnings claims. The defendants cited cases holding that, under California’s learned intermediary doctrine, a plaintiff must identify his prescribing physician, explain how the warnings were inadequate, and explain how an adequate warning would have changed the physician’s prescribing decisions.  Bueno held that it was sufficient that the plaintiffs had pled the second and third elements, and that it “[did] not view the identification of Plaintiffs’ treating physicians as an absolute pleading requirement.”  Id. at *6 (citations omitted). And the survival of the warnings claims facilitated denial of the motion to dismiss the warranty and negligent misrepresentation claims. 

Bueno represents the court’s refusal to acknowledge that it erred in Whaley and its continued misapplication of several legal principles, bolstered by California’s horrific innovator liability jurisprudence.  We will watch for further motion practice in this case, and we will keep you posted.  In the meantime, we will stick to poodles.  Stay safe out there. 

The decision we report on today, Frye v. Novartis Pharms. Corp., 2022 WL 4305656 (E.D. Ark. 2022), leaves us shaking our heads. The court denied the defendant’s motion to dismiss, which was based on preemption and other grounds. In the course of denying the motion, the court misconstrued the law at least once and possibly twice.

Frye involves a biologic designed to treat Neovascular Age-Related Macular Degeneration. Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. See 42 U.S.C. § 262(a). To apply, the manufacturer must submit the label that it proposes using. See 21 C.F.R. § 601.2(a). Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” 21 C.F.R. § 601.2(d).

Once approved, a biologics label generally may not be changed without prior FDA approval. But under certain circumstances, a biologics manufacturer, like a branded-drug manufacturer, may provisionally change a label without prior FDA approval using the Changes Being Effected (CBE) provision found at 21 C.F.R. § 601.12(f)(2). But a label may not be changed under that provision unless the manufacturer possesses “newly acquired information,” which is defined as

data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

21 C.F.R. § 601.12(f)(6).

Plaintiff received the biologic just months after it had been licensed by the FDA. Alleging that the biologic caused her to suffer retinal vascular occlusion, the Frye plaintiff asserted failure-to-warn and other related claims. The biologic’s FDA-sanctioned label described reports of retinal vascular occlusion in patients who received the biologic and identified retinal vascular occlusion as an adverse event observed during clinical trials. Nonetheless, the plaintiff alleged that the label did not adequately warn of the risk.

Relying on allegations that by the time she received the biologic the defendant knew of a reanalysis of the clinical-trial data showing a higher rate of retinal vascular occlusion and was aware of eleven adverse-event reports involving retinal vascular occlusion, the plaintiff argued that the CBE regulation allowed—and state-law required—the defendant to change its label.

The defendant moved to dismiss on, among other grounds, preemption. The defendant argued that the plaintiff’s claims were preempted because, on the facts alleged in the complaint, federal law prohibited it from changing the label as purportedly required by state law. In particular, the defendant argued that the plaintiff alleged no facts plausibly suggesting the existence of “newly acquired information” that would have allowed the defendant to provisionally change the label without prior FDA authorization. Even if the data reanalysis and adverse-event reports were new information in a colloquial sense, the defendant argued, they did not meet the regulatory definition of “newly acquired information” because they did not “reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.” 21 C.F.R. § 601.12(f)(6)

The court denied the defendant’s motion because it was, it said, “unable to conclude that, as a matter of law,” the adverse event reports and data reanalysis did “not constitute newly acquired information of events or analyses revealing risks different in type or of greater severity than previously reported to the FDA.” 2022 WL 4305656, at *8. It’s not clear how best to interpret this rationale. If it is simply a statement about the adequacy of the plaintiff’s complaint, then it is nothing more than a perhaps overly generous application of the federal pleading standards that will have no bearing on summary judgment. But if the court means that the issue of preemption cannot be decided “as a matter of law,” that would be legal error given the Supreme Court’s declaration that the “question of pre-emption is one for a judge to decide, not a jury.” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019).

Whether or not the Frye court properly understands Albrecht, it flatly misconstrued Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Although its analysis is hard to follow, the court seems to find Buckman “inapplicab[le]” because it “concerned a medical device” and Congress enacted “an express preemption provision for medical devices.”  2022 WL 4305656, at *5, *7. From this the court concluded that “impossibility preemption” was the only form of preemption possibly relevant to the plaintiff’s claims. Not so.

Yes, Buckman involved a medical device, and yes, Congress has enacted an express preemption provision applicable to medical devices. But none of that is relevant. Buckman was an implied preemption case, not an express preemption case, that turned on 21 U.S.C. § 337(a), which applies to all products regulated under the FDCA, not 21 U.S.C. § 360k(a), which applies only to medical devices Moreover, although it does not explicitly use the term, Buckman involved obstacle preemption, not impossibility preemption. In other words, it did not depend on the defendant’s inability to simultaneously comply with state and federal law but rather on the fact that applying state law would frustrate Congress’s goal of having the FDA balance competing objectives when deciding how to enforce the FDCA.

Regardless of its underpinnings, Buckman clearly proscribes as preempted state-law fraud-on-the-FDA claims. One would think this holding relevant in Frye given the plaintiff’s allegation that the defendant withheld information regarding the risk of retinal vascular occlusion from the FDA during the licensing process. But the Frye court found otherwise. Although it acknowledged the plaintiff’s allegation that the defendant knowingly failed to present accurate information to the FDA, the court effectively ignored it, saying that, “in context,” the allegation is meant to “illustrate[]” the defendant’s “state of mind” rather than assert “any claim of fraud on the FDA.” 2022 WL 4305656, at *7.

Whether or not denial of the defendant’s motion to dismiss was proper, Frye’s analysis leaves a lot to be desired.

When you depose the other side’s expert, there’s always that string of questions where you collect the admissions of non-expertise.  “You’re not an expert in x?  You’re not an expert in y?  You’re not an expert in z?”  Etc.   Sometimes the expert does some clever fencing.  E.g., “What do you mean by expert?”  Or worse, “I am not sure what you mean by expert, but I have acquired some knowledge over the years via education, training, and experience, so I do know some things about x that might help the finder of fact.” Ugh.  Such an expert has been well trained to use Fed. Rule of Evid. 702 against us.  

But there is a follow-up that usually works pretty well: “You don’t hold yourself out as expert in x, do you?”  Even a skillful witness usually falls for that, and ruefully admits that, no, the witness does not hold him or herself out as an expert in x.  Not our experts, though.  They know to challenge the notion of holding oneself out as an expert.  What does that mean, anyway? Does it mean hanging out a shingle?

Whatever it means, there’s no denying that we hold ourselves as possessing some expertise on the subject of experts.  At least that’s what last week’s DRI program said.  A ballroom full of clients, competitors, and the idly curious sat through 90 minutes of our fellow panelists uttering very wise things, while we mostly ranted.  Our rant was not without some substance. Through education, training, and lots of experience (and lots and lots of mistakes) we have learned a few things about Fed. Rule of Evid. 702 that might be helpful to interested folks, maybe even including you, our readers.

To the extent our rant got especially ranty (raised voice, clenched fists, strained neck muscles), it was on the subject of experts who endeavor to instruct the jury on the law.  That’s almost always a no-no, and rightly so.  There are hybrid areas that are fair game, such as the ways in which industry customs inform contract interpretation.  But in the area of drug and device litigation, most expert efforts to interpret FDA regulations amount to usurpations of the roles of both the judge and jury.

Rebotix Repair, LLC v. Intuitive Surgical, Inc., 2022 U.S. Dist. LEXIS 142875 (M.D. Fla. Aug. 10, 2022), is an interesting example, even if it is an antitrust rather than tort case.  The plaintiff was a company offering a service whereby it “repairs” surgical implements manufactured by the defendant. The court inserted the quotation marks around “repairs,” so something is up with that. Reading between the lines, it appears that the plaintiff’s “repairs” converted the surgical implements from limited use to unlimited use.  The court did not tell us what the alleged antitrust violation was, but it obviously had something to do with the defendant manufacturer trying to shut down or limit the “repair” service.  If the “repair” extended the life of the medical devices, it is not hard to figure out the economic impact at stake. 

The dispute at issue is whether the “repair” service was actually “remanufacturing” of a type that required FDA section 510(k) review and clearance.  After the case was filed, the FDA sent correspondence to the plaintiff insisting that such review was required, but the court did not regard that as a final, dispositive decision.  Thus, the case was not moot and the controversy, at least for now, came down to a battle of the experts.   The issue was what those experts could and could not say.  The plaintiff expert opined that the plaintiff was not a manufacturer or remanufacturer of a medical device and, therefore, no FDA regulatory review was implicated.  The defense expert opined that the plaintiff was remanufacturing a medical device that had been cleared for limited use, and the conversion to unlimited use required FDA clearance.  Each side sought to exclude the opinions of the other side’s expert. The court granted both motions in part and denied them in part.  

The court held that the defense expert could offer opinions that would “help the jury understand the Section 510(k) regulatory framework and provide an explanation of the FDA’s practices and procedures.”  Nevertheless, the expert could not offer an ultimate opinion as to the plaintiff’s “compliance or noncompliance with regulatory requirements.”  That outcome rests on the notion that an expert cannot render a “legal” opinion that certain conduct did or did not violate the law.

Similarly, the court split the baby with respect to the plaintiff expert.  The court brushed aside the objections to the plaintiff expert’s qualifications.  (Yawn.) The court did not brush aside the plaintiff expert’s reliance on a Deutsche Bank report that 510(k) clearance was not required for the plaintiff’s “repair” service.  The report was hearsay resting on unnamed “regulatory consultants,” was not shown to be the type of thing that regulatory experts would rely upon, and was not admissible to demonstrate that the plaintiff expert’s opinion was in accord with a “consensus opinion held by FDA experts.”  Finally, the plaintiff expert could not parade before the jury the ultimate, legal opinion that the plaintiff was not required to obtain FDA regulatory clearance for its “repair” service.  

The Rebotix court’s decision was internally consistent. It forbade both side’s experts from mouthing a “legal” opinion as to whether the “repair” service required FDA regulatory clearance.  The opinion is also consistent with most opinions we have seen addressing regulatory experts.  Courts will not let experts explicitly pronounce conduct as being legal or illegal. But we are uncomfortable with the result in the Rebotix case.  Maybe the permitted opinions about the FDA regulatory framework go just so far and no further.  Maybe they go right up to the line.  But we can’t help but believe that a clever lawyer and clever expert can end up functionally instructing the jury on the law.  Why can’t the judge receive submissions from the parties and then craft a stipulation or jury instruction that sets forth the regulatory framework in a minimal, neutral fashion?

This post is from the non-Reed Smith side of the blog.

We could have titled today’s post something like Back to Basics or Legal Writing 101 because that is how the opinion in McGuire v. Abbott Laboratories, Inc., 2022 WL 4295402 (E.D. Tex. Sep. 15, 2022) reads.  In other words, it provides a lot of detail on the legal framework and then reaches a conclusion with very little fanfare.  The opinion is simple and straightforward and so we will attempt to be too.

The product at issue was an implantable cardioverter defibrillator (“ICD”), which is a Class III, Pre-Market approval medical device.  Defendant moved to dismiss all claims as preempted and for failure to satisfy the TwIqbal pleading standards.  Id. at *1. 

The decision starts with a notably lengthy discussion of the pleading standards.  The court devotes several paragraphs to conclusory allegations.  Explaining, for example, that in deciding a motion to dismiss, while the court must accept plaintiff’s factual allegations as true—the court should not “strain” to “accept conclusory allegations, unwarranted deductions, or legal conclusions.”  Id. In fact, conclusory allegations should not be accepted as true by the court.  Id. at *2 (citation omitted).  The court cannot guess at the factual support.  It is up to plaintiff to provide sufficient details to make the requested relief “plausible, not merely conceivable, when taken as true.”  Id. 

Next, the court explains why it can take judicial notice of two PMA approval letters from the FDA.  Because the letters are publicly available and relevant to an issue to be decided—whether the product is governed by FDA regulations.   And, because defendants asked.  Id. at *3.

The court next discussed federal preemption both generally and as it pertains to PMA medical devices.  Specifically, the two-prong test of Riegel.  The ICD automatically satisfies prong one—it is subject to federal regulations—because it underwent the FDA’s PMA process.  Id. at *4.  Prong two is whether plaintiff’s claims are in conflict with those federal regulations or run parallel to them.  If the former, they are preempted.  Id. at *5.  Which brings us to the court’s conclusion – the intersection between TwIqbal and Riegel:

[Plaintiff] asserts product liability and negligence causes of action against [the manufacturer] related to the manufacture, design, and marketing of the [PMA medical device]. [Plaintiff]’s petition, however, does not plead a violation of any federal requirement relating to the manufacture, design, or marketing of the [device]. Moreover, there are no facts set forth in the petition supporting a finding of any such violation. [Plaintiff] fails to point out any specific defect in the manufacturing process or design, any deviation from the FDA-approved design or manufacturing process, or any causal connection between a violation of federal requirements and his injuries. . . . Thus, [plaintiff]’s claims are too conclusory to be deemed parallel claims that are not subject to preemption under § 360k(a).

Id. at *5

Summed up nice and neat—plaintiff’s complaint simply was not enough to “nudge the claims across the line from conceivable to plausible.”  Id. at *2 (citation omitted).

And, plaintiff could not fix their conclusory pleadings by relying on res ipsa loquitur.  Simply because the device malfunctioned “does not establish [defendant’s] negligence.”  Id. at *5.  A device can fail without violating an FDA safety standard.  Id.  Plaintiff is getting a second bite at the apple, but they are going to need more than res ipsa loquitur to avoid the same outcome a second time.

Bexis recently returned from speaking at the 2022 National Vaccine Law Conference.  As a veteran of both the DTP and thimerosal vaccine litigations, he was generally interested in vaccine-related product liability issues, so he stayed for the entire conference.  He was most interested in learning more about the compensation systems provided by the National Childhood Vaccine Injury Act and the PREP Act.  The Vaccine Act, 42 U.S.C. §300aa-10 et seq., seemed most relevant, since the layers of preemption imposed by the PREP Act make product liability litigation over use of PREP Act “covered countermeasures” (which include vaccines) extremely unlikely.

Continue Reading Thoughts on a Vaccine Act MDL

Longtime readers of the Blog know we have a soft spot in our hearts for Nebraska.  The state motto—“Equality Before the Law”—is both elegant and meaningful, and we should also call it progressive, given that it dates back to 1867—one year before ratification of the Fourteenth Amendment.  We have also previously shared our affection for the shallow, meandering Platte River, which is among North America’s most underrated waterways.  Not because of its navigability—as Bexis says, the Platte River is “a mile wide and six inches deep”—but because the Platte River Valley has been an overland highway to the West for hundreds of years.  That now includes the option of Interstate 80, which traverses the river multiple times as it makes its way up a gentle slope to the Rocky Mountains. 

Well, what if you get sued in Nebraska?  That is what happened to a New Jersey-based pharmaceutical company in Bishop v. Amneal Pharm. Pvt. Ltd., No. 8:22-cv-11, 2022 WL 4000544 (D. Neb. Sept. 1, 2022), and a federal judge in the District of Nebraska filed a very useful order dismissing that out-of-state defendant for a lack of personal jurisdiction. 

It seems that personal jurisdiction based on a “stream of commerce” runs no deeper than the Platte.  And for good reason.  The Nebraska plaintiff alleged “on information and belief” that the New Jersey defendant was the distributor of the prescription drug she took while residing in Nebraska, which would be the kind of forum contact that could support specific personal jurisdiction.  What was the “information” upon which she formed that “belief”?  Not much, if anything.  She was prescribed the drug in Nebraska; she ingested the drug in Nebraska; and she purchased the drug from a Nebraska pharmacy that printed part of the defendant’s name in its records.  Id. at *4.  That is all fine and good, but there is nothing there about who actually distributed the product in Nebraska. 

By comparison, the defendant submitted a declaration stating that it did not engage in any business in Nebraska and distributed its products only through third-party distributors.  Id. at *3-*4.  Based on these facts, the district court dismissed the defendant from the case.  The plaintiff bears the burden of establishing a prima facie case of personal jurisdiction, and while the court will view the facts in the light most favorable to the plaintiff, “conclusory allegations and speculation are insufficient where no other allegations provide plausible factual support.”  Id. at *7. 

The plaintiff fell short of her burden.  Her allegation that the defendant distributed the drugs that she ingested were “on information and belief,” which are “only conclusory and speculative.”  Id. at *9.  A pharmacy record included the defendant’s name, but that exhibit alone allowed no plausible inference that this particular defendant actually distributed the product in Nebraska.  Id.  Nor was it sufficient that the defendant placed the product into the stream of commerce knowing that it would be sold in Nebraska.  The district court knew that because of the U.S. Supreme Court’s opinion in Bristol-Myers Squibb:

In Bristol-Myers Squibb, the Court linked specific jurisdiction either to a foreign defendant’s particular acts within the forum or the particular acts of its agent and/or alter ego subsidiary/distributor.  137 U.S. at 1781-83.  Specifically, the Court stated, “[T]he bare fact that [a foreign defendant] contracts with [a forum-state] distributor is not enough to establish personal jurisdiction.”

Id. (quoting Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), emphasis ours).  The defendant’s declaration established without contradiction that it distributed its products in Nebraska only through third-party distributors.  Thus, to the extent the plaintiff was basing personal jurisdiction on the mere foreseeability flowing from the defendant’s relationships with third parties, that theory was “inapplicable in light of Bristol-Myers.”  Id.  As we discussed shortly after Bristol-Myers Squibb was decided, constraining the scope of the questionable stream-of-commerce jurisdictional theory was one of the key points of that case.  Due process does not permit taking personal jurisdiction over one entity based only on the forum contacts of another.  More is required.

The major takeaways from Bishop are that (1) pleading “on information and belief” will not carry the day when seeking to establish personal jurisdiction and (2) merely placing a product into the stream of commerce will not suffice either, even when it is foreseeable that the product will reach the forum. 

There are, however, two additional points worth noting.  First, both sides challenged the court’s jurisdiction:  The defendant challenged personal jurisdiction, and the plaintiff challenged subject matter jurisdiction following the defendant’s removal of the case to federal court.  The district court decided personal jurisdiction first, which was a good outcome for the defendant because it resulted in dismissal, as opposed to a remand to state court.  Id. at *5-*6.  Federal courts usually handle dueling jurisdiction challenges like these in this sequence (see for example here, here, and here), but not always. 

Second, the district court denied the plaintiff’s request to take jurisdictional discovery.  The plaintiff’s assertion that discovery might reveal the nature of the defendant’s contracts and communications with downstream distributors was “entirely speculative and conclusory.”  In other words, the plaintiff was seeking “an unwarranted fishing expedition” into jurisdictional facts that were not reasonably controvertible.  Id. at *10.  Enough said.  We are told the fishing for rainbow and brown trout in the Platte River is pretty good. 

When we say “bananas,” today’s case is actually about bananas, that herb people tend to call a fruit.  It is also quite unusual and complicated.  Because it also involves some tragic underlying events, our quips are done.  A bit of etymology is warranted, though.  We used the term “judge-made law” in the title and that can have a negative connotation sometimes.  Many of the substantive due process rights recognized by the United States Supreme Court in the roughly seventy years before the current term could be called “judge-made.”  Critics of those decisions might even label the justices who authored them as “activist judges,” which we find to be an over-used appellation.  When referring to common law, which still forms a large chunk of the law we feature on this Blog, there is typically no dig about its origin.  Was Judge Pigot an activist judge when he wrote the decision in the “Case of Thorns” (Hulle v. Orynge)?  Are the early state cases recognizing the learned intermediary doctrine for cases about prescription medical products more “judge-made” than those that followed that carved out exceptions?  We suppose this is one of those “eye of the beholder,” or perhaps “mouth of the advocate,” situations.

In Garcia v. Chiquita Brands Int’l, Inc., __ F.4th __, 2022 WL 4100393 (11th Cir. Sept. 8, 2022), the application by a federal court sitting in diversity of the Colombian statute of limitations for personal injury actions turns in large part on the class action tolling rule being “judge-made law.”  We will try to unpack this mad tangle of Erie R.R. Co. v. Tomkins, choice of law, and class action law.  Usually when we talk about Erie here, we are talking about the need for federal courts sitting in diversity to exercise restraint when they predict state law.  For instance, in a case about a class III medical device, the court should be very hesitant to create some new state cause of action as a way to create a path to avoid preemption.  The judges on a state’s highest court can make new law, but the federal judge sitting in diversity really should not.  Garcia adds the wrinkle of what happens when the “state” is another country.  The short answer is that there should be similar restraint, but the steps to get there are not simple.

Our recounting of the underlying facts and procedural posture, however, has been simplified.  The defendant apparently utilized the services of AUC, a well-known paramilitary/terrorist group—see Narcos and other depictions of the cocaine trade—to intimidate banana workers through acts of violence.  We say “apparently” instead of “allegedly” because the defendant pleaded guilty to violating a presidential order relating to national security under 50 U.S.C. § 1705(b).  2022 WL 4100393, *2.  (We note that Garcia says this plea happened in the “District Court for the District of Colombia [sic]” and that 1705(b) is the civil penalties subsection, but we will treat it like Garcia did—as a violation of U.S. criminal law.)  In 2007, those allegedly affected by these acts brought a class action called Cardona in the District of New Jersey under the Alien Tort Statute, the Torture Victims Protection Act, New Jersey law, and Colombian law.  Cardona was sent with other actions to a new MDL down in the Southern District of Florida in 2008.  Eventually, after some claims had been culled, in March 2017, the Cardona plaintiffs sought to amend to add “several hundred additional plaintiffs.”  That was denied and, in May 2019, so was class certification.  Then those additional plaintiffs—presumably all Colombian citizens—brought a new (non-class) suit in the District of New Jersey—the defendant is incorporated in NJ—asserting a range of claims under New Jersey and Colombia (but not federal) law.  The new case was sent back to the same aged MDL in the Southern District of Florida.  Then, the Colombian claims were dismissed with prejudice as time-barred and the New Jersey claims were dismissed on extraterritoriality.  After the denial of a Rule 59 motion, an appeal followed on the Colombian claims only.

As different as the facts and case history above are from what we normally cover, there are several common issues.  Most of them are more on the procedural side, but class action tolling popularized in the U.S. Supreme Court’s American Pipe decision can have a major impact in serial product liability litigation.  We can remember many exchanges where we describe our core practice to a non-lawyer and have been met with a version of “oh, you do class actions.”  Our response, time and patience permitting, may explain why class actions tend not to work for these sorts of cases except for settlement classes.  Our elevator explanation notwithstanding, persistent plaintiff lawyers do bring class actions that have broad proposed class definitions that would make many future plaintiffs “putative class members.”  Because the nature of modern advertising-driven litigation means that a chunk of all claims will be brought after the statutes of limitation have expired absent some sort of tolling, the pendency of a class action—and they do tend to pend—can save a bunch of cases that would otherwise be S.O.L. on S.O.L.  This is particular problematic where the class action was pending in a different jurisdiction than where the otherwise time-barred cases were brought.  Indeed, if Garcia had involved two states, rather than a state and a sovereign nation, then we would have included it on our cross-jurisdictional class action tolling scorecard.

Colombia has a ten-year statute of limitations for the individual claims asserted in Garcia and the conduct at issue all occurred before 2005.  Garcia was filed in March 2020, so even if the 2017 request to amend in Cardona counted as initiation of the claims in Garcia, significant tolling would be required to save every claim from the Colombia statute of limitations, if it applied.  Twelve years of class action tolling, if it applied, would do the trick.  But how do you get American Pipe to apply to claims brought under Colombia law in a case filed directly in the District of New Jersey?  Here, at least, the answer was that you cannot mix and match like that.

Based on Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3 (1975), the analysis for determining whether to apply the substantive law of a foreign country is the same as for substantive state law.  2022 WL 4100393, **3-4.  The Eleventh Circuit developed a “four-step process” for deciding which law should apply under Erie.  Id. at *4 (citing Esfeld v. Costa Crociere, 289 F.3d 1300 (11th Cir. 2002)).  Garcia was filed in a federal court New Jersey, so its choice-of-law rules apply despite the transfer.  Being a state with lots of out-of-state plaintiffs in its courts, New Jersey had specific guidance on determining choice-of-law for statute of limitations.  Id. at *5 (citing one of the many McCarrell decisions from Accutane litigation).  Choice of law analyses always start with determining a conflict.  New Jersey has class action tolling and, according to Garcia, Colombia does not.  The latter determination involved a deep dive into Colombia’s law, which we will skip.  The tenor, though, was one of restraint, rather than projecting the court’s view of what the law should be:

In short, Colombian law has not spoken on class tolling.  And that silence speaks volumes because, as a civil law country, Colombia establishes its laws almost exclusively through criminal and civil statutes – not from the decisions of its courts.

Id. at *6.  Because the application of class action tolling vel non would be outcome determinative, the next steps under McCarrell were to determine if maintaining an action “would serve no substantial interest” of New Jersey and if Colombia had a “more significant relationship to the parties and the occurrence.”  Id. at *8.  Both clearly weighed in favor of applying Colombia’s statute of limitation law, which would bar the claims.

The next inquiry under Erie/Esfeld was “whether a congressional statute or Federal Rule of Civil Procedure covers the disputed issue.”  Id. at *9 (citation omitted).  The inquiry was not whether “federal law covers the disputed issue.”  Class action tolling under American Pipe may be federal law, but it came from judges and has not been incorporated into the Federal Rules of Civil Procedure.  In this sense, the law established by a clear Supreme Court decision did not count.  Id.  If it did, then the result of the New Jersey choice-of-law analysis would have been reversed.  We can dispense with the last two Erie/Esfeld inquiries fairly quickly.  Failure to apply Colombia’s law would lead to different outcomes in state and federal court, which is contrary to one of the purposes of Erie.  Id.  In addition, federal interests did not weigh in favor of applying federal law over Colombia’s laws.  Id. at **10-12.  While Garcia did not expressly address the issue of whether cross-jurisdictional class action tolling is ever appropriate, we note that it did cite a few cases that did reject this particular species of tolling.  Compare id. at *12 with this post.  It did recognize that New Jersey’s interest in having its class action tolling apply was limited because the prior Cardona class on which potential tolling would be based was filed in New Jersey state court.  2022 WL 4100393, *9.  In the end, of course, an attempt at cross-jurisdictional class action tolling was rejected.

All of that analysis came across as thorough and well-reasoned.  While we certainly have no dog in the fight, Garcia’s decision to reverse of dismissal with prejudice and remand with instructions that plaintiffs should be permitted to amend did not.  For one thing, it was analyzed under Fed. R. Civ. P. 15, which is the right rule for addressing a motion to amend a pleading.  But plaintiffs filed a motion to alter or amend the judgment under Fed. R. Civ. P. 59(e).  Although Garcia referred to this loosely as an “application to amend” and a “request to amend,” it is not the same thing as a motion to amend a pleading.  Id. at *3.  Second, given the long history here, relying on a pre-TwIqbal case that a plaintiff should get a second shot to state a claim with a “more carefully drafted complaint” is not terribly persuasive.  Id. at *13 (citation omitted).  Third, the rejection of the district court’s ruling that plaintiffs had waived an alternative tolling argument—that some of them were minors before March 2010—because “dismissal with prejudice” was a “hefty sanction” seemed off.  Id. at *14.  Dismissal here was based on the determination, after full briefing, that the case was time-barred, not as a sanction.  We are used to the old saw that appellate courts like to find waiver.  Maybe that is just judge-made, so it did not count here.

It has been just about two years since the Central District of California dismissed the claims in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc. as impermissible attempts to privately enforce the FDCA and therefore impliedly preempted.  We blogged about that decision back then.  At that time, we noted that while the case arose in the context of a business dispute, the preemption principles it enforced are equally applicable to product liability and other tort claims (including unfair competition claims) that are brought against our clients.  For that reason, we promised to keep bringing these types of decisions to our readers’ attention.  Much to our delight, we now have a federal appellate decision upholding the dismissal. 

The drug at issue, ephedrine sulfate, is administered to surgical patients if their blood pressure drops too low.  The drug is typically sold at a concentration that needs to be diluted before it can be administered to patients.  Plaintiff developed a ready-to-use version which has been FDA-approved.  Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., — F.4th –, 2022 WL 4175106, *1 (9th Cir. Sept. 13, 2022).  Defendant, a network of compounding pharmacies, sells ephedrine sulfate in ready-to-use syringes.  As a compounder, defendant does not need to seek FDA-approval for its product.  But drug compounders are still subject to other FDA requirements, particularly large-scale compounders.  Large-scale compounders have to register with the FDA, provide yearly reporting, and are subject to inspection.  Id. at *2.  The concern is making sure compounders do not become generic drug manufacturers by “wholesale copying” FDA-approved drugs without any of the safeguards that govern generic drug manufacturing.  Therefore, compounders are exempt from needing FDA-approval for their drugs unless the compounded drugs are “essentially a copy of one or more approved drugs.”  Id. 

Plaintiff’s theory of the case is that the laws of California, Florida, Connecticut, Pennsylvania, and Arizona prohibit the sale of drugs not approved by the FDA.  And, defendant’s product is neither FDA-approved nor subject to the exception to the FDA-approval requirement because it is essentially a copy of plaintiff’s drug.  Therefore, defendant is in violation of those states’ laws and plaintiff is entitled to economic damages.  Id. at *3.  However, the FDA itself has not found defendant violated the FDCA. So, asking a court to find a violation is a form of prohibited private FDCA enforcement.  In other words, if the FDA has not concluded that the defendant’s drugs were “essentially a copy,” plaintiff cannot ask a court to do so. 

This was the Ninth Circuit’s first time to interpret this provision of the FDCA—whether a compounded drug is a “essentially a copy” of an FDA-approved drug.  So, its analysis is like a walk down implied preemption memory lane.  While the first stop is Medtronic v. Lohr, the court lingered there only a moment finding Buckman to be the more analogous way point.  The fraud claims in Buckman existed “solely by virtue of the FDCA” rather than sounding in “traditional state tort law.”  Id. at *4.  Like the claims in the current case which seek to hold defendant liable for violating a state law that itself relies on the federal statute, not traditional state tort law.  Id.  The court completed the medical device leg of the journey with Riegel, which because it is based on express preemption was also not analogous to the current case.  What the court did find important about Lohr, Buckman, and Reigel to the question at hand was that the claims that were not preempted, “were made by patients injured by defective medical devices, who pleaded traditional common law tort claims.”  Not present in this case. Moving farther along to prescription drug preemption cases, the court started with Wyeth v. Levine.  Again finding it distinguishable because it was based on traditional state tort law whereas “a necessary element of [plaintiff’s] claim is the alleged violation of the FDCA.  Id. at *6.  The court’s next stop was at one of its own cases which is quite on point.  In Photomedex v. Irwin, a medical device manufacturer sued a competitor alleging certain statements in its marketing materials violated the FDCA.  Plaintiff manufacturer argued that the prohibition on private enforcement of the FDCA did not apply because it was suing under the Lanham Act and state unfair competition laws.  Relying on that decision here, the court said:

to the extent the claim was based on a arguably false assertion of FDA approval, it “would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that there was a violation,” so the action was barred by the FDCA’s prohibition of private enforcement.  That claim could only be permissibly made by the government. . . Like PhotoMedex, Nexus’s claims would require litigation of whether Central Admixture’s compounded drugs are “essentially a copy” of Emerphed where the FDA has not itself so concluded.

Id. (quoting 601 F.3d 919 (9th Cir. 2022).

Sticking with Ninth Circuit cases, the preemption path takes a bit of a sharp turn to arrive at Stengel which the court distinguished as involving a traditional state tort law duty and as not addressing the ban on private enforcement of the FDCA.  With Stengel put to the side, Ninth Circuit law is pretty clear:

to permit [plaintiff] “to proceed with a claim that Defendants violated this law when the FDA did not so determine would, in effect, permit [plaintiff] to assume enforcement power which the statute does not allow and require the finder of fact to make a decision that the FDA itself did not make.” Proceedings to enforce or restrain violations of the FDCA, including the compounding statute, must be by and in the name of the United States, not a private party. Nexus’s claim is such a proceeding, so it is barred by the exclusive enforcement statute.

Id. at *7.

Finally, the Ninth Circuit took this opportunity to state that Allergan v. Athena, 783 F.3d 1350 (Fed. Cir. 2013) was wrongly decided.  In that case, the manufacturer of an FDA-approved product sued the manufacturer of a non-FDA-approved product for violation of California’s unfair competition law.  The Federal Circuit reasoned that because California’s law “merely incorporated FDCA requirements,” the laws were not in conflict and therefore, the claims were not impliedly preempted.  However, the Federal Circuit did not address the prohibition on private enforcement.  Had it done so, Photomedex, would have required a different result because a claim for economic harm by reason of an alleged FDCA violation is not a traditional common-law tort that may have an avenue to escape preemption.  Id. at *7-8.  On the issue of being “essentially a copy,” the FDA has issued a guidance and has indicated it plans to issue clarifying regulations.  These are not agency decisions, but they show the FDA is grappling with the issue.  And the important question of whether defendant’s drug is “essentially a copy” of plaintiff’s drug, is a question that must be left to the FDA’s discretion to decide how and when to enforce the statute.

We are particularly interested in the Ninth Circuit’s ruling applying Buckman preemption because “in the case before us, [plaintiff] relies on a state statute which itself relies on the federal statute, not traditional state tort law theory.” Id. at *4. That holding goes way beyond pharmacy compounding and potentially strikes at the heart of the California courts’ permission of (primarily) food cases that are really attempts to enforce the FDCA. As we described in our 2008 post about Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008), that decision cobbled together two state statutes of the sort now addressed in Nexus Pharmaceuticals to create a path to liability:

What [Farm Raised Salmon] wound up with, with respect to food violation claims, is . . . : (1) the FDCA allows state “little FDCA statutes” that incorporate identical food rules, but doesn’t otherwise authorize state-law (much less, private) enforcement; (2) California enacted a little FDCA statute, the Sherman Act, but that didn’t allow private enforcement either, (3) later, California enacted consumer protection statutes that did allow private enforcement, but did not specifically address food, so (4) California courts decided to incorporate globally into the consumer protection statutes any number of other statutes (such as the Sherman Act on food) that did not themselves contemplate private enforcement.

The Ninth Circuit has now held that the linchpin of the California-law basis for incorporating FDA standards in food litigation is not a “traditional state tort law theory” that can escape Buckman preemption. It is not a parallel claim, rather it is “a state statute which itself relies on the federal statute.” We expect Nexus Pharmaceuticals to be the basis of many preemption motions going forward, which is why we were so interested in this litigation to begin with.

Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. § 314.70(c)(6)(iii)(A). Because the FDCA requires generic versions of a drug to carry the same label as the branded version and thus prohibits generic manufacturers from unilaterally changing their labels even provisionally, failure-to-warn claims implicating generic drugs are preempted (so long as the generic manufacturer provided the drug’s FDA-approved warning label). Branded manufacturers, by contrast, may unilaterally change their labels under certain circumstances. To do so, the manufacturer must have “newly acquired information,” which is defined as “data, analyses, or other information not previously submitted to the [FDA], which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.” 21 C.F.R. § 314.3(b). Because federal law prohibits a pharmaceutical manufacturer from unilaterally changing its label absent “newly acquired information,” in the absence of such information it is impossible for a manufacturer to simultaneously comply with federal law and a putative state-law duty to change its label.

The issue in today’s case, R.S.B. ex rel. Hammar v. Merck & Co., 2022 WL 3927868 (E.D. Wis. 2022), was whether there was “newly acquired information” that would have allowed the branded drug manufacturer to use the CBE regulation to change its label to comply with a purported state-law duty to warn of a particular risk supposedly associated with its product. Concluding that there was no such information, and that federal law therefore prohibited a labeling change, the court held that the plaintiff’s failure-to-warn claim was preempted.

The plaintiffs argued that there were two pieces of newly acquired information that would have allowed the manufacturer to change its label—an expert’s reanalysis of previously known data and an academic article reporting on an adverse event associated with the drug. The Hammar court found neither constituted “newly acquired information” for purposes of 21 C.F.R. § 314.70.

According to the plaintiffs, their expert’s reanalysis of previously published data showed that the drug in question had a higher risk of neuropsychiatric side effects than originally reported to the FDA. The Hammar court rejected the reanalysis on two grounds. First, the court said that it could not rely on the expert’s purported opinion because the plaintiffs had failed to place her report in the record. Second, and more importantly, the court held that even if it did consider the expert’s reanalysis the reanalysis did “not constitute newly acquired information” because it was “litigation-driven and unsupported by any published research.” 2022 WL 3927868, at *4 (citing In re Incretin-Based Therapies Prods. Liab. Litig., 524 F. Supp. 3d 1007, 1024–25 (S.D. Cal. 2021), aff’d, 2022 WL 898595 (9th Cir. 2022)). As the court put it, “Plaintiffs are not entitled to create their own ‘newly acquired information’ through the use of experts.” Id. (quoting R.S.B. v. Merck & Co., Inc., 2021 WL 6128161, at *4 (E.D. Wis. 2021)).

Tacitly acknowledging that the manufacturer did not know of the reanalysis when its drug was ingested, the plaintiffs argued that the manufacturer “could have undertaken the same analysis” as the plaintiffs’ expert had and that, “had it done so, it would have had information that allowed it to invoke the CBE regulation.” 2022 WL 3927868, at *4. The court, however, rejected the plaintiffs’ “attempt to shift the burden” of locating new information onto the manufacturer, holding that the plaintiffs’ “burden-shifting argument upends the preemption framework laid out by the various Courts of Appeal and would allow litigants to circumvent it by merely alleging that a manufacturer should have created the newly acquired information.” Id. (internal quotation marks omitted). “Such an argument, said the court, “cannot stand.” Id. Indeed, the regulation’s text precludes such an argument inasmuch as it predicates use of the CBE regulation on information that is newly acquired, not on information that could be newly acquired.

The court also found no merit to the plaintiffs’ contention that the adverse event reported in the medical literature constituted “newly acquired information” that would have allowed use of the CBE provision. According to the court, “[a] single report, unaccompanied by any significant analysis, does not demonstrate the existence of a risk that is of a different type or greater severity or frequency, such that a manufacturer can invoke the CBE regulation. 2022 WL 3927868, at *4. To the contrary, “[c]ourts have … rejected the notion that analyses based on adverse event reports—much less the reports standing alone—can constitute ‘newly acquired information.’” Id. (quoting Gayle v. Pfizer Inc., 452 F. Supp. 3d 78, 88 (S.D.N.Y. 2020), aff’d, 847 F. App’x 79 (2d Cir. 2021)).

So, two take-aways for practitioners litigating failure-to-warn claims implicating a branded drug:  First, the mere fact that the manufacturer could have uncovered certain information does not mean that the manufacturer actually possessed “newly acquired information.” Second, anecdotal adverse-event reports do not constitute “newly acquired information” within the meaning of the CBE regulation.

Go forth and defend.

Quick puppy update:  the standard poodle puppies, one of which will be our first-ever show dog in a house filled with canine and feline rescued ragamuffins, are four weeks old today.  All eight are fat and healthy, despite a scare with one white male puppy a week or so ago.  We will meet them this weekend and will soon know which will be ours.  We remain deliriously excited and stubbornly in denial about the havoc this will wreak on our well-ordered life. 

We bolster ourselves with well-ordered legal decisions, like today’s defense summary judgment victory.  In Eiter v. Wright Medical Technology, Inc., 2022 WL 4104559 (D. Ariz., Sept. 8, 2022), the plaintiff alleged that she was injured by the defendant’s artificial hip.  Her complaint included the usual litany of product liability claims, and the defendant moved for summary judgment on the failure-to-warn claims sounding in both negligence and strict liability and on the claim for punitive damages. 

Failure-to-Warn Claims

To prevail on failure-to-warn claim under Arizona law, as the court explained, a plaintiff must prove that an inadequate warning proximately caused her injuries (so-called “warnings causation”).  Eiter is a prescription medical device case, subject to the learned intermediary doctrine, so the plaintiff was required to adduce evidence that a different or stronger warning would have changed her surgeon’s decision to implant her with the artificial hip.  One wrinkle:  Arizona has adopted a heeding presumption that applies to strict liability failure-to-warn claims; in other words, “a plaintiff is entitled to a presumption that the injury would have been avoided with an adequate warning.”  Eiter, 2022 WL 4104559 at *2.  But the presumption is rebuttable:  if the defendant adduces evidence that the learned intermediary would not have heeded an adequate warning, the burden shifts back to the plaintiff to prove “warnings causation.” 

Eiter was a failure-to-read case.  The defendant argued that the plaintiff could not prove that an adequate warning would have altered her doctor’s prescribing decision because the doctor had not read the Instructions for Use (“IFU”) that accompanied the product, and because the doctor was already aware of the relevant risk (injury from metal debris).   The defendant cited the doctor’s deposition, in which he testified that he did not recall reading the IFU, and that he was aware of the risk of injury “from increased production of wear particles” causing damage to the bone, and the court held that this testimony was sufficient to rebut the heeding presumption. 

The plaintiff argued that, while the doctor did not remember reading the IFU, he had “since reviewed it and found it lacking,” id. at *3, but the court held that this did not create a genuine issue of material fact.   Moreover, the court held, the plaintiff “produce[d] no evidence to show that [the doctor] was not already aware of the risks that [were] alleged to cause [the plaintiff’s] injury.”  In his deposition, the doctor testified that he was “of course aware of the risks posed by metal debris.”  After the fact, the doctor signed an affidavit in which he stated that he was not aware of failures of the plaintiff’s specific device from tissue reactions to metal debris.   The court held, 

Although [the doctor] may not have been aware of the particular failures with Defendant’s product, . . . .he was aware generally of the risks that such products presented.  As such, there is no evidence showing that a specific warning about the risks that [the doctor] already recognized would have changed his decision” to implant the defendant’s artificial hip. 

Id.

(In an interesting aside, the court considered the defendant’s argument that the affidavit should not be considered at all because it was a “sham affidavit”  Under the “sham affidavit doctrine” (one of our favorites), a party opposing summary judgment cannot create fact issues by crafting an affidavit that contradicts the affiant’s sworn deposition testimony.  In this case, the court held that the affidavit did not contradict the doctor’s deposition testimony, so it was not a “sham” and would not be disregarded.)

Bottom line:  because there was no evidence that the doctor had read the IFU, and because he already knew of the relevant risk, the plaintiff failed to create a fact issue on the causation element of the failure-to-warn claims.  

Punitive Damages

To prevail on a claim for punitive damages under Arizona law, a plaintiff must prove that the defendant “consciously and deliberately acted with an evil mind.”  Id.  (internal punctuation and citations omitted). The plaintiff argued that the defendant’s decision to continue selling the artificial hip, even though it was aware of the risks associated with the device, satisfied the “evil mind” standard.  The court disagreed, holding that “such knowledge only deserves punitive damages when the risks would incur inevitable or highly probable harm,”and the plaintiff had not cited evidence that “the harm was highly probable or inevitable.”  Id. (You can read more about punitive damages standards here.)

Eiter is a tidy little decision, no less satisfying because the correct result was obvious.  We’ll talk to you soon.  In the meantime, stay safe out there.