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In our first appellate oral argument we found ourselves in front of a very hot Ninth Circuit panel (that means lots of questions).  We danced our hardest to affirm the district court’s denial of a criminal defendant’s motion to suppress. The problem was that the lower court had wandered onto shaky ground.  We knew it.  We had tried to avoid it.  We knew our best chance for affirmance was persuading the Ninth Circuit to affirm on alternative grounds (the ones we had urged below). Thankfully, they did it.  For some reason, winning on alternative grounds made us feel extra proud.  At least the appellate section nerds in the U.S. Attorney’s office would continue to let us handle our own appeals. 

In Azurity Pharmaceuticals, Inc. v. Edge Pharma, LLC, 2022 WL 3335823 (1st Cir. Aug. 12, 2022), the appellee managed to save most of the lower court’s decision in its favor by resorting to alternative grounds.   That must have made the appellee’s lawyers feel pretty good.  But note that we said “most.”  There was a partial reversal, and that must have made the appellee lawyers feel pretty bad.  And we feel pretty bad about that, because we like the lower court decision to the extent it chose to defer to the Food and Drug Administration (FDA). If that sort of deference was more prevalent, we could get rid of a lot of silly food and drug litigation from our courts, leaving those courts to handle the things that really matter — you know, like criminal cases and celebrity defamation lawsuits.  

The Azurity case was a beef between a specialty pharmaceutical company that sold an FDA premarket approval drug and a drug compounding company that sold a competing drug that had not been given FDA premarket approval.  Section 503B of the Food, Drug and Cosmetic Act permits drug compounders to market their compounded drugs without FDA approval as long as they meet certain conditions.  On its website, the compounder stated that it complied with FDA regulations, that it was a registered and inspected FDA outsourcing facility, and that “commercially available options are not ideal for use in the hospital setting.”  That last point was a shot at the premarket approval drug.  The manufacturer of that premarket approval drug alleged that the statement was an inaccurate superiority claim, and that, in fact, much of what was on the compounder’s website was either flat-out false or misleading.  These allegations resided in a complaint that included causes of action under both the Lanham Act and a Massachusetts consumer protection law.

The district court granted the compounder’s motion to dismiss, holding that the claims would require the court to interpret section 503B “in a way that would interfere with the FDA’s authority to administer and enforce the FDCA.”  The court referred to “FDA preclusion,” which is not the same thing as FDA preemption (an argument that was not raised by the plaintiff).  The district court also premised its dismissal on primary jurisdiction.  In short, let the FDA sort these issues out, because they seem too gnarly for the court.  

The First Circuit disagreed with the district court’s fundamental rationale that the issues in the case called for FDA expertise.  To the appellate court, the FDA issues were fairly straightforward (but go ahead and read the First Circuit’s lengthy opinion and see if you agree — we’ve read epidemiology and epistemology and eschatological (but not scatological) articles that were less dense and dull), and handling the Lanham Act analysis was a walk in the park.  For the most part, that Lanham Act analysis still worked in the defendant compounder’s favor.  The plaintiff argued that the compounder was not in compliance with FDA rules because its compounded drug was essentially a copy of the premarket approval drug — which would yank the compounder out of section 503B eligibility — but the First Circuit held that the plaintiff had not plausibly shown that the compounder “made any literally false description or representation of fact.”  The plaintiff relied on an FDA non-binding guidance to explain what it meant for a compound to be “essentially a copy” of another drug, but there was some looseness in the non-binding guidance, plus it was … non-binding.  Similarly, the First Circuit concluded that the compounder’s statement that other drugs were “not ideal” was not a superiority claim.  What it was, dear reader, was “nonactionable puffery.”

We will pause for a moment to allow you to rinse out of your mind bad memories of your law school first year contracts class.  Remember how ridiculous advertising escaped the clutches of the law by riding the greasy wheels of “puffery”?  For that matter, do you remember the room said to offer a view of the King’s coronation?  What about that pregnant cow? And what exactly is a chicken? 

But we digress.

Anyway, up to this point, the First Circuit upheld the dismissal of the complaint (both the Lanham Act and Massachusetts consumer act claims, since they traveled together and tested on the same theories) but on different grounds from those relied upon by the district court.   But here is where the First Circuit parted company with the district court, revived the lawsuit, sent things back, and brought woe upon the compounder:  the plaintiff alleged that the bulk substance used by the compounder was not on the section 503B bulk substance list (which appears to focus on clinical needs and/or shortages).  The compounder had some decent arguments why that issue should be punted to the FDA, based on FDA practice and policy, but the First Circuit said that nothing sufficiently on point supporting that notion had been identified, that the court was in a solid enough position to look at the issue, and what the court saw was (and now, given that it is now March, we will shift the sports analogy from football to basketball) a jump ball.  Maybe the plaintiff was right, maybe the plaintiff was wrong, but there was inadequate basis, at least at the point of a motion to dismiss, to throw the plaintiff out of court.

As we said, we rather liked the defendant’s and the district court’s reliance on deference to the FDA.  The First Circuit’s opinion was certainly thoughtful and thorough.  It might even be right. But even that very thoughtfulness and thoroughness might make one wish for more deference to the FDA.  

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Today’s message is a reminder that specific personal jurisdiction is just that – both specific and personal.  That means plaintiffs can’t group plead their way around personal jurisdiction lumping parents and subsidiaries together.  Plaintiffs must identify each defendant’s individual role in causing the alleged harm.  If plaintiffs seek to impute the jurisdictional contacts of one corporate defendant to another, they must first plead sufficient facts to raise a colorable claim that the companies are alter egos and the corporate veil should be pierced.  And in Texas, common use of a trade name by affiliated companies doesn’t meet that threshold.

In LaRocca v. Invasix, Inc., 2023 WL 2391012 (S.D. Tex. Mar. 7, 2023), plaintiff sued the manufacturer of a body contouring product that was used during a medical procedure alleging it caused her injury.  Plaintiff filed the suit against both the parent, an Israeli corporation, and its US subsidiary.  The foreign parent moved to dismiss asserting a lack of personal jurisdiction.  For specific jurisdiction to exist, a defendant must “purposefully avail itself of the privilege of conducting activities within the forum” and plaintiff’s claims must “arise out of or relate to” the defendant’s forum contacts.  Id. at *2-3. 

To start, the court quickly rejected plaintiff’s alter ego argument.  All of the proffered evidence supported that the defendants observed separate corporate formalities such as maintaining separate bank accounts and business records, separate offices, and separate employees.  Id. at *1 & *3.  So, to establish personal jurisdiction over the foreign defendant, plaintiff had to demonstrate that specific defendant “purposely directed its activities toward the forum state.”  Id.  But, it had no property, employees, or office in Texas; no agent for service in Texas; never marketed in Texas; had no contracts with anyone in Texas; and derived no revenue from Texas.  Id.  

That left plaintiff to focus on the trade name.  The foreign defendant was InMode Ltd.  The US defendant was Invasix, Inc.  The trade name by which the companies’ products are known is InMode.  Plaintiff pointed to two Invasix Texas employees who used InMode on their LinkedIn profiles and a LinkedIn position announcement that refers to InMode and a position in Texas.  Plaintiff also argued that a purchase agreement that used the name InMode was evidence that InMode Ltd entered into contracts in Texas.  But use of the common trade name, absent any evidence that corporate formalities were disregarded, is not sufficient to impute jurisdictional contacts.  Id. While this decision reached the right conclusion given the circumstances, this case warrants a reminder of our prior warning to our readers to make sure that their employees’ LinkedIn profiles are accurate and do not overstate potentially jurisdictionally relevant connections.  This is not the first plaintiff to make use of LinkedIn to try to establish jurisdiction. 

With the court unwilling to find that InMode the trade name meant InMode Ltd the company, plaintiff’s final effort was to argue that InMode Ltd.’s website established jurisdiction because it has a function that allows users to search for healthcare providers who use the company’s products.  But that too was an insufficient jurisdictional contact because it was not “directed to Texas in particular.”  Id. at *4.  As this is a common feature on product websites, this ruling establishes good precedent for an argument we expect we will see again.   With no purposeful contacts to support specific personal jurisdiction, the claims against the foreign defendant were dismissed.

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Starting with our comprehensive post lambasting Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448 (W.D. Pa. 2019), for ignoring 75 years of hitherto unbroken Pennsylvania precedent and allowing a “strict liability” design defect claim against an FDA-regulated prescription medical product, we have both chronicled and opposed the other side’s attempt to infiltrate strict liability into Pennsylvania litigation involving such products (primarily medical devices). That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 (Henderson) and 2014 (Lance), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) (Creazzo), all rejecting application of strict liability principles to prescription medical products.  For the gory details, see the prior post.

Continue Reading Pennsylvania Law, Federal Rules, and FDA Standards
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We have never been sued in Hawaii.  At least not yet.  It could be that someday someone will call us to task for eating too much shave ice or using the word “mahalo” incorrectly.  But so far we have traversed the Aloha State unscathed by legal exposure.  Our favorite Hawaiian island is Kauai, the Garden Isle (not to be confused with the Garden State, New Jersey), and we count hiking Kauai’s Waimea Canyon as one of the highlights of our vacation lives. 

The defendants in Yamashita v. LG Chem, Ltd., No. 20-17512, 2023 U.S. App. LEXIS 5268 (9th Cir. Mar. 6, 2023), were not so fortunate.  They got sued, but the news here is that the district court dismissed the claims for lack of personal jurisdiction, and the Ninth Circuit affirmed.  Moreover, the Ninth Circuit’s opinion very helpfully clarifies the Supreme Court’s most recent opinion on personal jurisdiction, Ford v. Montana. 

We wrote on the Supreme Court’s recent activity on personal jurisdiction just one week ago.  In a nutshell, the Supreme Court decided Bauman in 2014 and held that general personal jurisdiction would lie only where the defendant was “at home,” which for a corporation generally means the state of incorporation or its principal place of business.  By limiting general personal jurisdiction to those places, Bauman struck a blow against forum-shopping plaintiffs.  For specific personal jurisdiction, we have credited the Supreme Court’s opinion in Bristol-Myers Squibb in 2017 as restoring discipline in cases involving non-resident defendants and striking another blow against litigation tourism. 

Then came Ford, which held (in a case involving resident plaintiffs, i.e., not forum shoppers) that a court could take personal jurisdiction over claims that “arise out of or relate to” the defendant’s forum contacts.  That gloss on specific personal jurisdiction is not new, but what Ford added is that “arise out of” and “relate to” are alternatives, with “relate to” allowing a pathway to jurisdiction even absent a direct, causal nexus between the defendant’s forum contacts and the plaintiff’s claims.  In our view, the practical consequence of Ford is that forum residents bringing claims arising within the forum receive some leeway in establishing specific personal jurisdiction over non-resident defendants. 

The Supreme Court famously cautioned, however, that “relate to” does not mean “anything goes.”  Ford Motor Co. v. Montana Eighth Jud. Dist., 141 S. Ct. 1017, 1026 (2021).  To the contrary, the “relate to” prong still requires a close connection between the forum contacts and the injury.  In Ford, the plaintiffs resided in the forum and alleged injury in the forum, and the defendant had extensively marketed, sold, and serviced the exact product models at issue in the forum.  That was enough, even though the plaintiffs had purchased their specific cars in other states. 

The Ninth Circuit’s opinion in Yamashita provides a very useful comparison.  A Hawaii resident alleged an injury from a lithium battery that allegedly malfunctioned in a consumer device.  One defendant, however, was in South Korea and the other was a Delaware corporation with its principal place of business in Georgia.  Yamashita, at *6-*7.  Because neither defendant was “at home” in Hawaii (thus no general personal jurisdiction), the primary issue was specific personal jurisdiction. 

But unlike Ford, this forum resident alleging an injury within the forum fell short.  The plaintiff cited four “contacts”:  First, the defendants shipped products through the port of Honolulu, and some contained lithium batteries.  Second, one defendant sold residential solar batteries (i.e., a different product) in Hawaii.  Third, various consumer products sold in Hawaii contained the defendants’ lithium batteries.  Fourth, a third-party website sold the defendants’ batteries throughout the Internet-connected world, presumably including Hawaii. 

None of those contacts supported specific personal jurisdiction.  The shipment of products through the port of Honolulu constituted purposeful availment of the laws of Hawaii, but the record did not show whether any of those shipments included the battery model at issue.  The sale of residential solar batteries likewise was purposeful availment, but those were altogether different products, i.e., “as different as sedans and 18-wheelers.”  Id. at *20-*21.  Neither could satisfy the “arise out of” or “relate to” tests.

The other alleged contacts were even less relevant.  The sale of consumer products in Hawaii containing the defendants’ batteries (even if they were the exact same model as the battery at issue) shows only that the defendants placed their batteries in the stream of commerce somewhere.  The record did not show that the defendants “deliberately navigate[ ] the stream of commerce towards Hawaii, either by introducing these batteries into Hawaii [themselves] or by ‘creat[ing], control[ling], or employ[ing] the distribution systems’ which does so.”  Id. at *14 (quoting Asahi Metal).  Allegations that the defendants sold the batteries through a third-party website were not purposeful availment either.  The defendants denied that they authorized such third-party sales, and even if they had, there was no indication they targeted Hawaii.

The Ninth Circuit concluded that the plaintiff’s claims clearly did not “arise out of” these forum contacts, since there was no but-for causation link.  The plaintiff did not allege that the defendants shipped the subject battery into the port of Honolulu, and the one defendant’s solar batteries sold in Hawaii were completely different.  Id. at *19-*20.  The claims did not “relate to” the forum contacts either.  As the Ninth Circuit observed, “There is little reason to believe that either firm’s port contacts or [one firm’s] solar contacts have anything to do with Hawaii residents’ acquisition of [these particular] lithium-ion batteries.” 

The cherry on top is that the Ninth Circuit also affirmed the district court’s order denying jurisdictional discovery as unjustified:  “In sum, Yamashita has no viable route to establish personal jurisdiction.  Jurisdictional discovery would be little more than a fishing expedition seeking support for jurisdictional theories one of which is farfetched, and the other of which [the defendants] have specifically denied via sworn statements. . . .  [H]e has only a mere hunch that jurisdictional discovery will allow him to meet his burden.”  Id. at *25-*26. 

We like Yamashita because we take seriously the Supreme Court’s admonition in Ford that its opinion “does not mean anything goes.”  Whatever that means, we know at least two things in the Ninth Circuit.  First, while Ford might allow some leeway for forum residents alleging a forum injury, there are limits.  Mr. Yamashita resided in Hawaii and alleged an injury in Hawaii, but he still could not haul these defendants into Hawaii’s courts.  Second, to justify specific personal jurisdiction, a plaintiff’s claims must have a close connection to the defendant’s forum contacts, if not a but-for causal nexus.  This should certainly preclude the blatant forum shopping at which Bauman and Bristol-Myers Squibb took aim. 

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Duh.  We apologize for the depth of our profundity, but there are some legal principles we think are really obvious.  So obvious, in fact, that we might respond to question about these principles with this most dismissive of (clean) interjections.  (We were somewhat surprised to learn from the interwebs that duh was supposedly first used in 1943 as a demeaning imitation of an unintelligent person and sometime later as an interjection.  We cannot fathom how deprived tweens and teens of past generations were by their lack of duh as a standalone comeback, particularly to an older person.)  The issue teed up in Campbell v. Depuy Orthopaedics, Inc., No. 3:23-cv-00029, 2023 U.S. Dist. LEXIS 31015 (M.D. Tenn. Feb. 24, 2023), drew this response from us.  Considering the “ink spilled” on this issue in this more than a decade-old case made us shake our heads.

The issue at hand is whether a plaintiff should win partial summary judgment on an element of her case as to which she bears the burden of proof—in this case, medical causation—when the defendant does not have an expert on that element.  Of course not.  Pattern jury instructions often include some version of the phrase “the defendant does not have to prove anything.”  The Federal Rules for Civil Procedure include a provision for judgment as a matter of law, colloquially known as directed verdict.  Defense trial lawyers with a lot of, er, gumption have been known to rest at the end of plaintiff’s case without presenting any witnesses.  So, does a defendant have to present witnesses, expert or otherwise, on every issue as to which plaintiff bears the burden of proof?  Does something about Fed. R. Civ. P. 56 change the dynamic so an unopposed expert turns into partial summary judgment for the plaintiff?  No and no.

Frankly, the more interesting flip side to this coin is when the plaintiff files a “reverse Daubert” motion on the defense medical causation expert or otherwise seeks to require that the defense expert offer an opinion to a reasonable degree of medical probability/certainty as to what other than the defendant’s product caused the plaintiff’s alleged injuries.  The First Circuit addressed the latter issue well in Wilder v. Eberhart, 977 F.2d 673 (1st Cir. 1992), and courts usually get both of these issues right.  Taking this all a bit further (or nerdier), the burden on the plaintiff to prove her case by a preponderance of evidence connects to the requirement from Daubert II and Havner that epidemiologic studies supporting general causation must have statistically significant relative risk (or odds ratios) greater than 2.0.  A relative risk of exactly 2.0 indicates that half of the cases in a population will be due to the exposure and half will not.  But we digress from our digression.

The presented facts and procedural history of Campbell are simple.  Plaintiff had a hip implant in 2009, had pain beginning in 2011 that led to a surgical intervention, sued over alleged metallosis, had the case docketed in an MDL for a long time, relied on the implanting surgeon for her causation case, moved for partial summary judgment on causation when the defendant did not name an expert on causation, and had her case remanded from the MDL a while later.  It was unclear whether the defendant chose not to name an expert like an orthopedic surgeon to address case-specific medical causation or there was the sort of oversight by the defendant of the type that plaintiffs are permitted to wiggle out of far too often.  (We perused the docket for some more information, which we will discuss later.  The MDL was the Pinnacle Hip MDL, notorious for a very large verdict that was reversed by the Fifth Circuit.)  In any event, the remand court’s consideration of the plaintiff’s motion was mercifully succinct.

Citing a range of Tennessee cases, the Campbell court rejected plaintiff’s argument with “it is only the Plaintiffs who are required to present expert testimony to establish causation in cases where the plaintiff has suffered a complex medical injury.”  2023 U.S. Dist. LEXIS 31015, *5-6.  Plaintiff tried to rely on two federal cases applying Tennessee substantive law to grant a defendant’s motion for summary judgment because plaintiff did not have the requisite expert testimony, in one, and to deny a plaintiff’s motion “seeking relief from its obligation to submit case-specific medical expert testimony to prove causation of medical injuries,” in the other.  Id. at *6-7.  The court was having none of it.  More generally, a defendant can rely on the jury to reject plaintiff’s expert’s testimony, especially when aided by effective cross-examination.  Moreover, the implanting surgeon who tried to offer expert opinions for plaintiff noted “no significant metallosis” in the report for his revision surgery and otherwise lacked facts in the case supporting his opinion.  Id. at *9-10.  So, summary judgment was rightly denied.

That is all well and good, but we do have a gripe.  We have less than complete information on the history of the Pinnacle MDL and this particular case, but it looks like a poster child for some of the problems with MDLs.  The case was filed back on October 13, 2011, sat around inactive for most of the next eleven years, and ended up back in the local federal court on January 19, 2023, with plaintiff’s motion for partial summary judgment pending.  In the MDL, after plaintiff dropped out of the court’s mediation program, there was a flurry of activity starting with a show cause order on plaintiff’s failure to prosecute and ending with a suggestion of remand on December 30, 2022.  According to the JPML website, the Pinnacle MDL opened in May 2011, had about 10,500 cases in it, and is now down to 0 cases (but has not yet been terminated).  That history, even without the notoriety to which we alluded previously, does not speak to the “the just and efficient conduct of such actions” in § 1407.  By contrast, the remand court ruled on a pending motion for summary judgment within five weeks of transfer.  That is efficient no matter how obvious the outcome was.

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The plaintiffs in Acosta-Aguayo v. Walgreen Co., 2023 U.S. Dist. LEXIS 34836  (N.D. Ill. March 2, 2023), visited their friendly neighborhood drug store and bought a lawsuit.  Well, first they bought pain relief patches.  Those patches were over the counter (OTC) products.  No prescriptions were required.  Maybe those pain patches worked and maybe they didn’t.  We do not know.  We cannot tell from the court’s opinion.  But we do know that the plaintiffs decided to deliver some pain themselves, in the form of a putative class action (actually four classes – nationwide, multi-state, California, and Illinois) alleging that the drug store falsely trumpeted some of its pain-relief products (in both patch and cream form) as being “maximum strength” when, in fact, there were other products with higher concentrations of the pain medicine.  The plaintiffs brought claims for breach of warranties, unjust enrichment, common law fraud, and violations of various state consumer protection statutes.  The defendant moved to dismiss the case.  The court’s opinion was like a bag of stuff you might bring back from a drug store – some goodies and some stuff that might make you embarrassed.  

Yes, for the millionth time you’ve seen the phrase in this blog, the Acosta–Aguayo decision was a veritable mixed bag.

The court began with the issue of standing, so we will do the same.  The lawsuit addressed three products – two patches and one cream.  The plaintiffs alleged that they bought one of the patches, did not buy the other patch, and did not buy the cream.  The court held that the plaintiffs had standing to assert claims for the products they actually purchased, plus other “substantially similar products.”  The two patch products looked the same, so both remained in the case, but the cream product was different and was dressed in labels with different colors, images, and product descriptions.  The cream product’s packaging was a different size and shape, and its text bullet points and bubbles were different from the patches.  You might think the court is making solid points here, or you might think it is dancing on the head of a pin, but the truth is that the plaintiffs never explained exactly how the cream label was substantially similar to the patch labels.  That failure led the court to dismiss the claims regarding the cream products.

The defendant made another argument that related to standing, though the Acosta-Aguayo court dealt with it in a different section of the opinion.  The plaintiffs alleged 12 statutory consumer protection claims on behalf of the multi-state class under the laws of 12 states. So far, so good.  But the plaintiffs were not personally injured in and did not reside in most of those states.  So claims under those state laws should be dismissed, right?  Wrong, said the Acosta-Aguayo court.  It read cases in the Seventh Circuit and Northern District of Illinois to reflect a “prevailing view” that efforts to strike class allegations should be reserved for the class certification stage.  They would survive the pleading stage.  No pain relief there.

The most interesting issue in Acosta-Aguayo was whether the product labels were misleading.  According to the defendant, the OTC patches did contain the “maximum strength” of pain reliever medication in OTC products.  There were prescription products that contained higher doses, but so what? The defendant asserted that the OTC patches contained the maximum concentration permitted by the FDA in nonprescription external analgesics.  The label was not misleading.  Rather, the label was fully accurate.  Consumers coming into pharmacies without a prescription would not be able to buy any product that is stronger.  This argument by the defendant thoroughly persuaded our biased, flinty, defense-hack noggins.  But it did not persuade the Acosta-Aguayo court.  Here is the court’s answer to a defense argument that we thought was unanswerable:  “Yet Defendant does not argue that a reasonable consumer would know this fact.”  Our eloquent answer to this answer follows thusly:  Huh?  We simply do not get the court’s point.  It gives us a headache.  And anything less than maximum strength will not suffice to send such headache away.  But we will not get too exasperated by the Acosta-Aguayo’s leaps of illogic, because the court also says that at this pleading stage the plaintiffs “have raised a reasonable inference that for the Patch products, similar 5% lidocaine OTC products are available.  Whether Plaintiffs can prove this is a matter for another day.”  We don’t see how the plaintiffs managed to raise such an inference, but we’ll happily seize upon this alleged point as a point of distinction.  In the meantime, look for more class action strike suits over “maximum strength” product descriptions.  And while we are in such a jolly, life-affirming, constructive mood (the pain reliever must be working), we suggest that manufacturers use language (which we think we have seen) specifying that the product contains the maximum strength a consumer can get without a prescription.  The idea behind this language is to head off idiocy, but we will not specify whose.

And now that we’ve pulled out the grimmer items from the drugstore bag (the stuff that stings, pokes, and smells bad), let’s grab the candy.  In Acosta-Aguayo court dismissed the claim alleging that the defendant acted “unfairly,” because the plaintiffs mentioned no violation of any statutory or administrative rule.  The warranty claims flunked because the plaintiffs furnished no pre-suit notice.  The common-law fraud claim failed for lack of intent, since plaintiffs plead only negligence, and also because there is no duty to disclose in an ordinary buyer/seller relationship.  In a desperate attempt to fend off dismissal, the plaintiffs suggested that the drug store was a fiduciary, which seems patently silly, but the court rejected the argument not only on silliness grounds (no special relationship) but also because it is an “axiomatic rule that a plaintiff may not amend his complaint in his response brief.”  Finally, the court dismissed the claim for injunctive relief because there was no likelihood of future injury.  The plaintiffs “do not claim that they will purchase the allegedly mislabeled Products in the future.  Plaintiffs’ awareness of the alleged deceptive practice undermines the notion that they will likely sustain imminent injury.”  There is a price to enlightenment.

As we told you, Acosta-Aguayo is a mixed bag.  While the best parts of it do not completely erase the pain of the worst, we are, at this point, comfortably numb. 

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Just last week we updated our discussion on the 2023 amendments to Rule 702 urging our readers to start using the amendments now before their official implementation in December.  That’s because the Report of the Rules Advisory Committee confirms that the change to Rule 702 is to correct the mistakes of those courts who have opined that the basis of an expert’s opinion “only goes to weight, and not admissibility.”  Today we add to the discussion a prime example of why you should not wait. 

In Crockett v. Luitpold Pharmaceuticals, Inc., 2023 U.S. LEXIS 29923 (E.D.PA Feb. 23, 2023), the court denied defendant’s motion to exclude plaintiff’s expert under Rule 702 primarily concluding that the reliability issues raised by defendant went to weight rather than admissibility—a misapplication of Rule 702.  Specifically, the court’s analysis started with the false premise that “[w]hen reliability questions go to the weight of an expert’s proposed testimony rather than admissibility . . .”  Id. at *5.  But use of a reliable methodology is a condition of admissibility that must be established by a preponderance of the evidence.  It is not “an issue suitable for the jury.”  Id.

In Crockett, defendant challenged plaintiff’s expert’s opinion that the condition plaintiff suffered from was systematically underreported in clinical trials for the drug.  Defendant argued that the opinion was not based on a reliable methodology or supporting data.  Id. at *9.   In fact, the expert’s report referred to his theory as a “hypothesis” that “may have” led to underreporting.  Id. at *10.  The only basis for his “hypothesis” seems to be the expert’s “experience” that the complication occurs “way more” than what the trials reported.  The medical community lacks familiarity with the condition so they don’t report it, which perpetuates the lack of familiarity.  Circular reasoning supported by nothing other than personal “experience” is not proof by a preponderance of the evidence of reliability, absent which plaintiff has not met her burden of establishing admissibility under Rule 702.  But that’s according to us and the Rules Committee.  In Crockett, “defendants’ objections [went] to the weight of [the expert’s] testimony on underreporting, making them better suited for cross-examination.”  Id. at *11 (citing another case that does not survive the Rule change, Durando v. Trustees of Univ. of Pennsylvania, 2022 WL 2467080, at *1 (E.D. Pa. July 6, 2022)).   

The expert’s other opinions likewise appear to be largely based general experience and occasionally some unidentified medical literature.  For example, on the question of the latency period, defendant points to the absence of any citations in that section of the expert’s report.  The court, however, found his methodology sufficient because it was based on “extensive clinical research experience” and some unidentified medical literature identified as reference materials.  But it is not clear whether the literature was cited for the relevant propositions, as opposed to being mentioned somewhere else in the report.  Id. at *13.  On another opinion, defendant pointed to a lack of supporting data.  The court determined that that was a concern “better suited for cross-examination.”  Id. at *15.  But a lack of supporting data is also a criterion for admissibility, not an issue of weight.       

Finally, the decision refuses to consider an argument that the other risks the expert opines on are irrelevant to the case, as plaintiff did not suffer them because defendant raised the issue for the first time in its reply brief.  But the argument is based on an apparent concession in the plaintiff’s opposition papers, so it does not seem possible for the defendant to have made the argument any earlier.  Id. at *16.

Decisions like Crockett should not survive the rule change in December.  But more importantly, defendants should be doing what they can to prevent 10 more months of decisions like Crockett misapplying Rule 702.  The end of “basis only goes to weight” is near, but maybe we can help it along.

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What follows is from the non-Dechert side of the blog.

The history of the Zantac MDL has been one novel claim after another from the plaintiffs’ side.  Fortunately, the vast majority of those ideas have gotten nowhere.  That’s what most recently happened in In re Zantac (Ranitidine) Products Liability Litigation, ___ F.R.D. ___, 2023 WL 1797264 (S.D. Fla. Feb. 7, 2023).  The plaintiffs filed something entitled “Expedited Motion to Permit Multi-Plaintiff Complaints for Registry Claimants.”  This was the plaintiffs’ attempt to avoid paying filing fees for around 58,000 “registry claimants” − who are now obligated to make up their minds and file their complaints – or forever hold their peace.

Continue Reading Zantac MDL Zaps Crazy Consolidation Claims
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A couple of our recent posts have mentioned the alternative compensation system created by the 1986 National Childhood Vaccine Injury Act (“Vaccine Act”), 42 U.S.C. §§300aa-10, et seq.

This Vaccine Program is the Act’s alternative to tort litigation, which addresses alleged injuries resulting from vaccines covered by the Vaccine Act.  The legal aspects of the Vaccine Program are administered by the Department of Justice, and here’s a link to government’s description of the program

For decades, the Vaccine Program has been successful in protecting the nation’s childhood vaccine supply, and stands as one of Congress’ most effective limits on the destructive use of mass tort litigation.  The other side, which opposes any restraints on tort litigation, would love to see it fail.  Our recent posts have detailed their attempts to do just that through exposing the Vaccine Program to mass tort litigation tactics that the program, with its statutory limit of “not more than 8 special masters,” 42 U.S.C.A. §300aa-12(c)(1), is ill-equipped to withstand.

But ill-equipped does not mean unequipped, and that’s what this shameless plug is about.

The U.S. Department of Justice, which defends Vaccine Act claims in the Court of Federal Claims, is hiring.  If any blog reader is interested in defending both vaccines and the Vaccine Program, then we encourage you to think about applying.

The Office of Vaccine Litigation recently posted for a whopping twelve positions to –according to the posting − “address workload created by an increase in cases filed under the Vaccine Act.”  The posting is available on DOJ’s website and at USA JOBS.  These are GS 12-14 positions with starting pay (depending on experience and seniority) between $94,199 and $172,075 per year.  Promotions to the GS 15 pay level are common.

These positions are a great fit for anyone who has practiced mass tort defense, and in particular those who love digging into the science, working with expert witnesses, and actually presenting cases to the special masters who try them.  The job descriptions also point out that the DoJ attorneys in the Vaccine Program typically get to handle all program-related appeals to the Federal Circuit.  So hands-on appellate experience comes with these jobs, too.

We think that these specialty DoJ positions would be an excellent fit for younger, defense-oriented attorneys who enjoy defending products like vaccines, but who would like more hands-on and in-court experience than big firms like ours are often able to provide.

Photo of Rachel B. Weil

We’ve started thinking that it might be fun to run for a seat on our county’s (elected) trial court bench, when we retire from our law firm.  (Our current campaign is for our township’s school board.  If we succeed, our term will take us just about to the point at which we plan to retire).  Cases like today’s strengthen our resolve.  In a world filled with COVID, mass shootings, melting glaciers, and MAGA rumblings, a touch of the absurd goes a long way to pass the time.  We confess that we looked to see if the plaintiff in today’s case was proceeding pro se – that’s how little sense any of it made.  And we kept thinking how much fun we would have had writing the opinion. 

In Atoe v. Orthopediatric United States Distrib. Corp., 2023 U.S. Dist. LEXIS 26983 (W.D. La. Jan. 26, 2023), the plaintiff filed suit in state court, alleging claims on behalf of her minor child for injuries she alleged the child sustained as a result of an orthopedic surgical procedure she underwent.  The plaintiff claimed that the child’s injuries were caused by a defective medical device and by medical malpractice, and she sued the hospital and a doctor along with defendants in the device’s supply chain.  At about the same time, she went before a medical review panel that considered her medical malpractice claims against the medical defendants named in her suit along with one other doctor.  Once the panel was convened, the plaintiff dismissed the medical defendants from the lawsuit, “presumably,” according to the court, “to allow for exhaustion of the claims against those malpractice defendants through the medical review panel process.”  Atoe, 2023 U.S. Dist. Lexis 26983 at *1-2.  That’s how medical malpractice works in Louisiana.  The remaining defendants removed the case to federal court, asserting diversity jurisdiction.  The defendants filed their answer in federal court, and the court entered a scheduling order that included a trial date. 

Meanwhile, the medical review panel rendered its decision, so the plaintiff was able to file suit on her previously-dismissed malpractice claims against the hospital and the doctors.  But she did not amend her complaint to add those defendants; instead, she filed a separate suit in state court against them.  Once that suit was filed, the plaintiff moved to remand the federal proceeding (against the product liability defendants), arguing that the court no longer had diversity jurisdiction because of the separate lawsuit.  We kid you not. 

The court commented: 

Plaintiffs in cases that involve products liability and medical malpractice often file suit against the products defendants first.  Those defendants are usually from out of state, so the case is filed in or removed to federal court based on diversity jurisdiction.  After the medical review process is completed, the plaintiff will seek leave to amend the complaint and add the malpractice defendants to the case.  That often results in the destruction of diversity because the plaintiff/patient and physician/hospital are typically citizens of the same state.  But that is not the case here. 

Id. at *4.  In this case, even joinder would not have destroyed diversity, because complete diversity existed between the plaintiff and the medical defendants.  But that is neither here nor there.  Obviously, the malpractice defendants, in their own state court proceeding, could not destroy diversity jurisdiction in the federal lawsuit, because IT WASN’T THE SAME CASE.  The court postulated that, given the diversity between the plaintiff and the malpractice defendants, the plaintiff was likely thinking of the forum defendant rule.  One of the malpractice defendants was a Louisiana resident, so the case would not have been removable while that “forum defendant” remained joined.  But that individual’s citizenship in the forum state was not relevant BECAUSE HE WAS NOT A PARTY TO THE FEDERAL LAWSUIT.  Nor did the court credit the plaintiff’s argument that it would be more efficient for the court to remand the federal case so both cases could be litigated together in state court.  As the court emphasized, concerns of judicial efficiency “do not allow for remand,” as “[f]ederal courts have a virtually unflagging obligation to exercise their jurisdiction.”  Id. at *6 (internal punctuation and citations omitted.).  Finally, the plaintiff could not take advantage of “abstention” to seek a stay the federal case, because that doctrine applies only to cases involving the same parties and the same issues.  Here, the state and federal complaints named different parties and asserted different legal theories.

To this point, the court was fairly restrained, though we could imagine the inevitable eye rolling and chuckling.  To wit, the court stated, “Plaintiff can file all the additional lawsuits she wants in state court and it will never destroy diversity in this case.”  Id. at *7.  Why?  BECAUSE THEY WILL NOT BE THIS CASE – THEY WILL BE SEPARATE LAWSUITS.  The court continued, “If plaintiff believed that it was more efficient to try the products liability and medical malpractice claims in a single forum, she should have attempted to join the medical malpractice defendants in this case.”  Id, BUT SHE DIDN’T!!

Concluding that “none of the arguments made by Plaintiff require[s] or allow[s] for remand,” the court (obviously) denied the motion.  We got a little lift from reading Atoe – not sure what that says about us.  But we’ll take it.  Stay safe out there.

Drug & Device Resources

Bexis’ Book

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