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We are not speaking for anyone else (clients, colleagues, our firm, etc.)  when we say that drug and device product liability cases should be patterned after the Vaccine Act (42 U.S.C. Section 300aa-1 et seq.).  It is faster, fairer, more predictable, and cheaper for everyone.  From the defense side, we like that actions under the Vaccine Act will not be decided by runaway juries.  And we suppose that is the main reason why plaintiff lawyers abhor the Vaccine Act and do whatever they can to avoid it.

In re Gardasil Products Liab. Litig., 2024 U.S. Dist. LEXIS 135736 (W.D. N.C. July 31, 2024), is a multidistrict litigation (MDL) that should never have existed. In this recent decision, yet another plaintiff effort to sidestep the Vaccine Act compensation system failed.  To our jaundiced, defense hack eyes, it appears that this is an entirely predictable instance of a vast plaintiff MDL client solicitation dredging up stale plaintiffs. The problem for the four plaintiffs at issue here is that filing a Vaccine Act claim in “Vaccine Court” is a prerequisite to any subsequent civil suit.  “[N]o one may bring ‘a civil action for damages’ against a vaccine manufacturer ‘for damages arising from a vaccine-related injury” unless she has first timely filed and exhausted a petition for compensation in the U.S. Court of Federal Claims.” You noticed that word “timely,” right?  One of the four plaintiffs never filed a claim in Vaccine Court at all, while the other three plaintiffs filed belated petitions with the Vaccine Court, which were thrown out on timeliness grounds.  The Vaccine Act requires that a petition for compensation must be filed within 36 months of “the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of [a vaccine-related] injury.”

The plaintiff who never filed a claim in Vaccine court ended up giving up, and did not respond to the defendant’s motion to dismiss the MDL claim.  Adios. The other three plaintiffs did not go down without a fight.

To avoid the defense motions to dismiss, the three plaintiffs who had been bounced from the Vaccine court on timeliness grounds collaterally attacked the Vaccine Court judgments dismissing their cases. They also made the inevitable request for relief under a discovery rule, and made weak equitable tolling arguments that involved only general allegations with no direct contact between the defendant and the plaintiffs. 

The MDL court rejected the collateral attack on multiple grounds.  First, as a matter of procedure, the MDL court held that it had no power to second guess the Vaccine Court’s decision.  “[T]he decision as to the application of the Vaccine Act’s limitations period to petitioners in the Vaccine Court is properly decided by those Special Masters.”  Nothing in the Vaccine Act empowers courts in subsequent civil actions to review Vaccine Court decisions.  The plaintiffs pushed hard for de novo review. But they are separate proceedings.  Moreover, the MDL court reasoned that Vaccine Act timeliness should not turn on the vagaries of different states’ laws. In any event, there is no mechanism whereby a reviewing district court could remand a case to Vaccine Court.  All of which suggests that a collateral attack on Vaccine Court decisions is simply unavailable.

What the plaintiffs were really seeking here was a way to bypass the Vaccine Court altogether, in ex post facto fashion.  The MDL court was not having that. 

Then the MDL court did something smart.  After holding that it could not review the Vaccine Court’s determinations of untimeliness, it held that it would sustain the untimeliness finding even if it did conduct such a review.  The discovery rule does not apply to the Vaccine Act.  Then the court held that there were no circumstances external to the plaintiff’s own conduct that could justify tolling.  There was no showing of diligence and extraordinary circumstances.  Instead, the plaintiffs’ equitable tolling argument was premised on non-individualized, vague allegations of “fraud” and “concealment.”  In essence, the equitable tolling argument merely repackaged the discovery rule arguments under another name. “In sum, even if the Court were empowered to decide the issue of ‘equitable tolling’ de novo, it would reach the same conclusion that the Plaintiffs’ Vaccine Court petitions were untimely and dismiss their claims on that basis.”  Now, even if there is an appeal to the Fourth Circuit, and even if the Fourth Circuit disagrees with the determination of unreviewability, it can still affirm the dismissals.  

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This is our second go round with Vardouniotis v. Pfizer, Inc., Case No. 152029/2019 (N.Y. Sup.).  When we posted about the court’s decision on defendant’s motion to dismiss, we were resigned to shrug our shoulders and accept that “nothing’s perfect.”  It’s two years later and we’re still shrugging.

After the court allowed plaintiff’s negligence; gross negligence; willful, wanton and malicious misconduct; breach of implied warranty; and unjust enrichment causes of action to proceed, fact and expert discovery moved forward, including the production of plaintiff’s voluminous medical records.  Vardouniotis, 2024 WL 3345021, *4 (N.Y. Sup. Jul. 8, 2024).  Plaintiff claimed her 11-day use of Chantix caused her to develop a movement disorder.  The opinion details the treatment plaintiff sought for this condition including seeing ten different neurologists and undergoing multiple diagnostic tests like MRIs, EEGs, EMGs, and nerve conduction studies—none of which found a neurological basis for plaintiff’s abnormal movements.  Id. at *1-2.  Nor did any of plaintiff’s treaters diagnose a cause for plaintiff’s abnormal moments other than psychogenic or malingering.  Id. at *2.  Except one—the one she sought out because he had co-authored an article reporting two cases of movement disorders after use of Chantix.  The one who became plaintiff’s only causation expert.    

On general causation, plaintiff’s expert’s theory was that Chantix caused “excessive dopamine transmission” that can result in movement disorders.  Id. at *9.  His opinion was based on three studies, but none “draw a causal connection between” Chantix and any movement disorders.  Two of the studies do not address plaintiff’s claimed injury, and the third is about the risks of dopamine release caused by smoking, not by Chantix.  Id.  Moreover, “proof of a risk, even an increased risk, does not constitute proof of causation.”  Id. 

Plaintiff’s expert had “no controlled clinical studies, epidemiological data, or peer reviewed studies demonstrating a causal link” between defendant’s drug and any movement disorder.  Instead, he relied on five case reports.  However, “case reports are not generally accepted in the scientific community on questions of causation.” Id.   Indeed, three of the case reports here were “circumspect regarding causation,” and another attributed the patient’s movement disorder to stopping smoking, not to the effects of Chantix.  Id. at *10.  Finally, plaintiff’s expert cited an article summarizing post-market adverse event reports.  But the article itself did not reach any causation conclusion and specifically warned that “adverse event reports in themselves do not establish a causal link to the drug.”  Id.  Therefore, plaintiff’s general causation evidence was not based on a generally accepted methodology and was excluded. 

While the court’s ruling on general causation disposed of plaintiff’s expert’s specific causation opinion as well, the court conducted a separate specific cause analysis.  To reach his specific cause opinion, plaintiff’s expert relied on his own treatment and examination of plaintiff, and the medical records and testimony of her primary care doctor and her pain management doctor.  He chose not to review the medical records of the nine other treating neurologists, her multiple diagnostic tests, her numerous emergency room visits and hospitalizations, or any of her other medical providers.  Id. at *11.  All records that largely question whether plaintiff actually has any injury at all.  He disregarded “numerous and repeated notations by various treatment providers linking the plaintiff’s complaints of abnormal movements, and her efforts to obtain opioid medication as a treatment for her purported condition, to her suspected opioid use disorder and malingering.”  Id. 

Plaintiff tried to argue that the difference of opinion between her expert and her other treaters was an issue for the jury, but that missed the point.  “[T]he issue is not that other doctors reached a different diagnosis, but that [plaintiff’s expert] ignores and fails to specifically address those inconsistent diagnoses and the findings upon which they were based.”  In other words, plaintiff’s expert chose to ignore the overwhelming medical evidence that contradicted his litigation-driven opinion and made no attempt to rule out the findings of those other treaters as possible causes.  

And then plaintiff doubled down by submitting an affidavit from her expert asserting that he did not need to review the other treaters’ records because “those doctors are simply inferior physicians whose findings may be summarily discounted.”  Id. at *12.   Another mortal struck down by hubris. 

Without expert causation evidence, general or specific, defendant moved for summary judgment—which we think should have been a gimme.  And while the court agreed that plaintiff needs expert evidence on this type of complex causation issue, the court was unwilling to accept defendant’s assertion that the excluded expert was plaintiff’s only expert on causation.  Id. at *6, 12.  One would think that if plaintiff had such additional evidence, she would have proffered it in opposition to the motion.  So, while we are left shrugging our shoulders for now, we assume the dismissal on causation has merely been kicked down the road a bit.       

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The Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), has generated more commentary than anyone could possibly read.  Reed Smith alone has issued four Loper Bright alerts and established a resource center.  Overall, we think that Loper Bright’s assertion that judges know better than administrative agencies how to interpret and apply those agencies’ organic statutes smacks of judicial triumphalism.  However, it is what it is, and we’ll be living with it for some time.

Loper Bright essentially tells courts to ignore administrative interpretations and to give statutes “the reading the court would have reached if no agency were involved,” 144 S. Ct. at 2266 (citation and quotation marks omitted).  One thing that we (and Mark Herrmann, who first suggested this topic) haven’t seen in any commentary on Loper Bright are the implications of that mandate on the FDA’s questionable basis for its ban on all “off-label promotion” – particularly truthful off-label speech – by the firms it regulates.

Continue Reading Could Loper Bright Finally Do in FDA’s Rickety Off-Label Speech Ban?
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Although today’s decision involves a medical product, it focuses on an online marketplace rather than a drug or device manufacturer. And by online marketplace we mean the delivery service that has become ubiquitous in almost all of our lives—Amazon.  The decision is significant because it finds Amazon, as a shipper rather than a seller, does not have an independent duty to investigate risks of the products it ships.

Continue Reading Pennsylvania Federal Court Holds Online Marketplace Has No Duty to Inspect Goods
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Without detouring into a larger discussion on the impacts of humans on the environment and our fellow animals, we can say that we are big fans of the other extant great apes.  Our puppy’s fascination with nature documentaries has helped pique that interest of late.  Our gingery cousin the orangutan, the largest primarily arboreal mammal, has seen its population decline by about 75% over the last hundred years.  Changes to the palm oil industry and ecotourism provide some hope that the decline can be reversed.  Of course, most people will not have a chance to see an orangutan at home in the wilds of Borneo and would have to visit a zoo or nature park to see one in person.  Because they are smart, strong, dexterous, and adept climbers, orangutans are sometimes used to see if an enclosure intended for another animal is escapable.  (Apparently, octopuses are asked to fulfill a similar function for marine enclosures.)  That may be cool or cruel, depending on your perspective.

We offer this introduction because of the issues in Holliman v. CooperSurgical, Inc., No. X10-UWY-CV-23-6071739 S, 2024 Conn. Super. LEXIS 1486 (Conn. Super. July 19, 2024).  The plaintiff lawyers in that case and the three others with which it has been consolidated brought 103 plaintiffs from other states to Connecticut in the hope that they can stick in state court and get favorable product liability law.  This is old fashioned litigation tourism, which had been in decline for a decade before a clear shift last spring.  See here and here, but also here and generally here.  When successful, this brand of tourism is not good for anyone other than the plaintiffs and their lawyers.  Connecticut is not the most exotic destination in general and certainly not one that traditionally comes to mind as a litigation tourism destination.  Decisions such as one of the first post-Riegel express preemption wins to the rejection of innovator liability generally outweighed a looser design defect test and some holes in the state product liability act.  However, a relatively recent bad preemption decision has made Connecticut a destination for enterprising plaintiff lawyers.  Are we saying that plaintiff lawyers are like orangutans?  No, that would not be fair to orangutans.  The former do, however, come up with ideas about how to get in and stay in state courts they think will be favorable for them.  In this way, they are somewhat like anti-orangutans.  (We have also seen some whose paper practices promote deforestation.)  While some might praise the creativity and persistence of the plaintiff lawyers in these efforts, we have familiarity with the injustices and costs that can result from them.

The plaintiffs in Holliman and its fellow traveler cases advance product liability claims concerning Filshie Clips, a class III medical device used for tubal ligation.  We have discussed prior efforts at similar claims asserted in various federal courts over the last two years.  They have been a mixed bag, but most have found some or all of the claims are preempted.  See here, here, here, here, and here.  The best chance for a plaintiff in one of these cases to avoid the obvious express preemption under Riegel is to get a court to buy that there is a state law claim for not providing certain information to FDA that is somehow not predicated on fraud on FDA and, thus, impliedly preempted under Buckman.  Connecticut has now recognized such a nonsensical claim, which we assume is why the 103 non-Connecticut residents sued in Connecticut state court.  Well, that plus the fact that one of the defendants allegedly has its principal place of business in Connecticut.

The issue teed up in Holliman, at least for now, was whether Connecticut could exercise personal jurisdiction over the other three defendants, none of which was incorporated in or allegedly had its principal place of business in Connecticut.  When we said earlier that litigation tourism had been in decline for a decade, that started with Supreme Court’s 2013 decisions in Walden and Bauman, which collectively made it harder to impose either specific or personal jurisdiction over a defendant in the typical litigation tourism situation.  It took some time for trends rejecting plaintiff tactics like misjoining a bunch of foreign plaintiffs into a single case with at least one local plaintiff and attempting to re-characterize insufficient general jurisdiction contacts as specific jurisdiction contacts (or vice versa).  Still plaintiffs looked for ways to pursue cases in jurisdictions having no connection to their own claims, preferably (from their perspective) in places where the federal courts are not friendly to removal.  The pro-tourism decision from the Supreme Court last year in Mallory, however, hinged on a registration statute as a vehicle for general personal jurisdiction by consent.  In addition to being wrongly decided, Mallory is not going to cover all of the claims against all of the deep pocket non-resident defendants that non-resident plaintiffs will want to sue in a preferred jurisdiction.  Remember, a proper personal jurisdiction analysis should be claim-by-claim and party-by-party.

Most personal jurisdiction decisions involve looking at whether a state’s long-arm statute can create jurisdiction over the claim(s) against the defendant(s) consistent with Due Process.  In Mallory, the Pennsylvania long-arm statute purported to create general personal jurisdiction for state courts over corporations based on, inter alia, “(ii)  Consent, to the extent authorized by the consent[; or] (iii)  The carrying on of a continuous and systematic part of its general business within this Commonwealth.”  The foreign corporate defendant in Mallory had registered to do business in Pennsylvania and its registration was found to be the consent needed for general personal jurisdiction through the long-arm statute without running afoul of with Due Process.  In Holliman, the three foreign corporate defendants had not registered to do business in Connecticut and contended that the Nutmeg State’s long-arm statute did not cover the claims against them; they also asserted due process arguments, but the court did not have to reach those.  The analysis varied somewhat by defendant, a British designer and seller, its Utah parent, and the Delaware/California parent of the Delaware/Connecticut distributor that did not move to dismiss.  As noted, none of the plaintiffs were from Connecticut.  In addition, by contract, the distributor took possession of the devices in the UK, not in Connecticut.  Those facts meant that there was no argument in favor of specific personal jurisdiction over the movants.

As we have noted in various contexts, burden matters.  Here, Connecticut law provides that the typical burden on the defendant to disprove personal jurisdiction sensibly shifts to the plaintiff when the defendant is not a resident of Connecticut.  2024 Conn. Super. LEXIS 1486, *5-6.  The applicable Connecticut long-arm statute subsection provides as follows:

(f) Every foreign corporation shall be subject to suit in this state, by a resident of this state or by a person having a usual place of business in this state, whether or not such foreign corporation is transacting or has transacted business in this state and whether or not it is engaged exclusively in interstate or foreign commerce, on any cause of action arising as follows: (1) Out of any contract made in this state or to be performed in this state; (2) out of any business solicited in this state by mail or otherwise if the corporation has repeatedly so solicited business, whether the orders or offers relating thereto were accepted within or without the state; (3) out of the production, manufacture or distribution of goods by such corporation with the reasonable expectation that such goods are to be used or consumed in this state and are so used or consumed, regardless of how or where the goods were produced, manufactured, marketed or sold or whether or not through the medium of independent contractors or dealers; or (4) out of tortious conduct in this state, whether arising out of repeated activity or single acts, and whether arising out of misfeasance or nonfeasance.

CT Gen. Stat. § 33-929.  On its face, it does not provide for jurisdiction over the product liability claims of non-Connecticut individuals against non-Connecticut corporations.  The court in Holliman agreed:  “[P]laintiffs fail to sustain their burden of proving the court’s personal jurisdiction over the moving defendants pursuant to § 33-929(f).”  2024 Conn. Super. LEXIS 1486, *13.  Like the cagey anti-orangutans of our introduction, the plaintiff lawyers offered up two ways to keep the British designer/seller and the distributor’s Delaware/California parent in the case—they abandoned the Utah company—but their arguments went nowhere.

As to the British designer/seller, plaintiffs contended that it was required to register to do business in Connecticut and that its failure to do so created in personal jurisdiction under a different subsection of the long-arm statute, which says directly that “Every foreign corporation which transacts business in this state in violation of section 33-920 shall be subject to suit in this state upon any cause of action arising out of such business.”  The court did not to address all aspects of this subsection or the registration requirement because no claim in the case could have “aris[en] out of” business in the state by the defendant.

In this case, the evidence shows that the Filshie Clip product at issue was designed and manufactured in the United Kingdom; the fact that the product’s distributor has a principal place of business in Connecticut is, at best, tangential to the plaintiffs’ claims.  Importantly . . . given that none of the plaintiffs here is a resident of Connecticut, presumably, the placement of the clips, the plaintiffs’ exposure to the clips, and the negative consequences thereof, occurred outside of this state.

Id. at *28.  In other words, because this is litigation tourism, Connecticut’s long-arm statute provision relating to specific personal jurisdiction—which closely tracks the language of the Supreme Court’s Bristol-Myers and Ford decisions—was not met.

The analysis for the distributor’s parent company, which was incorporated in Delaware and had its principal place of business in California, was a little more complicated.  Plaintiffs claimed that the distributor was an alter ego of the parent and its contacts should be imputed.  Because both the distributor and its parent were incorporated in Delaware, Delaware law applied to the attempt to pierce the corporate veil.  Id. at *14.  As one might expect from the little state that is the locus of incorporation for the majority of large U.S. companies, Delaware’s corporate veil is nigh on impenetrable.  Without delving too deeply into the fact-specific analysis, suffice it to say that the parent and sub were separate enough despite overlapping leadership, overlapping inside and outside counsel, and other examples of control by the owner.  It is somewhat ironic that the plaintiffs, who could have sued in Delaware as easily as in Connecticut, were foiled by Delaware law.  Such are the vagaries of litigation tourism.

So, the non-moving distributor with its principal place of business in Connecticut is the only one left in the case.  Assuming plaintiffs do not dismiss and try again elsewhere with some or all of the original defendants, the distributor would appear to have a range of options.  One would be removal, either because of diversity or under CAFA, depending on the details of the consolidation order.  If successfully removed, the case would land within the Second Circuit, which rendered the preemption decision the Supreme Court affirmed in Riegel.  In the seventeen years prior to Glover, the District of Connecticut and Second Circuit had been pretty good on PMA preemption.  Thus, the plaintiffs could end up getting stuck in a court they did not want to be in even though they booked the trip to Connecticut in the first place.

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We have often characterized judicial options as mixed bags, and a recent example of such a mixed bag can be found in Muldoon v. DePuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 130020 (N.D. Cal. July 23, 2024). The plaintiff claimed injuries from a ceramic-on-metal hip implant.  He alleged that friction and wear caused the implant to release toxic metal ions and particles into his body.  The plaintiff initially filed a class action. That case was sent to a Multidistrict Litigation, was later remanded back to the original court, and then was refiled as a Second Amended Complaint (SAC) that eliminated the class action allegations. 

The defendants moved to dismiss the SAC in its entirety.  When we say “entirety,” we are talking about a ridiculously overpleaded complaint.  There were claims for (1) negligence, (2) strict liability, manufacturing defect, (3) strict liability, design defect, (4) strict liability, failure to warn, (5) strict liability, failure to test, (6) strict liability, breach of express warranty, (7) strict liability, breach of implied liability, (8) fraud, (9) negligent misrepresentation, (10) false advertising, (11) violation of consumer legal remedies act, (12)  violation of unfair competition law, and (13) civil RICO. It is a mess.  It is a dog’s breakfast. Or it is what our dogs deliver to our yard right after consuming their breakfast. And, for the most part, the plaintiff gets away with it. 

Preemption

The defendant raises an interesting and not often litigated preemption argument that a subsequent FDA premarket approval (PMA) encompassing what defendant stated were the same components implanted in the plaintiff when they were only §510(k) cleared supports preemption.  The court held that a fact issue as to whether plaintiff’s surgery actually involved those same components precluded Rule 12 dismissal, but there is law to the effect that a subsequent PMA supports preemption in pre-approval uses of the same device.  This significant issue has merely been postponed, because this factual predicate is something that a defendant should be able to determine and demonstrate conclusively.  

Negligence

The court held that “the plaintiff’s allegations that the product actually degraded inside his body are sufficient to please a breach of duty.” And now we know that this opinion is likely to spoil our (non-dog) breakfast. 

Manufacturing Defect

The plaintiff’s manufacturing defect claim should have been dismissed because there was no allegation of deviation from manufacturer standards, but the court allowed it, citing to allegations that, as to deviation, were a non sequitur.  The implant “broke apart and created metallic debris on his body, and/or the parts became loose or detached from each other.”  That was not supposed to happen. Ergo, manufacturing defect. That is, of course, a complete avoidance of the manufacturing defect issue. Groan. 

Design Defect

Defense hacks are quick to grouse over California product liability law, but California law is actually pretty good and very clear that prescription drugs and medical devices cannot be the target of a design defect claim.  (The court discussed the immunity of implanted medical devices, but as we have discussed before, the immunity should apply to any medical device that requires a doctor’s prescription). Accordingly, the strict liability design claim was dismissed with prejudice.  The plaintiff attempted to salvage the design defect claim by arguing that only PMA devices are exempt from design claim, but that theory was bereft of any legal support at all.  At this point, bringing a design defect claim against prediction medical products in California borders on the frivolous.  

Failure to Warn

The decision botches the warning claim, asserting that the learned intermediary rule is an affirmative defense.  The brand-new Himes California Supreme Court decision definitively held that it is not.  The opinion doesn’t mention Himes, and cites only a non-learned intermediary decision for the contrary proposition.  Anyway, because the defendant  did not demonstrate that the warnings to the doctor were adequate (completely reversing the burden), the court denied the motion to dismiss the failure to warn claim. 

Failure to Test

Failure to test does not state a claim in California. It is not an independent cause of action.  Rather, failure to test “is subsumed under claims for negligence, design defect, or manufacturing defect.”  This claim was dismissed with prejudice. Yay. 

Warranty Claims

Under California law, express warranty claims require privity, unless the plaintiff read and relied on a specific representation of the defendant.  As the SAC did not allege either privity or the exception, that claim was dismissed, though with leave to amend. (In resisting the motion to dismiss, the plaintiff argued that he did, in fact, rely on claims made to him by the manufacturer.  But that allegation resided nowhere in the SAC). Further, privity is absolutely required for implied warranty claims.  If the plaintiff seeks to amend to allege privity, he must attach documentary proof.  

Fraud Specificity

The misrepresentation and consumer statutory claims were all governed by the specificity requirement of Fed. R. Civ. P. 9(b). The plaintiff’s SAC did not provide the what/where/when details of any misrepresentation, and therefore failed to satisfy Rule 9(b) specificity as to the negligent misrepresentation, fraud, and consumer protection claims.  Significantly, the court held that an assertion that a product is “safe” or “effective” “generally constitutes unactionable puffery.” 

Consumer Legal Remedies Act

The court held that the plaintiff had not shown that he was a consumer for purposes of the CLRA.  He needed to show that he had engaged in a “consumer transaction” relating to the goods at issue. But the plaintiff can save this claim if he produces “documentary proof of the purchase in the form of an invoice, receipt, and/or specific details of payment.”  Judge Wapner in the old version of The People’s Court was always demanding that litigants produce receipts.  He, too, was a California judge. Good times. 

RICO

We wish courts would pronounce that RICO claims are simply unavailable in product liability cases. Sadly, that is not the law in California. Even so, the plaintiff’s SAC failed to allege any RICO element, including enterprise, pattern of racketeering activity, predicate acts, and “California tort(s) that form(s) the basis of plaintiff’s damaged property right with specificity and how the injuries relate to the torts.”  The plaintiff will doubtless try again. 

Punitive Damages

Punitive damages is not a claim. It is a remedy. Because the failure to warn claim survived the motion to dismiss (it shouldn’t have), it “could theoretically support an award of punitive damages.”  The court refused to dismiss or strike the plaintiff’s election of punitive damages. 

Judicial Notice

The court agreed with the defendants’ request for judicial notice of FDA documents.  Perhaps that judicial notice will support the inevitable part 2 preemption argument that is probably being written while you read this post. 

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We have not shied away from letting our readers know what we think of the Bair Hugger litigation.  And it’s not good (check it out here).  Plaintiffs’ latest defeat is the affirmance of a defense verdict by the Missouri Court of Appeals.  O’Haver v. 3M Company, 2024 WL 3034549 (Mo. Ct. App. Jun. 18, 2024).  Once again, plaintiff performed dismally.  Plaintiff raised nine appellate evidentiary issues.  None were meritorious. 

The first five issues are variations on a theme – plaintiff was not allowed to go beyond the scope of the direct examination and cross-examine defendant’s experts about various exhibits that the experts never considered in reaching their opinions.  Id. at *2-4.   All of the exhibits except one were otherwise already in evidence.  In each instance, the expert testified to either not relying on or having never seen the exhibit in question.  Id.  However, when the trial court disallowed any further questioning about those exhibits, plaintiff made no contemporaneous offers of proof regarding the cross-examinations she was denied.

Plaintiff argued that no offer of proof was necessary because an offer would not have changed the trial court’s decision and is only necessary to establish relevance, which she claimed was “self-evident.”  Id. at *4.  But that ignores another important purpose—to preserve the record for appeal.  Id.  Appellate courts review the admission of evidence at trial for prejudice.  However, if the court has

no record of how the expert witnesses would have testified had the cross-examination proceeded, [it has] no idea the impact that testimony would have had on the credibility of the witness, and, by extension, whether it would have had any impact on the outcome of the trial. 

Id. Because plaintiff did not adequately preserve these issues, she could not demonstrate prejudice, and each of her first five evidentiary appeals were denied.

Plaintiff’s next point was that she was prejudiced when the trial court sustained defendant’s objection to cross-examination questions that “invaded the province of the jury.”  Id. at *5.  Plaintiff repeatedly asked the defense expert whether he could exclude the Bair Hugger device as a potential cause of plaintiff’s injuries.  The expert repeatedly testified he could neither rule it in nor rule it out.  But plaintiff went too far when she asked the expert whether “it was a potential cause for this jury to consider in determining whether it contributed to her [injury].”  Id. Plaintiff argued that by cutting off that question, the jury was left with the “false impression” that the device was not a potential cause it could consider.  The appellate court found no prejudice to disallowing this one question where the expert testified “at least six times” he could not exclude the device as a cause.  Id.

Plaintiff’s next point was that it was error to limit her cross-examination due to defendant’s expert’s scheduling limitations.  The expert had planned to testify later in the schedule, but during a pre-trial conference one week before trial, it was clear that due to the dismissal of several defendants and issues, the witness would be needed earlier.  Due both to religious and professional obligations, the witness could be available to testify either remotely on the morning of one trial day or available for a trial deposition over the weekend.  Plaintiff opted not to conduct the deposition.  Id. at *6.  Plaintiff got to cross-examine the witness for six minutes longer than defendant’s direct.  Plaintiff had “ample time” (was on notice before the trial started) and an alternative (weekend deposition) to prepare her cross-examination.  Moreover, plaintiff did not argue that she did not cover all of the topics she wanted to cover.  Id. at *7.  Because the trial court gave the parties equal time and plaintiff had opportunities to make sure she conducted a full cross-examination, the trial court did not abuse its discretion.

The final two points raised on appeal have to do with a claim of privilege.  During discovery, defendant claimed work product protection and attorney-client privilege over the results of an internal litigation product study conducted at the request of defendant’s in-house counsel and only shared with outside counsel.  The study results were reviewed in camera by a special master who upheld the claim of privilege.  A ruling that was affirmed by the trial court.  Id. Defendant, however, did produce to plaintiff the underlying test data.   

Plaintiff made three arguments why the study results should have been produced.  First, plaintiff claimed that defendant’s corporate representative waived privilege by mentioning the study during this deposition.  However, the witness’s testimony was that he was not aware of the results of the study, had never seen the results, and did not know its conclusions.  Id. at *8.  He could only testify to the underlying data, which plaintiff already had.  Second, plaintiff argued privilege was waived when defendant gave a study-related document to a consulting expert.  While it was unclear if the document contained the study results, even if it did,

such a disclosure does not necessarily waive the work product privilege [as] . . . a disclosure made in the pursuit of trial preparation and not inconsistent with maintaining secrecy against opponents does not waive the privilege.

Id. at *8 (citation omitted).   Finally, plaintiff claimed that she was entitled to the information because she had a substantial need and an inability to obtain a substantial equivalent.  But plaintiff could not explain her position in light of having the underlying data and the ability to have her own experts conduct their own testing.  Id.  at *10.  Any allegation that the study results were adverse to defendant were pure speculation.    Therefore, the appellate court sustained defendant’s objection to producing the study.

Plaintiff’s last and related point was that she should have been allowed to argue in closing that had the study’s results been favorable to defendant, defendant would not have kept them secret.  Id. However, during trial, plaintiff advised the court that the closing would not contain “an inference about any results or anything else.”  Id. at *11.   Plaintiff kept that promise and concluded her closing without making any inference.  Therefore, plaintiff’s point on appeal directly contradicts her statements to the trial court.  In other words, the trial court did not rule on this issue because the issue was not presented at trial.  The appellate court would “not convict a trial court of error on an issue that not put to the trial court to decide.”  Id.  (citation omitted).

Thanks to Ben Hulse from Norton Rose for sending us this decision and congratulations to him and the rest of the trial team that included DLA Piper, Kuckelman Torline Kirkland, and Jerry W. Blackwell. 

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

Breaking new ground, a court has for the first time held that the Medical Device Amendments to the Food, Drug, and Cosmetic Act expressly preempt product-liability claims implicating a Class II medical device brought to market through the “de novo” classification process. This is an important and long-overdue development.

As readers of the blog are painfully aware, courts have for years cited Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), for the proposition that the only claims expressly preempted by 21 U.S.C. § 360k(a) are those implicating Class III devices that received premarket approval under 21 U.S.C. § 360e, and that conversely claims implicating Class II devices or Class III devices that received 510(k) clearance rather than premarket approval are not preempted. As we have explained here and here, Lohr was outdated when decided and is inconsistent with the current statute. Nevertheless, for decades the overwhelming majority of lower courts have reflexively understood Lohr as conclusively foreclosing preemption in cases involving medical devices without premarket approval (or an investigational device exemption).

Fortunately, some courts have begun to rethink things.

For example, in Kelsey v. Alcon Laboratories, Inc., 2019 WL 1884225 (Utah Dist. Ct. 2019), which we discussed here, the court held that 21 U.S.C. § 360k(a), the MDA’s express-preemption provision, preempted design- and manufacturing-defect claims targeting device that was subject to “special controls” imposed by the FDA through the 510(k) clearance process under 21 U.S.C. § 360c(a)(1)(B).

In the case we report on today, Dickson v. Dexcom, Inc., 2024 WL 3417392 (W.D. La. July 15, 2024), the court held that § 360k(a) preempts claims challenging the safety and effectiveness of a Class II device whose sale was authorized by the FDA through the “de novo classification” process.

Congress first established the de novo classification process—codified at 21 U.S.C. § 360c(f)(2)(A)(iii)—as part of the Food and Drug Administration Modernization Act of 1997, and then amended the process when it enacted the Food and Drug Administration Safety and Innovation Act in 2012. For a device to be classified as a Class II device through the de novo classification process, its manufacturer must submit, among other things, the device’s draft labeling and “valid scientific evidence” demonstrating that any “special controls” imposed by the FDA pursuant to 21 U.S.C. § 360c(a)(1)(B) are adequate to provide a “reasonable assurance” of the device’s “safety and effectiveness.” 21 C.F.R. § 860.220.

Dickson involved an external glucose monitoring device. By regulation, all external glucose monitoring devices are subject to certain special controls. They require, among other things, that the device manufacturer submit “[r]obust clinical data demonstrating the accuracy of the device in the intended use population,” “[c]linical study results” meeting specified “performance requirements,” and proposed labeling that addresses certain enumerated topics. 21 C.F.R. § 862.1355.

As the Dickson court recognized, “the special controls established under 21 C.F.R. § 862.1355 are device-specific label and design requirements.” 2024 WL 3417392, at *5. This is significant because, according to the Supreme Court, 21 U.S.C. § 360k(a) preempts a state-law claim only when federal law has established “device-specific ‘requirements’” applicable to the device in question. Riegel v. Medtronic, Inc., 552 U.S. 312, 322 (2008).

Having determined that the imposition of special controls through the de novo classification process establishes device-specific federal requirements, and therefore satisfies the first prong of Riegel’s preemption test, the Dickson court next considered whether the plaintiff’s claims were based on state-law requirements “different from, or in addition to” those federal requirements and thereby satisfied the second of the Riegel test.

The court had no trouble concluding that the plaintiff’s claims would in fact impose state-law requirements different from or in addition to the special controls imposed through the de novo classification process. As the court noted, the plaintiff did not allege that the “defendant failed to comply with the FDA regulations,” attacking instead “both the safety of the product’s design and the adequacy of its label notwithstanding the FDA’s approval.” 2024 WL 3417392, at *7. Under these circumstances, the plaintiff’s claims would necessarily “impose requirements ‘in addition to’ those made by the FDA” and were therefore expressly preempted by § 360k(a) as construed in Riegel. Id.

That should have been the end of the matter.

Unfortunately, the court then went astray and granted the plaintiff leave to amend her failure-to-warn claim based on a mistaken legal assumption.

The plaintiff argued that her failure-to-warn claim avoided preemption because the device’s label, although indisputably compliant with federal requirements, “could have been changed” to comply with purported state-law requirements “under the FDA’s Changes Being Effected (‘CBE’) regulations to reflect” what she characterized as “newly acquired information on the risk of harm.” Dickson, 2024 WL 3417392, at *7. Assuming “for the sake of argument that there might have been some way for [the manufacturer] to bring … post-approval information to the FDA’s attention that would have triggered a change in its labeling requirements,” the court allowed the plaintiff an opportunity to amend her complaint to adequately allege the existence of such “newly acquired information.” Id. at *8.

There are two major problems with that.

First, as the defendant noted and the plaintiff did not dispute, the medical-device “CBE regulation, 21 C.F.R. § 814.39(d)(2), is only applicable to manufacturers of Class III devices.” 2024 WL 3417392, at *8. Given that limitation, the Dickson defendant could not use the CBE regulation to change its label.

Second, even if contrary to fact § 814.39(d)(2) were applicable to Class II devices, it allows but does not require a manufacturer to provisionally change a device’s label under certain conditions. See 21 C.F.R. § 814.39(d)(1) (labeling change “may be placed in effect”) (emphasis added). But, “[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted” by 21 U.S.C. § 360k(a). McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005); cf. National Meat Ass’n v. Harris, 565 U.S. 452, 460 (2012) (if “a slaughterhouse may take one course of action” under federal law but “must take another” under state law, the state-law requirement is “different or additional” and is expressly preempted) (construing 21 U.S.C. § 678)).

If the plaintiff files an amended complaint, the defendant manufacturer will be allowed to file another motion to dismiss. Hopefully the court will correct its error on the second go. Despite its errant treatment of the medical-device CBE regulation, Dickson is an important decision inasmuch as it holds, Lohr notwithstanding, that claims targeting a Class II device that received de novo classification are subject to express preempted under 21 U.S.C. § 360k(a).

Photo of Steven Boranian

We are celebrating an anniversary today:  We wrote our first blogpost on July 26, 2013.  Eleven years and hundreds of posts later, we have two observations.  First, we seriously need to update our blog profile photo.  Or maybe we will just ride out our blogging years promoting the fiction that we are younger and fitter than we actually are.  Second, the topic of our first blogpost was express federal preemption, because what would the blog be without a discussion of preemption? 

Express preemption did not prevail in that case eleven years ago, but what goes around comes around.  A federal court in Maryland ruled just the other day that the Medical Device Amendments to the FDCA preempted all state-law claims involving a metal-on-metal prosthetic hip replacement.  Moreover, the court’s order is noteworthy because this plaintiff tried most every avenue to get around express preemption, and the court shut down each route one by one. 

The plaintiff in Chiapello v. Corin USA Ltd., No. SAG-23-3149, 2024 U.S. Dist. LEXIS 129332 (D. Md. July 23, 2024), attributed a whole host of physical and mental issues to his FDA-approved metal-on-metal hip replacement, and his lawsuit alleged claims for design defect, failure to warn, and breach of implied warranty.  The problem for this plaintiff, however, was that his hip implant was a Class III medical device that the FDA approved under its rigorous pre-market approval process.  Id. at *2-*3.  We know from the Supreme Court’s landmark opinion in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that PMA devices are subject to express preemption.  The district court explained it as follows, in an eminently quotable passage: 

The FDCA’s statutory scheme contains two preemption provisions relevant to this case.  Congress specified that any action “for the enforcement, or to restrain violations” of the FDCA must be brought “by and in the name of the United States.”  21 U.S.C. § 337(a).  And the MDA provides that no state may impose “any requirement” regarding the safety or effectiveness of a medical device “different from, or in addition to, any [federal] requirement . . . .”  21 U.S.C. § 360k(a).  Together those two statutory provisions preempt “nearly all types of claims concerning FDA-approved medical devices.” 

Id. at *8-*9 (emphasis added) (quoting In re Medtronic, Inc., Sprint Fidelis Leads, 592 F. Supp. 2d 1147, 1161 (D. Minn. 2009)).  We like this quote for a couple of reasons.  First, it echoes the essential statutory language, which prohibits state requirements “different from or in addition to” federal requirements.  Second, the court here is giving full credit to section 337(a), which grants the United States the exclusive power to enforce the FDCA.  Courts do not acknowledge often enough that there is no private right of action, but this court got it.  As we’ve discussed elsewhere, considering section 337(a) as an express preemption provision means that the benighted “presumption against preemption” does not apply.

Federal law therefore expressly preempted the plaintiff’s claims in Chiapello unless the plaintiff could plead a so-called “parallel claim”—a valid state-law claim that is parallel to federal requirements and therefore is not “different from or in addition to” federal requirements.  It is difficult to square the “parallel claim” exception with the lack of any private right to enforce the FDCA.  In addition, because so many federal requirements deal with submissions to the FDA, it is also difficult to square the “parallel claim” exception with Buckman, which holds that claims for “fraud on the FDA” are preempted, too. 

These issues led this district court to apply a two-prong test:

Essentially, then, to state a claim, a plaintiff [must] meet both prongs of a two-prong test: (1) the plaintiff must allege that the manufacturer failed to comply with a specific federal requirement applicable to the device, and (2) the plaintiff must explain how that violation . . . also violate a provision of state law, since the FDCA forbids a plaintiff from advancing a private claim. . . .

Chiapello, at *9-*10.  We like to focus on the second prong—a violation of state law.  Although it seems obvious, courts sometimes give this prong short shrift.  The most notorious example is the Ninth Circuit’s wrongly decided opinion in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013), which held that the plaintiff had stated a “parallel claim” under Arizona law that the defendant failed to warn the FDA about adverse events—a claim that does not exist under Arizona law.  (The Ninth Circuit also applied the “presumption against preemption,” which as mentioned, is now defunct in express preemption cases.  But don’t get Bexis started on that.) 

Having framed the issue this way, the district court in Chiapello rejected all seven of the plaintiff’s attempts to state parallel claims.  First, the plaintiff alleged deficiencies in the defendants’ design process, but that claim was preempted because it imposed additional design requirements more stringent that those imposed by the FDA.  Second, the plaintiff faulted the defendant for failing to conduct “adequate bio-compatibility studies.”  The plaintiff did not, however, cite any specific federal provision requiring bio-compatibility studies, so this too would have imposed additional requirements.  Third, the plaintiff pressed “component discrepancy allegations.”  The court did not understand these allegations, and the plaintiff alleged no facts to support them in any event.  Chiapello, at *14-*15. 

Fourth, parroting Stengel, the plaintiff alleged that the defendant violated FDA reporting requirements.  But, unlike the Ninth Circuit, this court did not fall for it:  “Several of these reporting duties are owed only to the FDA . . . .  To the extent these requirements would establish some duty owed to Plaintiff, Plaintiff has neither identified the duty existing under state law nor alleged any facts to substantiate a violation of any such duty.”  Id. at *15.  Amen.

Fifth, federal law preempted the plaintiff’s claim that the defendant failed to recall or stop marketing the devices because federal requirements permitted marketing.  Sixth, the plaintiff alleged a failure to address “non-conformance” and other quality control issues, but he did not identify a federal statute or regulation requiring such actions.  A state claim would just be adding on.  Seventh, and finally, federal law preempted the plaintiff’s claims for failure to train physicians and failure to warn because the plaintiff did not allege how the training failed to comply with federal requirements, and manufacturers are not permitted to deviate from FDA-approved warnings.  Id. at *16-*17. 

This is the correct outcome on all counts, resulting from a disciplined application of express preemption.  Many thanks to Andrew Kaplan at Crowell & Moring for sending the order our way.  

Photo of Lisa Baird

Decades ago, California had a well-deserved reputation for inventing new varieties of tort liability.  California would hatch an idea to expand liability; law professors would churn out thought-pieces taking the theory in new and further directions; judges across the country would struggle with whether to adopt the concept or constrain it in some fashion; eventually some guardrails would be put into place—and then the cycle would repeat. 

The tort of negligent infliction of emotional distress (or “NIED” as some call it) was one such California tort liability invention.  As Bexis explained in discussing the tort in the product liability context back in 2011, negligent infliction of emotional distress differs from intentional infliction of emotional distress.  Intentional infliction of emotional distress is more firmly established, turning on “outrageous” conduct, the defendant’s knowledge or reckless disregard that emotional distress will result, and the severity of the plaintiff’s emotional distress.  (And of course, it is even more deeply established that plaintiffs can recover for their own emotional distress as one type of recoverable damages, once they have proven up a tort cause of action such as strict products liability or negligence.)

Negligent infliction of emotional distress really is a different thing entirely from both the tort of intentional infliction of emotional distress and ordinary emotional distress damages.  The plaintiff asserting the tort of negligent infliction of emotional distress is not the person who suffered the principal physical injury.  Rather, the negligent infliction of emotional distress plaintiff generally witnesses an injury being inflicting on someone else, but has not experienced any direct physical harm to himself or herself.  The Restatement characterizes negligent infliction of emotional distress as a claim derivative of that asserted by the directly-harmed and physically-injured plaintiff.  Rest.3d Torts, Liability for Physical and Emotional Harm, § 48.

In Dillon v. Legg, 68 Cal.2d 728 (1968), the California Supreme Court willed the claim of negligent infliction of emotional distress into existence in a case where a plaintiff-parent was emotionally traumatized by witnessing a driver collide with her child, even though the plaintiff-parent was a bystander—not only physically uninjured, but entirely outside the “zone of danger” and not at any risk of being hit herself. 

Following the California pattern, after Dillon minted this new claim, courts flailed around trying to define the scope of the tort and develop limiting principles.  Did the negligent infliction of emotional distress plaintiff have to be a relative?  If so, how close a relative?  What if the negligent infliction of emotional distress plaintiff heard the crash, but didn’t see it?  Did the emotional trauma have to manifest into at least some physical symptom, like a heart attack or migraines?  Or are mental health problems, like anxiety or depression, alone enough? And so on.  Put another way, “[d]ecisions following Dillon had, ‘like the pebble cast into the pond,’ expanded the bystander distress claim and ‘created ever widening circles of liability.’”

By the time it got to Thing v. La Chusa, 48 Cal.3d 644 (1989), even the California Supreme Court realized that the tort’s requirements were being too “relaxed on grounds that they . . . created arbitrary limitations on recovery,” and that courts were giving too “[l]ittle consideration . . .  to the importance of avoiding the limitless exposure to liability.”  Id. at 656.  Thus, Thing took a stab at some bright-line rules, including that recovery for negligent infliction of emotional distress would be available only if the plaintiff was present at the scene of the injury-producing event as it occurred, and also was aware that the victim was being injured.

California being California, though, Monday’s opinion in Downey v. City of Riverside, 2024 Cal. LEXIS 3887, 2024 WL 3491142 (Cal. July 22, 2024), brings negligent infliction of emotional distress right back where we started from:  Restarting the cycle by knocking down perceived arbitrary barriers to recovery, and once again moving toward limitless exposure to liability.

Downey, in some ways was a prototypical parent-child-car accident negligent infliction of emotional distress claim:  

Plaintiff “was giving driving directions to her daughter over cell phone when her daughter was severely injured in a car crash.  [Plaintiff] heard the collision and its immediate aftermath, but she could not see what had caused it.”

The Downey court presumed it was fine that the plaintiff had not seen the accident, and instead had only heard the collision “in real time” over the telephone.  The court also wasn’t troubled by the fact that what the plaintiff heard (crash noises, followed by a good Samaritan’s request for silence so he could listen for a pulse) arguably might be less distressing than visually observing traumatic wounds from a violent accident. 

What makes Downey most notable, however, is that the relevant negligent infliction of emotional distress claim was asserted not against the driver of the other car, but against a municipality and a property owner who allegedly had created road conditions that contributed to the accident.

The question Downey addressed thus was whether a negligent infliction of emotional distress claim can be pursued “if the plaintiff is aware that injury has been inflicted on the victim, but not of the defendant’s role in causing the injury.” 

And of course, California concluded that it did not matter that the Downey plaintiff had no “contemporary awareness” of the alleged road hazard, much less the existence of the municipality and property owner’s involvement in the condition of the road at the time of the crash—such defendants still could be sued for negligent infliction of emotional distress, even if their alleged roles came to light much later. 

Whether this is a decision consistent with Thing or sound as a matter of policy we will leave to the chattering classes.

What concerns us here is what this might mean for our area of interest, medical device and pharmaceutical product liability.  This is where Downey’s discussion of medical malpractice and product liability on the one hand, and negligent infliction of emotional distress on the other, comes in.

Traditionally, California has been skeptical of negligent infliction of emotional distress in the medical malpractice context.  For example, Bird v. Saenz, 28 Cal.4th 910 (2002), rejected negligent infliction of emotional distress for children of a surgical patient because they were not in the operating room to witness the physician mistakenly transect their mother’s artery, even though they saw their mother’s resulting physical distress later.  In Golstein v. Superior Court, 223 Cal.App.3d 1415 (1990), parents who watched their son receive a radiation treatment could not recover for negligent infliction of emotional distress because they did not at that time realize the dose would prove fatal.  And in Wright v. City of Los Angeles, 219 Cal.App.3d 318 (1990), watching a paramedic conduct a cursory exam, and fail to detect signs of sickle cell shock, did not support negligent infliction of emotional distress because there was no evidence the relative recognized the patient was being injured by the exam.

Similar concerns about what the plaintiff was, or was not, aware of has limited the utility of negligent infliction of emotional distress claims in product liability cases.  In Fortman v. Förvaltningsbolaget Insulan AB, 212 Cal.App.4th 830 (2013), for example, the claim was rejected even though the plaintiff saw her brother die because the plaintiff’s contemporaneous perception was that her brother was having a heart attack; her realization that the “true cause” of the accident was a product defect resulting in an equipment failure came later, and was not enough.

Negligent infliction of emotional distress was seen to be only “rarely” available in such cases, because medical malpractice and product liability injuries often are unlike “catastrophic events” like an explosion, traffic accident, or electrocution.  When the negligent medical treatment is provided—or when the allegedly defective product is made—those are “injury-causing events” that remain “essentially invisible to the plaintiff” as they occur.

But going forward, will that hold true, now that Downey has held that California does not require negligent infliction of emotional distress plaintiffs “to show contemporaneous perception of the causal link between the defendant’s conduct and the victim’s injuries”? 

Downey itself allowed a negligent infliction of emotional distress claim against defendants allegedly responsible for the road condition in a car crash case, even when the plaintiff had no contemporary awareness of the road condition, much less the defendant’s responsibility for it.  Just as the creation of road conditions is an injury-causing event that was “essentially invisible to the plaintiff as it occurs”, so too is the medical malpractice alleged in Bird or the product defect alleged in Fortman. 

Downey even puts a pin in the issue, noting that “whether the court analyzed” the negligent infliction of emotional distress issue in Fortman “correctly is beyond the scope of issues presented in this case”, and dropping a footnote to distinguish other “product-related injuries where a bystander would immediately perceive the event as injury-causing.”

It is little comfort that the California Supreme Court pays lip service to the recognition that “not all forms of emotional trauma associated with harm to a loved one are compensable” because Downey seems to suggest California has returned to the pre-Thing days of anything goes negligent infliction of emotional distress.  For our clients’ sake, we hope we are wrong about that.

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