Photo of Stephen McConnell

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. 

Photo of Michelle Yeary

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. 

Photo of Andrew Tauber

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.

Photo of Stephen McConnell

Many years ago an especially wise in-house lawyer (he is a reader of the blog, and we know he will understand that this reference comes from respect, not sycophancy) told us that law firms angling for his business usually aimed their pitches incorrectly. Lawyers love to brag about their trial prowess.  That turns out to be not so impressive. There is both a credibility and relevancy problem. Aside from a small number of trial gods and goddesses sprinkled throughout Chicago and a couple of other places (you know who they are), the bragging is mere puffery.  Moreover, a vanishingly small percentage of cases actually go to trial.  Law firms would be smarter to hawk their skills at crafting advantageous settlements.  

We know that the settlement in In re CPAP, 2024 U.S. Dist. LEXIS 126219 (W.D. Pa. July 17, 2024), is well crafted.  How do we know that?  First, the long, long roster of lawyers involved is filled with superb practitioners.  When we see names like Chris Seeger, David Boies, and John Lavelle (as well as many other brilliant attorneys) we know that things were done at a very high level.  Second, this particular settlement withstood a vigorous attack by dissident plaintiffs, and the judge who rejected that attack (Judge Joy Flowers Conti) knows MDL practice as well as anyone. 

What was the nature of the attack on the CPAP settlement?  The dissenting plaintiffs, who had become officious intermeddlers, were MDL plaintiffs who did not have the injuries that the defendant agreed to settle with other plaintiffs. Those dissenters/objectors/interneddlers asked the court to rewrite the master settlement agreement to include their alleged injuries.  They also argued that certain provisions of the settlement agreement, such as the standard language about how the plaintiff lawyers will cease advertising for new cases and will withdraw from representing eligible claimants who do not wish to settle, somehow violated the plaintiff lawyers’ ethical obligations.  The objectors cited ABA Model Rules 1.7 (conflicts of interest) and 5.6 (restriction on practice of law). That last argument seems specious when read against the explicit terms of the settlement agreement, which made clear that the settlement in no way restricted the plaintiff lawyers’ practice of law, and that the plaintiff lawyers would act in the best interest of their clients.  

But there was a more fundamental reason why the judge rejected the objectors’ challenge to the settlement: those objectors lacked standing. This was a private settlement that is not a class action.  The master settlement agreement was not subject to court approval. The Third Circuit has made clear that a “district court is not a party to the settlement, nor may it modify the terms of a voluntary settlement agreement between parties.” 

Private litigants can settle on any terms they find acceptable.  There is no requirement that an MDL settlement embrace all plaintiffs and all claimed injuries.  The objectors in this case were non-settlers. Their claimed injuries were not qualifying injuries under the master settlement agreement. Thus, their rights were not legally affected in any way by the decision of other plaintiffs to settle their claims for other injuries.  The objectors suffered no legal prejudice, and they remain free to pursue their own claims.  

The objectors likewise lacked standing to object to allegedly unethical restrictions on the practice of law by other attorneys that do not, and had never, represented them.  Implicitly, although not discussed, this aspect of the opinion appears to stand for the proposition that MDL lead plaintiffs’ counsel owe no ethical duties to MDL plaintiffs they do not formally represent – though we recognize that not everyone (including not every judge) agrees with that proposition. 

Photo of Michelle Yeary

We’ve been covering the Lone Pine Zostavax saga for a long time.  See Part 1, Part 2, and Part 3.  The story moved to the Third Circuit late last year and now we have its ruling.  The appellate court upheld the district court’s entry of a Lone Pine order and its subsequent dismissal of 1,189 plaintiffs who failed to comply with that order. 

Let’s start with a look back.  The Zostavax MDL, in which the majority of plaintiffs allege they contracted shingles after taking the shingles preventive vaccine, was created in 2018.  That’s pre-Covid, pre-Felicity Huffman college admission scandal, and before we lost Queen Elizabeth II and Ruth Bader Ginsburg.  In the ensuing 4 years, plaintiffs worked up five bellwether cases which were all dismissed for lack of expert evidence establishing case specific causation.  That’s because plaintiffs’ experts could not rule out that plaintiffs contracted shingles due to exposure to chickenpox as children.  Based on unrefuted evidence presented by the defendant, only a PCR test is determinative.  In re: Zostavax Products Liability Litigation, 2024 WL 3423709, *1 (3rd Cir. Jul. 16, 2024). 

Therefore, based on that “compelling medical authority,” the court entered a Lone Pine order in March 2022.  That’s after Will Smith slapped Chris Rock but before Elon Musk bought Twitter.  Plaintiffs were given 90 days to produce PCR test results or their cases would be dismissed.  None did (note PCR tests have to be administered at the time the person is experiencing the rash).  Id. at *2.

So, defendant moved to dismiss those 1,189 plaintiffs and the court granted the motion in December 2022.  Right around the time Britney Griner was freed from a Russian prison but shortly before the US Air Force shot down a Chinese spy balloon off the cost of South Carolina.  Not only had plaintiffs failed to comply with the Lone Pine order, in opposing the dismissal plaintiffs failed to offer any prima facie evidence of specific causation. Id.

Plaintiffs appealed.  The appeal was argued approximately 9 months after the dismissal was entered.  Coincidentally the same 9 months Kevin McCarthy was speaker of the House.   Which brings us to today.  Given the events of the last couple of weeks, we’re not sure what the words are to describe the “now.”  Maybe we’ll come back and edit this post with a little perspective down the road.  For now anyway, we’ll turn to what the Third Circuit had to say. 

On appeal, plaintiffs argued that the district court erred in both entering the Lone Pine order and in dismissing their cases.  On Lone Pine, they argued the court was wrong to “assume” PCR testing is the only way to prove specific causation and wrong to require the production of “non-existent” evidence.  Id.  The district court did not make any “assumptions.”  Plaintiffs knew since the beginning of the litigation that there was an obvious alternative cause for their injuries—latent chickenpox. 

But even after three years of litigation, plaintiffs had not drummed up a single piece of medical literature or expert medical opinion explaining how it can be determined that Zostavax and not chickenpox caused a person to contract shingles other than through PCR testing.

Id. at *3.  Therefore, the Third Circuit concluded that the Lone Pine order was based on “uncontradicted record evidence” that specific causation would require PCR testing.

As to plaintiffs’ “non-existent” evidence argument, the “express goal of a Lone Pine order is to winnow non-compliant cases from an MDL.”  Id. (citation omitted).  Meaning, the orders contemplate that at least some plaintiffs do not have and will not be able to get the requisite expert evidence.  Making Lone Pine orders valuable tools for managing MDLs.  Id.  The fact that no plaintiff would be able to meet this particular evidentiary hurdle, production of a PCR test result, does not make it an improper order.  As repeatedly pointed out by both the district and appellate courts, plaintiffs did not provide any other specific causation evidence or even a viable theory. 

Plaintiffs also made two arguments claiming the district court abused its discretion in dismissing their cases with prejudice.  First, plaintiffs argued they were denied their “rightful opportunity” to work up the cases through to summary judgment.  Id.  But that ignores that defendants filed a Rule 41(b) motion to dismiss and plaintiffs were given a “full and fair opportunity to be heard regarding [their] failure to comply with the court’s order.”  Id.  This was not a situation where plaintiffs were dismissed sua sponte for failing to produce PCR tests results.  Nor can plaintiffs claim they were not on notice.  In the opinion that accompanied the Lone Pine order, the district court warned—either make the court aware of prima facie evidence of specific causation or defendant will be entitled to move for dismissal.  Id. at *4.    So, while the Lone Pine order required PCR testing, plaintiffs did nothing in the allotted 90 days to propose alternatives to the court.  Nor did they offer any alternative in opposition to defendant’s motion to dismiss.  They vaguely claimed their experts could prove specific causation using differential diagnosis techniques, but “they did not identify their experts or explain how they would accomplish these aims.”  Id.  The Third Circuit was left as “puzzled” as the district court as to why plaintiffs would promise they had more but not offer it to defeat dismissal.  It simply goes against “common sense.”  Id.

Plaintiffs second argument was that the district court failed to properly weigh the Poulis factors, referring to Poulis v. State Farm Fire & Cas. Co., 747 F.2d 863, 868 (3d Cir. 1984) (setting forth six factors a trial court must balance before dismissing a complaint):  (1) the extent of the party’s personal responsibility; (2) the prejudice to the adversary; (3) a history of dilatoriness; (4) whether the conduct of the party or the attorney was willful or in bad faith; (5) the effectiveness of alternative sanctions other than dismissal; and (6) the meritoriousness of the claim or defense.  Poulis offers a set of non-mandatory factors aimed at making sure a dismissal is not arbitrary.  Plaintiffs did not act willfully or in bad faith, but they did “insist[] they could prove specific causation  . . . without PCR testing,” while admitting it was required in state court litigation.  In re: Zostavax, at *5.  Further, plaintiffs had done nothing to demonstrate that they could ever succeed on the merits.  Allowing 1,189 non-meritorious cases to sit on the MDL docket would be severely prejudicial to defendant.  Therefore, dismissal was an “effective sanction.”  Id.

Photo of Bexis

We’ve reviewed litigation precedent concerning causation-related genetic testing orders on the Blog twice before, in 2020 and in 2015.  We even proposed a rule of federal procedure to govern the conditions under which such testing could occur, which predictably went nowhere, since there is no crisis – yet.  Here’s another update.

As we discussed before, the ongoing Zostavax MDL has turned largely on plaintiffs’ failure to conduct what would have been conclusive genetic testing – to determine whether their alleged (and highly questionable) injuries were caused by wild zoster (chicken pox) virus, as opposed to the genetically distinct weakened form of that virus used in the defendant’s vaccine.  That failure prompted the first MDL-wide Lone Pine order requiring plaintiffs to produce genetic testing results, if they had them.

There is compelling medical authority that a laboratory test of the shingles rash of a person who has had chickenpox is the only way to tell whether the shingles was caused by the virus strain contained in [the vaccine] or by the wild-virus strain from chickenpox latent in a person’s body.

In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2022 WL 952179, at *2 (E.D. Pa. March 30, 2022), aff’d, 2024 WL 3423709, at *3 (3d Cir. July 16, 2024) (genetic “testing [wa]s the only way to establish specific causation”).  The strong scientific basis for compelling genetic testing justified requiring plaintiffs to produce such testing, if it existed, and dismissing their cases on causation grounds if they failed to offer supportive test results.

[Plaintiffs have] not cited any medical literature or expert medical opinion explaining how it can be determined that [the vaccine] caused a person to contract shingles other than, as defendants have shown, through a testing of that person’s rash. . . .  [Plaintiffs] have not provided any guidance as to how the more than 1,700 . . . cases can proceed in a reasonable manner without a Lone Pine order. . . .  It is now time for plaintiffs to come forward with the Laboratory Reports or other documentation . . . to enable the court to weed out non-meritorious from meritorious claims and move along these 1,700 or more cases toward a final resolution.

Id. at *3.  As we discussed here, not a single MDL plaintiff subject to the order had obtained the necessary testing, and as a result all of those bogus claims were dismissed.  In light of Zostavax, MDL defendants should consider adding genetic testing to plaintiff fact sheets, as was done in the pending Paraquat MDL (Part VIII(E)).

In California, a judicially created requirement that discovery implicating “privacy” interests must be supported by a “compelling” interest to support genetic-related discovery was rejected in Williams v. Superior Court, 398 P.3d 698 (Cal. 2017).  The “compelling need” standard was “an unduly onerous burden” on parties’ rights to discovery.  Id. at 87-88.  Williams expressly overruled Johnson v. Superior Court, 95 Cal. Rptr.2d 864, 878 (Cal. App. 2000), which (as we discussed in 2015) had required genetic testing demands to meet that “compelling” interest requirement.  The “compelling need” standard was “an unduly onerous burden” on parties’ rights to discovery, and thus could apply “[o]nly [to] obvious invasions of interests fundamental to personal autonomy.”  398 P.3d at 88-89 n.8 (listing overruled cases).  Thus, we think that the standard for genetic testing discussed in Cruz v. Superior Court, 17 Cal. Rptr.3d 368, 369 (Cal. App. 2004), remains valid in California.

Litigation-wide genetic testing is also being litigated (no ruling yet) in asbestos litigation in New Jersey:

A motion has been filed by defendant in the matter of Mizer v. Nissan North America seeking a sample of plaintiff’s DNA to test for mesothelioma markers to address pre-disposition to a mesothelioma diagnosis; thus an alternate causation theory. . . .  Subject to a continuing development of medical science, I would like to resolve this once.

Re Genetic Testing for Mesothelioma, Letter setting briefing schedule (N.J. Super. Law Div. dated May 15, 2024).  Developing scientific literature is providing an increasingly solid basis for requiring genetic testing in purported asbestos/mesothelioma cases, as discussed most recently in this scientific article:

Various hypotheses, including exposure to increasing amounts of environmental carcinogens, have been proposed, yet there are no firm data to support these hypotheses.  Mesothelioma, one of the best examples of a cancer caused by environmental carcinogens, is one of the malignancies that we see with increasing frequency in younger patients.  This is very difficult to explain because asbestos causes cancer about 30 to 60+ y[ears] after initial exposure, thus most asbestos workers developed mesothelioma when they are old.  Because, asbestos use was banned in the 80s, former asbestos workers are now in their 70s to 90s, thus we should see mesothelioma in older not younger patients!

F. Novelli, et al., “Germline BARD1 Variants Predispose to Mesothelioma by Impairing DNA Repair & Calcium Signaling,” forthcoming, at p.1, Proc. Nat’l Acad. Sci. (accepted 6/12/24).

Thus, it’s no surprise to see genetic testing orders in asbestos litigation.  Our prior post already discussed Ortwein v Certainteed Corp., 2014 WL 12911977, at *4-6 (Cal. Super. Dec. 22, 2014), and Thrash v. Boeing Co., 2018 WL 2573097, at *3 (N.D. Cal. March 2, 2018).  To those we can now add Sotomayor v. Honeywell International, Inc., 2024 WL 3402783, at *2 slip op. (Cal. Super. March 19, 2024) (genetic testing mandated because “[n]o other feasible alternatives exist to obtain information about whether Plaintiff has the BAP 1 gene mutation”) (“Sotomayor Order”); and McCabe v. 3M Co., No. 1CCV-22-0001318, slip op. (Haw. Cir. Aug. 30, 2023) (ordering genetic testing of mesothelioma patient).

Whole exome genetic testing was ordered in Bruning v. Sanford Clinic North, 2023 WL 9315388 (Minn. Dist. Aug. 17, 2023), a medical malpractice case involving cerebral palsy.  Such testing “has become a standard ‘work-up’ for genetic disorders.”  Id. at *2.

Plaintiffs must prove the cause of [minor plaintiff’s] injuries, and as such, her genetic makeup is really and genuinely in controversy.  The Defendant has established good cause for whole exome sequencing.  Specifically, multiple doctors going back to 2019 have recommended and referred [minor] for genetic testing, based upon her symptomology, her developmental disorder, and her history of seizures. . . .  [R]ecent studies have shown that cerebral palsy is often the result of a genetic condition, not an injury that occurred sometime during labor and delivery. . . .  [T]here are hundreds of possible genetic disorders that may have caused [these] injuries.

Id. at *3 (citations omitted).  See also Simbolon v. North Memorial Health Care, 2010 WL 11889566, at *1 (Minn. Dist. Aug. 18, 2010) (genetic testing ordered in cerebral palsy case where defendants established “good cause to compel a blood sample” through an expert’s opinion and the sampling being “minimally invasive”).

Other recent cases that turn on the results of plaintiff genetic testing include:  Doe v. Netflix, Inc., 2023 WL 2213626, at *2 (S.D. Ind. Feb. 24, 2023) (plaintiffs ordered to sign authorizations for defendant to obtain results of genetic testing they previously underwent at the website 23andMe); First Midwest Bank v. Rush University Medical Center, 2020 WL 4284554, at *3-4 (N.D. Ill. July 27, 2020) (denying plaintiff’s motion to exclude alternative causation testing based on both “the results of genetic testing” and “because the genetic testing is not complete (for instance, mitochondrial gene sequencing was not performed, and [the] was not tested)”); See also Adacsi v. Amin, 2013 Alb. J. No. 988, ¶¶10-12, 14 (Alb. App. 2013) (on the facts, an alternative genetic cause was “not frivolous”; “Since the appellant has chosen to sue for damages, she cannot deprive the respondents from acquiring evidence that may assist in their defence.”) (Canadian decision).

On the other hand, Kallal v. Lyons, 189 N.E.3d 916 (Ill. App 2021), illustrates both a limitation on genetic testing, and as a direct consequence, what we think is a strong merits defense argument against causation.  Over strenuous objection, the trial court in Kallal ordered the parents of the minor plaintiff to undergo genetic testing on the strength of expert testimony that the claimed injuries “likely have a substantial genetic cause.”  Id. at 919.  However, the relevant rule, allowing physical examinations, was limited to “a party,” and the parents, were not themselves parties.  Id. at 920 (a “requirement of the rule was ‘that the physical or mental condition of a party is in controversy’”).  Thus, the genetic testing – no matter how medically justified or crucial to proving causation – was not permitted by the rule.  See also Young v. United States, 311 F.R.D. 117, 121 (D.N.J. 2015) (same result under Fed. R. Civ. P. 35); Meyers v. Intel Corp., 2015 WL 3643470, at *2-3 (Del. Super. June 11, 2015) (same result; genetic testing of minor plaintiff allowed).

Thus, the plaintiffs prevented genetic testing in Kallal and these other cases on something of a technicality − that the relevant rules did apply to non-parties.  Assuming, however, that the defendants were right on the medicine (if not the law), we don’t see how any of these plaintiffs could ultimately establish causation at trial, since their own opposition was what prevented the testing that could have ruled out genetic causes as an alternative reasons for their claimed injuries.  Plaintiffs still have the burden of proving causation, and they cannot advance an admissible differential diagnosis in the presence of a valid but unresolved alternative cause.  E.g. Matuszak v. Cerniak, 805 N.E.2d 681, 686-87 (Ill. App. 2004) (“a differential diagnosis that fails to take serious account of other potential causes . . . cannot provide a reliable basis for an opinion”) (citation and quotation marks omitted).  Without the requisite testing, the genetic cause in Kallal and similar cases cannot be ruled in or out, so these plaintiffs’ very act of preventing genetic testing should eventually preclude them from proving their case at trial. Since the plaintiffs themselves were responsible for the lack of testing in such cases, any contrary argument would seem rather weak.

Thus, in both prescription medical product liability, and other forms of tort litigation, plaintiffs’ resistance to genetic testing discovery leaves them open to adverse causation inferences at trial.  Plaintiffs necessarily have superior access to their own genetic material.  If they manage to avoid medically valid genetic testing on some procedural basis, then in the absence of any testing ruling out a genetic alternative cause supported by the medical literature, they fail to prove their case.

Last week, FDA released for comment a draft guidance titled Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.  FDA guidances are nonbinding recommendations without force of law, and this is only a draft.  Nonetheless, it addresses a frequent and important problem in our industry.

Continue Reading FDA Releases Draft Guidance on Responding to Internet Hogwash
Photo of Eric Alexander

In simpler times for those of us of a certain age, what we learned in elementary school was often supplemented during Saturday mornings watching cartoons.  While you could pick up some information watching Super Friends or Captain Caveman, the catchy songs and minimalist animation of Schoolhouse Rock! really helped to teach children a range of things they could use.  For instance, we learned the magic of the number three and the function of conjunctions.  As the U.S. Bicentennial approached, we were treated to a basic civics lesson in “I’m Just a Bill.”  In telling his tale, Bill described a basic part of the Constitution and separation of powers with a name that is not as well known, the Presentment Clause.  (Not to be confused with the term “presentment” that law students learn in their “Commercial Paper” class and usually forget soon after the final exam.)  The concept is simple:  a bill passed by both houses of Congress is not a law until the President signs it (after it is presented to him/her).  Among the obvious implications of this are that bills cannot become laws without the signature of the President and the President cannot make a law without Congress passing a bill first.  Like virtually every provision of the Constitution, there are Supreme Court decisions on the Presentment Clause, most notably in the post-Schoolhouse Rock! era, Clinton v. New York, 524 U.S. 417 (1998), concerning the Line Item Veto Act.  We had never seen the Presentment Clause raised in a drug or device case, however, at least one that had been august enough to merit a post or mention on these hallowed pages.

That changed with a recent decision of the MDL court in In re Gardasil Prods. Liab. Litig., No. 3:22-MD-03036, 2024 U.S. Dist. LEXIS 113839 (W.D.N.C. June 27, 2024).  We have discussed previously how the court had held most of the claims asserted by the bellwether plaintiffs were preempted.  (A similar decision was reached as to the same vaccine by another federal court before the MDL.)  We have also discussed how having a childhood vaccine MDL is peculiar.  Because it is an MDL trying to promote efficiency, the court invited other pending plaintiffs to move to avoid the application of the preemption ruling to their own substantially similar claims.  This was clearly not an invitation for a global re-do.  Yet a group of plaintiffs, implicitly conceding they had substantially similar claims and no basis to be treated differently than the bellwethers, offered the new argument that the application of the Vaccine Act to the particular vaccine at issue in the MDL violated the Presentment Clause.  Really, the argument applied equally to every vaccine now on the Vaccine Injury Table—we will explain that—that was not there when the National Childhood Vaccine Injury Act of 1986 was signed into law by President Reagan on November 14, 1986.  This is, legally speaking, a ludicrous argument.  Picking just one of the new ones, the seasonal influenza vaccine—i.e., the flu shot—has become part of the rhythm of life for school age children and their parents.  Were these plaintiffs correct, then children with anaphylaxis, shoulder injury related to vaccine administration, vasovagal syncope, and Guillain-Barre Syndrome, within a specified onset period for each, would be ineligible for participation in the Vaccine Injury Compensation Program without proof of causation.  Without speculating too much about the motivations for pursuing this novel argument in the context of a vaccine for human papillomavirus, we can say that a win for plaintiffs on this argument would frustrate the purpose of Congress, be bad for public health, and be good for plaintiff lawyers.  See here and here.  It also seems to fit with the disturbing pattern we have noted previously of litigation against medical products for women’s health, given the data on utilization by sex and the purpose of HPV vaccines.

Luckily, the Gardasil court shouldered aside the argument and stuck to its prior position.  The argument could have been rejected solely based on the procedural posture.

Although the broad constitutional question now raised by Plaintiffs is not the type of argument that the Court intended to invite in allowing other plaintiffs to raise individual issues after the resolution of [the bellwether plaintiffs’] motions, the Court will consider the merits of Plaintiffs’ constitutional challenge so as to put it to rest for all Plaintiffs.

Id. at *27.  The Presentment Clause argument was the procedure for adding covered new vaccines required action by the Secretary of Health and Human Services rather than a bill passed by Congress that was signed by the President.  This sole case support for the argument was a dissent in a 1999 case from the Federal Circuit.

Agreeing with this contention (which no court has ever accepted), would result in the effective removal from the Vaccine Act of all of the childhood vaccines developed in the nearly 40 years since its enactment in 1986, notwithstanding decades of vaccine table additions and the routine enforcement of the Act with respect to those “new” vaccines.

Id. at *30.  There is also more than a decade worth of vaccine preemption decisions since Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011).  While Bruesewitz involved the diphtheria, tetanus and pertussis vaccine, which was part of the original vaccine table, many of the decisions finding preemption since then have involved vaccines added to the table.  Implicit in every decision was that the addition was not invalid due to a constitutional infirmity or otherwise.  That nobody, as far as we know, had even raised the Presentment Clause in connection with litigating preemption based on the Vaccine Act says something.

A claimant under the Vaccine Injury Compensation Program has an easier route if he/she claims a “table injury.”  The Vaccine Act sets out a procedure for adding a new vaccine and specified injuries to the table.  Essentially, when the CDC recommends a new vaccine for routine administration to children, the Secretary of HHS adds it to the table within two years by promulgating a regulation.  Based on a 1993 amendment to the Vaccine Act, the addition takes effect only if/when Congress enacts an excise tax on the vaccine and the President signs the bill.  The test for an exercise of impermissible legislative power by the Executive branch—of which HHS is a part—comes from Field v. Clark, 143 U.S. 649 (1892), and the Vaccine Act’s application to HPV vaccines did not not come close to meeting it.  The addition of vaccines to the original table was based on future events—i.e., the development, approval, and acceptance of new vaccines—and was not discretionary for the Secretary of HHS.  2024 U.S. Dist. LEXIS 113839 at *38.  In addition, because of the requirement of an excise tax before the Secretary’s action has any real effect, Congress retains legislative authority.  That happened with the HPV vaccine expressly in the Tax Relief and Health Care Act of 2006, which was passed by Congress and signed by President G.W. Bush.  “Therefore, the Secretary’s inclusion of ‘Additional vaccines’ in accordance with the specific directions in the statute does not violate the Presentment Clause.”  Id.

That was more than enough.  However, even the dissent that plaintiffs cited had recognized that the process for adding new vaccines to the table through the Secretary’s rulemaking authority was constitutional.  Id. at *39 n.3 (citing Terran ex rel. Terran v Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1321 (Fed. Cir. 1999) (Plager, J., dissenting)).  The Terran dissent took issue with a different provision of the Vaccine Act than the provision that authorized adding vaccines to the table.  Of course, because it was a dissent, the Terran majority had found otherwise:  “[W]e hold that the Vaccine Act does not violate either the Presentment Clause of the Constitution or the nondelegation doctrine that emanates from separation of powers principles.”  195 F.3d at 1317.  The Federal Circuit, of course, takes appeals from the Court of Federal Claims, which is responsible for challenges to a Special Master’s decisions on claims under the Vaccine Injury Compensation Program.  In other words, for the court with jurisdiction specific to the system set up by the Vaccine Act, the binding authority for twenty-five years was that the Vaccine Act did not violate the Presentment Clause.  Making the Gardasil plaintiffs’ argument in the Court of Federal Claims probably would have ventured in Rule 11 territory.  This brings us back to why an MDL on a childhood vaccine should exist at all.  It is a good thing that Bruesewitz’s preemption of design defect claims for covered vaccines is binding authority in the Western District of North Carolina, as in all other federal courts.  After the Presentment Clause detour, the court’s ruling preempting design claims now applies to every plaintiff in the Gardasil MDL, which is clearly correct.

As a bonus, here is the Schoolhouse Rock! episode on separation of powers and here is the episode on the nation’s anti-autocracy roots.  This one shows an injection of a medication, but presumably not a vaccine.

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.
Learn more about this book