Today’s case is a straight warnings case.  So, there should be little surprise that if it involves a generic drug preemption shuts it down.  But that does not mean that plaintiffs did not try several avenues of attack to try to find a warning claim that would stick.  None did.

The case is Roncal v. Aurobindo Pharma USA, Inc., 2022 WL 1237888 (D.N.J. Apr. 27, 2022).  Multiple plaintiffs and their spouses brought suit against the manufacturer of generic amiodarone, a drug used to treat atrial fibrillation.  Id. at *1.  While the decision does not specify where all plaintiffs are from, we know they are not all from New Jersey and appear to hail from various states around the country.  That’s important because the court had to figure out what law to apply to defendant’s motion to dismiss.  The complaint only mentioned New Jersey and federal law, but plaintiffs apparently argued that the law of their respective states of residence should apply.  Id. at *2-3.  What plaintiffs failed to argue is how the law of their home states conflicted with New Jersey law.  Absent evidence of a conflict, “the law of the forum governs.”  Id. at *3.  Further, plaintiffs only identified their states of residence, not the states where their injuries occurred – which is the presumed applicable law for personal injury claims.  Therefore, on the additional ground of failing to provide the facts necessary to make a proper choice of law analysis, the court chose to apply New Jersey law to all plaintiffs’ claims.  Id. at *9n.4.

Having decided to apply New Jersey law, the court’s next decision was whether all of plaintiffs’ claims were subsumed by the New Jersey Products Liability Act (“NJPLA”).  There was no dispute that the two strict liability claims – failure to warn and manufacturing defect – were subsumed.  But plaintiffs also alleged negligence and fraud claims which if arising “from the independent conduct of a defendant, which is unrelated to the inherent defect in the product itself,” may exist outside the NJPLA.  Id. at *4.  Here they did not.  All of plaintiffs’ claims were premised on three warnings-based sets of allegations:  failure to provide a warning in the form of a Medication Guide; the failure to report adverse events; and the deficiency of the warnings themselves.  Id.  Because the negligence and fraud claims were based on the same products liability allegations, they could not stand separate from plaintiffs’ NJPLA claims and therefore were dismissed.  Id.

That leaves the court’s final analysis on those two NJPLA claims.  First, plaintiffs really did not have a manufacturing defect claim.  The allegations in that count only talked about warnings, labeling and the Medication Guide.  Without any allegation about the product being in a “substandard condition,” plaintiffs simply recast their warnings claims into a count titled manufacturing defect.  The court treated it like another warnings claim.  Id. at n.8.

Now we are back where we started – a straight warnings case.  The court looked at each of plaintiffs’ warnings theories separately.  First was failure to provide Medication Guides.  Medication Guides are the FDA-approved warnings that are directed to the patient.  The FDCA requires manufacturers to provide “distributors, packers, and dispensers” either enough Medication Guides to distribute to all prescribed patients or the means by which to generate sufficient Medication Guides.  And the important part of that is “the FDCA requires.”  Therefore, the violation of the FDCA is a “crucial element” of the claim and

Plaintiffs’ attempt to use a state products liability law to seek relief for a violation of this FDCA requirement is preempted under Buckman. 531 U.S. at 353.

Id. at *6.  Preemption is the end of the story, but the court did address plaintiffs’ argument that under New Jersey law plaintiffs had a duty to provide the Medication Guide directly to patients.  Plaintiffs cite to no case or other authority creating such a duty and none exists.  Id. at *7.  Plaintiffs tried to rely on Perez v. Wyeth Labs, Inc., 734 A.2d 1245 (N.J. 1999).  But what that case said was if a manufacturer undertakes direct-to-consumer marketing, there is a corresponding duty to warn the patient.  Roncal, at *7.  Plaintiffs are not alleging direct-to-consumer advertising and therefore Perez is inapplicable.  Here we have to point out the court dropped a nice footnote on Erie conservatism.  Id. at n.12 (diversity courts should be reluctant to create new rights).  Plaintiffs also failed to plead facts sufficient to support their Medication Guide claim and so even if it not preempted it would not have survived.  Id. at *8.

Next plaintiffs argued that defendant failed to report adverse events to the FDA.  First and foremost:

Plaintiffs have failed to identify any state law that requires [defendant] to report adverse events to the FDA, and courts in this District have concluded no such duty exists.

Id.  So, this claim is likewise preempted by Buckman.  Even if not preempted, plaintiffs only support for the claim is that based on the number of prescriptions there appears to be a “dearth of adverse events.”  Id.  Plaintiffs do not point to any adverse event that was not reported.

Then there is the warning label itself.  Plaintiffs argued that by providing the labeling to doctors, via things like the Physician Desk Reference (“PDR”), defendant “failed to correct certain information on which physicians relied.”  Id. *9.  This is Mensing preemption.    A generic manufacturer cannot change the label; it is required to use the same label as the brand. Presumably plaintiffs were trying to argue that the PDR material was not labeling and was a means by which generic manufacturer could have skirted the duty of sameness.  If you have ever seen a PDR, it is quite simply just a collection of the labels.  So, plaintiffs’ argument falls seriously flat.  Once again, the actual pleadings are sorely deficient because not only did plaintiffs not explain how a generic manufacturer would have control over or authority to change PDR materials, they failed to make any allegation about what was misleading in the labeling.  Id.

Finally, while not addressed in the body of the opinion the court dismissed both plaintiffs’ off-label promotion and negligence per se claims as preempted as well.  Off-label promotion claims are preempted because only the government can enforce FDCA which is the sole source of the duties on which such a claim relies.  The negligence per se claim was based either on the same Medication Guide allegations or failure to provide an adequate warning.  One is preempted by Buckman and the other by Mensing.  Id. at n.6.

Many avenues were pursued but they all ended at preemption.

We have promised ourselves that we will stream this week’s “This Is Us” episode when we finish this blog post.  We love this series beyond reason, and we dread its imminent demise, notwithstanding the title’s grammatical transgression.  (We generally condition any sort of allegiance on correct use of predicate nominatives.)  We are struck, over and over again, by writers who “get it,” on so many levels.  For similar reasons, but without the grammar concern, we love today’s case.

Our co-blogger, Mr. Boranian, covered Bond v. Johnson & Johnson, 2021 U.S. Dist. LEXIS 243038 (D.N.J. Dec. 21, 2021), last week, but he concentrated on the choice-of-law issues.  Here, we take a deeper dive into the court’s decisions on the substantive claims.  Bond is a hernia mesh decision out of the District of New Jersey, decided at the very end of last year.   (It was a close contender for our “Ten Best” list, being discussed on today’s webinar.)   It is a decision on two plaintiffs’ motions to dismiss.  Both plaintiffs alleged that they were injured by the defendants’ hernia mesh, and both asserted claims for defective design, failure to warn, and manufacturing defect under the New Jersey Products Liability Act, along with common-law claims for negligence, design defect, failure to warn, manufacturing defect, and breaches of warranties.  The court’s discussion of the plaintiffs’ design defect claims is the source of our delight, and we will save that for last.

As last week’s post explained, the court began with a detailed, more-interesting-than-usual choice-of-law discussion, resulting in applications of the laws of the plaintiffs’ respective places of injury — Michigan and North Carolina — and not the law of New Jersey, where the defendants maintained their principal places of business  and designed their hernia mesh.  Since New Jersey law did not apply, the court dismissed both plaintiffs’ NJPLA claims for defective design, failure to warn, and manufacturing defect, while the North Carolina plaintiff’s remaining claims fell victim to that state’s six-year statute of repose.

The court held that Michigan plaintiff’s manufacturing defect claim failed because the plaintiff had not plausibly alleged that his hernia mesh deviated from the defendants’ manufacturing standards.  His failure-to-warn claim failed under Michigan’s learned intermediary rule, for two reasons.  First, the court held that it was “unable to assess the warning” provided with the mesh “against the omissions [the plaintiff] allege[d],” because the complaint did not set forth the specific language the warnings contained.  Bond, 2021 U.S. Dist. LEXIS 243038 at *33-34.  Second, the plaintiff “failed to adequately allege causation, as he [did not] particularize[] specific omissions or inadequacies supporting his allegations beyond the generally accepted risks of hernia surgery.”  As such, he “failed to plausibly allege that any inadequacies in the warnings proximately caused his injuries.”  Id. at *34-35 (internal punctuation and citations omitted).  Different from the usual “warnings causation” decision, but we’ll take it.  Finally, the court dismissed the express and implied warranty claims because the plaintiff had not provided pre-suit notice “upon discovering a breach,” as Michigan law required.

Now, onto the best part.  We spend our professional life in the mass tort space, defending our medical device clients against “design defect” claims.  This is how it usually goes:  a plaintiff pleads (and eventually his expert offers the “general causation” opinion) that the device is “defective” because it is prone to/capable of something or other, and he pleads that the “defective” device caused his alleged injuries.  But, to satisfy the “causation” element of a design defect claim, a plaintiff is required to plead how a specific defect in his device caused his specific injuries, and mass tort plaintiffs never go beyond generalities and conclusory allegations.  (Nor do typical plaintiffs’ experts draw the requisite causal connections in their eventual case-specific reports.)  Nevertheless, it is nigh impossible to win a motion to dismiss a design defect claim because judges decline to confront the deficiencies of these claims early in the litigation.  The judge in Bond was an exception.

The Michigan plaintiff (remember, the other plaintiff’s claims were time-barred) alleged three “defects” in his mesh:  1) a set of guidelines recommended against the “plug” design of his mesh, as “the incidence of erosion seem[ed] higher” with that design; 2) the “multiple layers” of the mesh resulted in “increased dense adhesion formation” which, in turn, caused a long list of injuries; and 3) the mesh was “susceptible to in vivo degradation,” which caused an overlapping list of injuries.  (Sound familiar to anyone??)

And the court held that the “causation” allegations were not adequate:

[The plaintiff] has failed to sufficiently allege that any of these defects caused his alleged injuries. . . . With respect to the use of a “plug” design,  . . . other than conclusory allegations, [the plaintiff] does not further define “erosion” or explain whether he experienced any of the injuries that [the] design allegedly makes more likely.

Id. at *25 (citations omitted).  Similarly, the plaintiff did not “cite to any study, guidelines, or support for [the] proposition that a “multi-layered” design increased “the intensity and duration of the inflammatory response, thereby increasing dense adhesion formation.”  In other words, he did not explain “how the alleged defect caused his injury.”  Id. at *26-27 (emphasis in original, internal punctuation and citations omitted).  “Further,” the court held, the plaintiff “failed to differentiate his injuries from those that normally attend hernia repair surgery, with or without mesh.”  Id. at *27.  Finally, the plaintiff did not “cite to any materials supporting [the] proposition” that the defendants’ mesh was prone to in vivo oxidative degradation, nor did he “explain the term . . . or provide any further explanation of how such degradation” caused his alleged injuries.  Id. at *29.

The court concluded:

Without further explaining how [the mesh] causes the injuries [he] enumerates and whether he in fact experienced those injuries, [the plaintiff’s] allegations are conclusory and do not suffice.  He has failed to allege a logical sequence of cause and effect explaining why the multi-layered polypropylene mesh design would have caused his particular injuries.

Id. at *30 (internal punctuation and citations – including citation to Iqbal – omitted).   The only fly in this ointment is that the court dismissed the design defect claim without prejudice and with leave for the plaintiff to amend.  But we are immensely heartened by (and will cite) this rare decision emphasizing the “causation” element of a design defect claim and imposing consequences on a plaintiff who did not satisfy his burden to plead this element of the claim.

We will keep our eyes open for motion practice addressed to an amended complaint in this case. In the meantime, stay safe out there.

In general, people do not like to have to repeat themselves.  It is unavoidable.  Sometimes your audience is rightfully (or wrongfully) distracted.  Sometimes you aren’t that clear.  Sometimes you lose your zoom audio connection and have to start over.  Sometimes you don’t notice your daughter’s earbuds are in and that she’s been watching a YouTube video instead of hearing anything you just said.  It happens.  But a judge’s written opinion telling you everything you failed to do to state your case is not the same as trying to be heard across a table in a loud restaurant.  So, we think judges probably fall into the category of people who really, really do not like to have to repeat themselves.  It is a waste of time, effort, and resources.  So, when a court’s decision on a second motion to dismiss starts with “[t]he allegations in the Second Amended Complaint are the same as in the First Amended Complaint” except now plaintiff alleges more devices caused his injuries” – forced repetition follows.  Vicente v. DePuy Synthes Companies, 2021 WL 5150196, *2 (D.N.J. Nov. 5, 2021).

For context, plaintiff was in a motorcycle accident that caused several fractures in his left leg.  The surgical repair of his injuries included the implantation of orthopedic screws and plates.  Plaintiff required multiple subsequent surgeries for various reasons, including for hardware failure.  Id. at *1.  He sued the hardware manufacturer for strict liability design, manufacturing and warning defects and breach of express and implied warranty.  Id. at *2.   We posted about the court’s first dismissal of this case at the end of last year.  Based on a requested extension of time, plaintiff did not file his Second Amended Complaint until August of this year.  Id. at *3.  He had seven months to fix the pleading deficiencies pointed out by the court and instead decided to make the court do the whole thing all over again.

First the court had to re-dismiss plaintiff’s implied warranty claim because it is subsumed by the New Jersey Products Liability Act (“NJPLA”).  All claims for harm caused by a product in New Jersey fall under the NJPLA except for breach of express warranty.  Id. at *4.  Nothing in plaintiff’s allegations changed the court’s thinking.  Plaintiff’s implied warranty claim was based on an allegation defendant impliedly warranted the device was safe but breached that warranty because the device’s design was flawed.  Id. But that was just plaintiff’s attempt to “disguise[e] what would traditionally be considered a products liability claim as an alternative cause of action.”  Id. at *5.  Basing a breach of warranty claim on an alleged design defect is a just a “re-packaged design defect claim.”

Next the court moved onto the express warranty claim which failed the first time for lack of any factual assertions regarding what plaintiff or his doctors allegedly relied upon.  True too for this go round.  Plaintiff’s second amended complaint failed to allege what descriptions or statements were made to plaintiff to form the basis of any bargain, what plaintiff relied on before undergoing surgery with defendant’s devices, and how any particular product failed to conform to defendant’s description.  Id. at *6.

To state a claim for design defect in New Jersey, plaintiff must allege either a feasible safer alternative design or that the product’s risk outweighs its utility.  Id. at *6.  Plaintiff failed to allege either, instead arguing – again — that he should be able to rely on the consumer expectations test.  But that is only available in New Jersey when it is “self-evident” the product is not reasonably safe and fails to perform as a reasonable consumer would expect.  Id. at *7.   Medical devices are complex and a question like how long an orthopedic screw can last in the presence of an unhealed fracture is not something within the general knowledge of the average consumer or lay person.  Id.  Nor is an allegation that the device broke sufficient evidence of a design defect.  “[T]he design standard is not one of perfection, but reasonableness . . . [i]t is not enough to allege that an injury should not have happened.”  Id.

Nor is the mere happening of an accident, such as a device breaking, sufficient to plead a manufacturing defect claim.  Id. at *8.  In its decision on the first motion to dismiss, the court told plaintiff he was missing factual allegations about the supposed manufacturing defects.  Seven months later the same is true.  Plaintiff still did not allege some deviation from the intended design.  Attempting to rely on a malfunction theory, plaintiff argued the severity, type, and timing of his injuries were enough to “suggest” that something went wrong.  Id. at *9.  But because broken devices can occur in the absence of a defect – meaning plaintiff’s injuries could be the result of other causes – he could not proceed on circumstantial evidence.  Id.

Finally, the court re-examined plaintiff’s identically re-pleaded failure to warn allegations which amounted to nothing more than that defendant knew or should have known of the risk of device failure and the need for revision surgery.  And which the court again found conclusory and insufficient to satisfy TwIqbalId.  But that wasn’t the only thing plaintiff failed to remedy.  Plaintiff’s failure to warn claim also failed under the learned intermediary doctrine to which New Jersey recognizes a direct-to-consumer advertising exception.  But plaintiff failed to allege any DTC advertising to get him around the learned intermediary doctrine.  Last, but not least, the NJPLA has a presumption of adequacy for warnings the FDA finds adequate.  Plaintiff failed to plead any facts to counter that presumption.  Id. at *10.

About the only thing new this time around is that the court dismissed plaintiff’s claims with prejudice.  After seven months, “the differences [or lack thereof] between the First and Second Amended complaints do not suggest that the plaintiff is progressing in the direction of an actionable claim.”  Id.

The DDL blog (again) offers a tip of the cyber hat to Terry Henry at Blank Rome for sending the Vicente case to us.

In the movie Thank You for Smoking, lobbyists for the tobacco, alcohol, and firearm industries got together periodically at a DC watering hole to swap stories about the challenges of representing unpopular clients under increasing scrutiny by the federal government.  Hilarity ensued, along with some other stuff we do not remember very well.  Of course, there are many trade associations in DC focused on a variety of industries, some of which are not terribly popular.  We probably would not have counted the cosmetics industry in that camp, except maybe when it comes to concerns about animal testing.  If we did not do what we do, then we might also not have counted a trade association for the cosmetics industry among likely targets for the plaintiffs in an MDL otherwise centered on product liability claims related to certain talcum powder products.  But we know plaintiffs sue a range of entities other than manufacturers, typically when they are looking to increase the chance that the litigation will stick in the court they prefer, find deep pockets, or muddy the waters in ways they find beneficial.  Such claims rarely succeed because their legal footing tends to be shaky.

We have discussed cases through the years about attempts to impose liability on publishers, research entities, certifying bodies, and sales representatives, for instance, to say nothing of entities that innovated a drug or other medical product (but did not sell what the plaintiff claimed produced her injury).  There also have been a handful of cases discussing the liability of trade associations.  When we saw the recent decision from the talcum powder MDL in the District of New Jersey, we thought it made sense to revisit the subject.  In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation, MDL No. 2738, slip op. (D.N.J. June 16, 2021), concerns a summary judgment motion filed by a trade association defendant called Personal Care Products Counsel (“PCPC”).  Plaintiffs asserted common law negligence, fraud, fraudulent concealment, and civil conspiracy (based on fraud) against PCPC, completed discovery, and, after some procedural steps we will skip, faced PCPC’s motion to get rid of all claims.  The first step was deciding choice of law between DC—where PCPC is based—and New Jersey, with PCPC preferring the former and plaintiffs preferring the latter.

As often happens, the choice of law inquiry was not a forgone conclusion and included some substance even though the court found no pertinent conflict between DC and NJ law.  The core allegation against the PCPC was that it knew talcum powder posed a risk of ovarian cancer for a long time, did not tell consumers about its knowledge, and helped the manufacturer defendants hide that risk from consumers.  The allegedly actionable conduct spanned more than three decades and included petitioning federal and state governments and interacting with FDA, which regulated the talcum powder products at issue under the Food, Drug & Cosmetic Act.  Plaintiffs tried to establish a conflict between DC and NJ law by arguing that the (usually pretty good for defendants) NJPLA applied.  However, plaintiffs had not asserted any NJPLA claims against the PCPC.  Nonetheless, the court went ahead and determined that any claims against the PCPC could not fly under the NJPLA, which limited liability to “manufacturers and sellers.”  Despite the statutory language, plaintiffs argued that PCPC still engaged in “marketing within the definition” of the NJPLA.  Id. at 13.  This argument failed because there was “no evidence that PCPC was in any way involved or exercised control over the marketing” of the products at issue. 13-14.  And no trade association had ever been found to be a “seller” under the NJPLA, something previously rejected by the same court for a “research and development company that performed drug safety and surveillance functions for the manufacturer.”  Id. at 14.  The downside of finding that the NJPLA did not apply was that there was no possible finding that the NJPLA had abrogated or subsumed the NJ common law claims.

The broader impact was that the rest of the decision proceeded under NJ and DC law.  It did not, however, get as far as evaluating the Noerr-Pennington Doctrine, which makes sense because it is a defense and a constitutional one at that.  Under NJ and DC law, the asserted common law claims each failed for plaintiffs’ failure to raise a genuine issue as to at least one element.  Negligence was first and the first element in negligence is always duty.  The surveyed cases from NJ, DC, and elsewhere made clear that trade associations only take on duties to consumers “where the trade association is able to exert control over its members and enforce its safety standard and regulations.”  Id. at 22.  From what we know about trade associations, such control is going to be the exception not the rule.  It was here too as plaintiffs argued that “publishing standards for testing,” publishing a handbook with definitions for cosmetic ingredients, and having a website describing the PCPC’s goal as helping consumers make informed decisions.  The factual record on each of these did not support control or the creation of a duty.  While the inquiry was fact-intensive, other trade associations may take comfort in statements like “[t]he issuance of such voluntary guidance cannot create a legal duty of care to the general public” and “‘public statements espousing aspirational goals, statements of generic intent, or statements vowing or acknowledging that [the association] has duty’ do not ‘constitute promised that would create a legal duty based on a voluntary undertaking.’”  Id. at 24 (funky internal quotation in the original).

Next up were fraud and fraudulent concealment, which were considered together.  Both required reliance and plaintiffs had no evidence of that.  No deposition testimony or even affidavit supported that a single plaintiff in the MDL “knew that PCPC existed or otherwise relied on any statement made by PCPC regarding the safety of talc powder products.”  Id. at 28.  Knowing what sort of self-serving statements end up in plaintiff affidavits when there is a low risk of contradiction or penalty, that lack of such evidence is striking.  It was also the “death knell” for the fraud-based claims.  Id.

Conspiracy also fell because it is not an independent claim in NJ or DC.  Instead, it was premised on the unsupported fraud claims.

We do not claim to know the merits of this MDL or the similar litigation proceeding in other courts.  We have most often discussed them in terms of personal jurisdiction.  (See here and here but something different here.)  We do know, however, that trade associations, like researchers, publishers, innovators, etc., generally have no place as defendants in cases where someone is seeking to recover for an injury from a product.  In the vast majority of the cases we have seen, the product liability claims against the manufacturers and/or sellers of the product should be what decides if the plaintiff can recover.  If she cannot, then the law should not expand to create potential liability for entities or individuals that did not manufacturer or sell the product in an attempt to provide the plaintiff with another chance to recover.



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

Shouldn’t you call it a duck?  Apparently not in New Jersey.  Primarily because New Jersey is still governed by one of our Bottom Ten decisions of 2012Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J. 2012).  Today’s ducky decision was handed down by the trial court in the New Jersey state counterpart to the federal MDL concerning textured breast implants.  We covered the MDL’s decision on defendant’s motion to dismiss just a few weeks ago.  In many respects, the New Jersey state court decision is similar – except for the quacky part on failure to warn.  But let’s look at the basics first.

As in federal court, plaintiffs in New Jersey have brought claims alleging that various of defendant’s textured breast implants and tissue expanders caused plaintiffs to develop or be at increased risk of developing a form on non-Hodgkin’s lymphoma.  In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 2021 N.J. Super. Unpub. LEXIS 837, *1 (N.J. Super. Law Div. May 4, 2021).   Most of the medical devices at issue underwent Premarket Approval (“PMA”) by the FDA.  One line was granted an Investigational Device Exemption (“IDE”) which allows the device to be studied in FDA-regulated clinical trials and the tissue expanders received 510k clearance.  Id. at *2-4.  Plaintiffs’ causes of action were for manufacturing defect, design defect, breach of express warranty, consumer fraud, and failure to warn.  Defendant moved to dismiss all claims as preempted.  We will take them in this order.

New Jersey products liability claims are governed by the New Jersey Product Liability Act (NJPLA), which provides a claim for manufacturing defect where a product deviates from specifications or performance standards.  Id. at *31.  Because plaintiffs alleged that defendant failed to comply with specific manufacturing requirements imposed by the FDA as part of the PMA process, the court found the manufacturing claims were not preempted.  Id. at *32-34.  Not a surprising result in state court at the pleadings stage where plaintiffs provided at least some detail about the alleged manufacturing violations.

In dismissing most of the design defect claims, the court noted that “it is well-settled that design defect claims against devices approved through the PMA process are preempted.”  Id. at *37.  Further, “the express preemption clause of the MDA extends to devices being studied under an IDE.”  Id. at *38.  The court was unwilling to find the design defect claims involving the 510k cleared devices preempted, so those survived.  Id.

The court considered express warranty and consumer fraud claims together.  Here, plaintiffs argued that their claims were based on voluntary statements made by the defendant.  In other words, plaintiffs said they were not challenging the content of the FDA-approved, PMA governed labels and package inserts.  Because voluntary statements are not approved or mandated by the FDA, claims regarding them are not preempted.  Id. at *39-42.

That brings us to failure to warn – the part of the decision that put us in a fowl mood. Plaintiffs premised their failure to warn claims on four different theories:  failure to update the label; failure to conduct post-approval studies; failure to report information to the FDA; and failure to warn based on deliberate nondisclosure.  Again, let’s walk this through.

On failure to update the label, plaintiffs argued defendant was required to use the Changes Being Effected (CBE) process to provide additional warning information.  Id. at *27.  The court, however, recognized that the CBE process is permissive, not required.  Therefore, “a state duty mandating the process is different from or in addition to federal requirements.”  Id. So, this claim was preempted.

Plaintiffs’ failure to warn claims based on a failure to conduct post-approval studies were likewise preempted because there was no parallel state law duty.  Without a basis in state tort law, the claim was an unlawful attempt to privately enforce the MDA. Id. at *29-30.

On failure to report to the FDA, the court ruled the claim was preempted because “New Jersey does not recognize a standalone failure-to-report-to-FDA claim.  Id. at *25.  Relying on a portion of Cornett we don’t take issue with, the court stated that in New Jersey “challenges to the adequacy of the information required by the FDA during the PMA process and label approved by the agency are preempted.”  Id. at *15 (citation omitted).

So to recap, plaintiffs cannot attack the adequacy of the FDA-approved warning directly, cannot bring a claim based on a failure to provide information to the FDA as part of the PMA process, cannot argue that defendant was required to use the CBE process, and cannot challenge whether defendant failed to conduct FDA-required clinical trials.  What’s left?  And what is it that makes us quackers about this decision?  Plaintiffs’ failure to warn claim based on “deliberate nondisclosure” to the FDA survived preemption.

Under the NJPLA, there is no failure to warn if the product is accompanied by an adequate warning.  Id. at *16.  Further, the NJPLA provides a rebuttable presumption of adequacy for FDA-approved labels.  Id.  Therefore, in New Jersey, a plaintiff seeking to rebut the presumption “must plead specific factual allegations of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process.  Id. at *16-17 (quoting Cornett).  These are judicially created “exceptions” to the statutory presumption of non-defectiveness created by FDA compliance.  They are not and never have been causes of action in their own right.  Which means that they are not underlying state law claims which can be said to parallel a federally imposed duty.  Even the court’s description of the supposed parallel claim shows that it is indeed not:

Federal law imposes a duty on manufacturers to comply with post-market federal disclosure requirements. New Jersey law parallels those duties by incorporating compliance with federal regulations as a prerequisite to the presumed adequacy of the label.

Id. at *19-20(emphasis added).  Where is the underlying unpreempted warning-based cause of action?  The court has already tossed the failure-to-report claim and repeatedly describes “deliberate nondisclosure” as a “possible basis for rebutting the presumption” – not as a recognized state law duty on which liability is based.

So, what’s the basis for the court’s conclusion that “New Jersey law requires manufacturers to disclose newly acquired information of harmful effects to the FDA.”  Id. at *22.  The whole concept originated in Perez v. Wyeth Laboratories, 734 A.2d 1245, 1259 (NJ 1999) (“absent deliberate concealment or nondisclosure . . .  compliance with FDA standards should be virtually dispositive”).  But Perez predates Buckman’s holding that fraud on the FDA claims are preempted.  And isn’t nondisclosure just another way of saying fraud on the FDA?  Whether it’s Daffy or Donald – a duck is a duck.

The court jumps from talking about reporting evidence as a method to overcome the adequacy presumption to concluding that “[p]laintiffs’ failure to warn claim founded on deliberate nondisclosure of material information from the FDA is not preempted.”  Id. at *26.  Not only have they created a cause of action that does not exist, but that is practically a textbook definition of fraud on the FDA, only avoiding the word “fraud.”  But that’s what “fraud” is, a deliberate failure to disclose material information.  The causation element of a nondisclosure claim is expressly based upon the contention that, but for the nondisclosure, the FDA would have done something other than what it in fact has done.  That has all the attributes of a fraud on the FDA claim, and it’s preempted under Buckman.  No two quacks about it, Cornett got this issue wrong nine years ago and In re Allergan just dredged it all back up.

We refuse to end the year on a bad note, so we’ll talk about a case that’s good – not good enough to make tomorrow’s top-ten list, but good enough to slam the door shut on 2020 with a reasonable amount of cheer.

Vicente v. Johnson & Johnson, 2020 WL 7586907 (D.N.J. Dec. 21, 2020), is a personal injury case about orthopedic screws and plates used by surgeons trying to put the plaintiff back together after a motorcycle accident. The plaintiff underwent multiple procedures, experienced pain, and ultimately discovered that some of the screws and plates had failed. Those hardware failures prompted the plaintiff to file a lawsuit in New Jersey state court against the manufacturers, the hospital, etc. Then the defendants removed to federal court. Then the plaintiff amended the complaint and added some parties. Then the manufacturing defendants moved to dismiss the complaint. The claims at issue were design defect, manufacturing defect, inadequate warning, and breach of express and implied warranties.

The New Jersey Product Liability Act (NJPLA) governed this case. The first issue was whether the implied warranty claim case was subsumed by the NJPLA. It obviously seemed so, since the claim was physical harm from a product. But the plaintiff argued that the warranty claim was not subsumed because the claim attacked, not product defects, but affirmative misrepresentations regarding the safety of the product. The problem for the plaintiff was that his warranty claim said that the product did not conform to the warranties “in that its design was flawed.” To the Vicente court, this was a “classic products liability-type claim,” and the plaintiff was attempting “to repackage a design defect claim as one for breach of implied warranty.” The court saw no point to that (neither do we), and dismissed the implied warranty claim.

Next up was the design defect claim. The plaintiff did not propose a safer alternative design and did not offer a risk-benefit analysis in an effort to demonstrate defect. Instead, the plaintiff staked his design defect claim on the consumer expectations test. The defendants argued that the consumer expectations test was inapplicable here because the device at issue was complex and outside the experience of an ordinary consumer. The Vicente court ended up agreeing with the defendant that the consumer expectations “shortcut” was unavailable. An average consumer “would not know how long surgical screws maintain their structure after nonunion of a fracture.” Absent alternative design or a risk-benefit analysis, the design defect claim had to be dismissed. (The issue of the applicability or inapplicability of the consumer expectations test to a design defect claim also shows up in a Florida case in tomorrow’s Best-of post.)

The problem with the manufacturing defect claim was the usual one; no manufacturing defect was alleged. The plaintiff attempted to avail himself of “the intermediate product defect test.” What is that? Well it cannot be res ipsa loquitur, because the New Jersey Supreme Court held in the prior century that such theory had no place in a strict product liability case. The intermediate product defect test is different, even if only slightly. It permits an inference of defect when the harm “was of a kind that ordinarily occurs as a result of a product defect” and “was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution.” The Vicente court called this another “shortcut” just like the plaintiff’s reliance on consumer expectations, and just as invalid. The plaintiff simply had not alleged either prong of the intermediate product defect test. In reality, all that the plaintiff was saying was that “the product had a manufacturing defect because it deviated from Defendant’s safety claims.” That might be some kind of claim (more on that later) but it is certainly not a manufacturing defect claim. Or, to borrow the Vicente court’s elegant language, the plaintiff’s contentions “fall short, or perhaps somewhat to the side, of the intermediate product test.”

The failure to warn claim was clothed in hopelessly general and vague language: “The aforesaid product surgically implanted in plaintiff’s body was due to inadequate warning because the defendants knew or should have known there existed a serious risk that the device could fail after surgery, hereby giving rise to pain and suffering, debilitation, and the need for further surgeries.” The court held that such a “blanket assertion” did not “pass the plausibility test.” Nor did the complaint plead anything to rebut New Jersey’s statutory presumption that a warning approved by the FDA is adequate. (This case involved 510(k) products, so the application of the NJPLA presumption of adequacy is noteworthy.)

Finally, the express warranty claim flunked because the complaint contained “ no allegation identifying the language or source of any alleged express warranty.” In other words, the express warranty claim was makeweight. It was a waste of space and time.

2020 was not a good year for wasting space and time.

The DDL blog offers a tip of the cyber hat to Terry Henry at Blank Rome for sending the Vicente case to us.


The tail-end of the year is decorated with all sorts of top-ten lists. Except for Bexis’s magnificent, joyous, life-affirming list of top ten DDL cases, these lists ring hollow against the vast cacophony of this wretched year. But there were some entertainments that temporarily distracted us from COVID-19’s predations and deprivations.

Let’s face it: we were looking to escape plaguey reality. A couple of documentaries allowed us to immerse ourselves in other, better times. The Last Dance brought us back to Michael Jordan’s remarkable reign atop the sports world. It might be a good long while before we see another team win six NBA championships. But the single most transcendent moment of the series was when Jordan paused to recognize the emotional cost of his single-minded determination. And then he got emotional. And then he called for a break. And because it was Jordan, the filming did, indeed, stop.

Back in the late 1970s, we leaned toward the ‘disco sucks’ camp. (Though we did go to a Trammps concert in 1977.) We saw, but did not love, Saturday Night Fever. We heard The Bee Gees (they were utterly unavoidable back then) but had little use for the drum loops and falsettos. It is possible we were wrong. The Bee Gees documentary on HBO, How Can You Mend a Broken Heart, shows how supremely gifted they were. They had several non-disco hits before Saturday Night Fever, such as New York Mining Disaster 1941, Massachusetts, and Lonely Days. Listen here to the harmony of The Bee Gees on Fanny (Be Tender with My Love). Bliss. Then there are the various backstories. Music entrepreneur Robert Stigwood was an important factor in the band’s enormous success, and we once worked for a law firm that represented him. What a fascinating career! (We mean Stigwood’s, not ours.) The Bee Gees’ music sounds much better to our ears after all these years. It seems innocent and uplifting. At the end of the documentary, we get a poignant, unforgettable reflection by Barry Gibb, the lone surviving brother, that he would give up all the hits to have Maurice, Robin, and Andy back. That heartfelt sorrow truly registers in this year of loss.

The Crown has been splendid all along, but the most recent season at last covers ground that is familiar to us. We don’t remember Churchill, but we do remember Thatcher. We don’t remember Princess Margaret’s travails with Lord Snowdon, but we do remember the fractured fairy tale that was the Charles and Diana story. We hear that the Royals hated this season of The Crown. It is not hard to see why. There have even been lists of the moments in the show that most make you want to punch the Prince in the face. (All that being said, did you see the Queen’s Christmas speech? How is it that she manages to convey such dignity and compassion, whilst our elected politicians deliver inane divisiveness?)

The Good Place managed, in its final season, to be both funny and profound. We were already fans. But the deal was sealed for us when a character came up with an ethical solution to the afterlife by consulting the work of our college thesis adviser, the late Judith Shklar. In her masterful book, Ordinary Vices, Shklar argued that we should put cruelty first among all vices. First as in worst. That is, surprisingly, a modern conception. Our ancestors thought vices such as pride and sloth were worse, because they were offenses against God. Cruelty hurts only other humans. But now we know that “only” was misplaced. Be kind, people.

(The only show that supplied us with more laughs than The Good Place was What We Do in the Shadows. Vampires in Staten Island ends up being a strangely plausible premise. But if we list WWDITS, that would add up to eleven. That would be cheating. So we won’t do that.)

There was one podcast that entertained us mightily. In Dead Eyes, the comedian-actor Connor Ratliff is obsessed with his firing almost 20 years ago from the Band of Brothers miniseries. Ratliff thought he got the part, but then Executive Producer Tom Hanks – the nicest guy in Hollywood (or second nicest, after Henry Winkler) – forced Ratliff to reaudition because of his “dead eyes.” The reaudition did not go well. Ratliff has gone on to a successful entertainment career, but this podcast might be the best thing he has done, and one of the best podcasts that anyone has done. Many interesting guests show up on this podcast, including Jon Hamm, Aimee Mann, Seth Rogen, and the guy who ended up getting the part denied to Ratliff.

We’ll add to the pile of praise for Small Axes, which is already sky-high. If you have not already fired up Amazon Prime and watched Steve McQueen’s five films about the West Indian experience in London, fix that right now. This achievement is as good as you’ve heard. Lover’s Rock (which opened up this year’s New York Film Festival) brings us into a house party that feels both strange and familiar, distant and intimate. Mangrove’s second half is a riveting courtroom drama, in which the clients outperform their lawyers.

The Mandalorian. The last scene of the season 2 finale was everything we could have hoped for from the Star Wars universe. Dear readers, we admit we wept.

Some things actually improved as a result of Covid-19 and the requisite social distancing. Think of the NFL Draft, where we got to see the draftees at home with their families, reveling in the major life change about to visit them. Or remember the glimpses we got of coaches in their homes. Cardinals coach Cliff Klingsbury’s modernist residence in Arizona inspired a huge outpouring of house envy. And we were treated to the sight of a dog lounging on a kitchen chair in Bill Belichick’s Nantucket home. Just as the pandemic was shifting into overdrive, the NFL Draft gave us round after round of feel-good moments. They were needed.

We are not choosing political sides (at least not here, not now, and not in your face) by praising the Democratic Convention. What we are actually praising is the roll call of states. That exercise is usually an endless, corny parade of politicos strutting to a microphone in a convention hall of funny-hat wearing, self-important mediocrities bellowing their state’s sketchy virtues. But this year, there was no convention hall. There was, instead, a wonderful pageant of America, as we got views of people and locales scattered around this beautiful country. An Alabama state representative announced her state’s delegation count as she stood in front of the Edmund Pettus bridge, where the late John Lewis survived a brutal police beating. Pennsylvania Senator Bob Casey stood in front of Joe Biden’s Scranton birthplace. Puerto Rico’s delegate spoke in Spanish and reminded the country that Puerto Ricans are American citizens. And did anyone in this last, rotten political season make an argument nearly as compelling as Rhode Island did for its delicious calamari?

We have been watching Jeopardy since the 1960s, when Art Fleming hosted. Alex Trebek took over in 1984, and we stuck with him. We have been told that around 6:55 pm every weekday we start to resemble the Rainman and his anxiety about seeing the daily episode of The People’s Court. Only we don’t bleat about Judge Wapner; we need our daily dose of Jeopardy. It’s been a constant. To be sure, the answer-in-the-form-of-a-question rule is silly, but what other show made showing off knowledge so much fun? We’ve never had the courage to try out for the show, but we have several friends who have, and who have done well. This last season was especially poignant, with contestants thanking Alex for what he meant to them (one champion, Burt Thakur, teared up and told Alex “Here’s a true story, man. I learned English because of you.”) and honoring Alex’s brave, and ultimately unwinnable, battle with pancreatic cancer. In a year filled with loss, Jeopardy showed humanity attaining some kind of grace in the face of such loss.

We hope that you managed to scratch out as much happiness as possible from 2020. We hope that you won’t have to scratch nearly as hard in 2021. Happy New Year.

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


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

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

Let’s dive in.

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

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

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

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

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

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

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

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

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

t’s cold in New Jersey now.  At the time this post hits the blog, it will be about 20 degrees, real feel 15 degrees in most of New Jersey.  That’s too cold for this blogger.  That’s an extra-large cup of coffee for the ride to work.  That’s two-layers of clothing to walk the dog.  That’s dry skin, chapped lips, runny nose, stinging eyes kind of cold.  It can also be sit by a fire with a good book or curl up with a blanket and one of those Oscar-nominated movies you haven’t gotten around to watching yet type of weather.  Or, if you are one of those people who actually like winter, let’s just say we’ll agree to disagree and leave it at that.

But it doesn’t have to be cold outside to get left out in the cold.  That’s what happened to plaintiff in Gomez v. Bayer Corp., 2020 N.J. Super. Unpub. LEXIS 92 (N.J. Super. App. Div. Jan. 14, 2020).  And deservedly so.  Plaintiff’s claims either did not exist under New Jersey law or were preempted.  Plaintiff underwent implantation of a pre-market approved (PMA) permanent birth control device manufactured by defendant.  Plaintiff suffered serious side effects after implantation that ultimately led to her having a hysterectomy.  Id. at *9.  Plaintiff’s complaint alleged causes of action against the manufacturer of the device for:  negligence, breach of express and implied warranties, gross negligence, strict liability, failure to warn, fraud and misrepresentation, and violation of the New Jersey Consumer Fraud Act (NJCFA).  Id.  And that was plaintiff’s first mistake.  With the exception of breach of express warranty, New Jersey recognizes only one products liability cause of action.   All products liability claims are subsumed under the New Jersey Products Liability Act (NJPLA).  So, the appellate court upheld the dismissal of plaintiff’s negligence, implied warranty, gross negligence, fraud and misrepresentation, and violation of the NJCFA claims simply because they don’t exist in New Jersey.  The court did carve out of this section of the decision plaintiff’s negligent training claim, but it didn’t get a warmer reception under the preemption analysis.

The Gomez opinion contains a very thorough discussion of the regulatory framework that serves as the basis for PMA preemption.  Id. at *2-7.  We think you probably all know it, but to summarize – because of the MDA’s express preemption provision and that the PMA process establishes product-specific regulations and requirements, a common law product liability claim is preempted where it would impose a requirement that is different from or in addition to those imposed by the FDA.  When applied to plaintiff’s remaining claims, none made the cut.

The court started with plaintiff’s failure to warn claim – the sum total of which was an allegation that the product “failed to contain adequate warnings or instructions.”  Id. at *24.   Because a device’s labeling and instructions are part of its pre-market approval, any finding that they were inadequate or deficient would be different from FDA’s requirements and therefore must be preempted.  In New Jersey, there is another rub.  The NJPLA provides:

If the warning or instruction given in connection with a . . . device . . . has been approved . . . by the [FDA] under the [FDCA,] a rebuttable presumption shall arise that the warning or instruction is adequate.

N.J.S.A. 2A:58C-4.  Courts have held that this rebuttable presumption of adequacy creates stricter pleading requirements for failure to warn claims.  Gomez, at *18.  To state a claim, the “plaintiff must plead specific facts alleging deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process.”  Id. (citation omitted).  As noted above, plaintiff’s single, unsupported assertion that defendant’s warnings were inadequate fall far below this heightened standard.  Id. at *24.

Plaintiff’s express warranty claim suffered from a similar problem.  When the claim is based on information in the FDA approved labeling, it too is preempted.  Id. at *24-25.  Therefore, under New Jersey law the only breach of express warranty claim that would survive PMA preemption is one based on voluntary statements by defendant that were not approved by the FDA.  Id. at *25-26.  Because plaintiff’s complaint didn’t contain such allegations, this claim was also dismissed.

The court moved on to the negligent training claim.  Here, plaintiff’s allegations were again sparse and very generalized that defendant failed to properly train and screen healthcare providers.  Id. at *28-29.   From this the court could not determine whether plaintiff was alleging a preempted claim.  Plaintiff’s allegations did not include whether defendant departed from any FDA requirement or how.  Moreover, plaintiff failed to allege how the negligent training, whatever it was, caused plaintiff’s injury.  Id. at *29.  This claim failed both on preemption and causation.

Finally, the court read plaintiff’s strict liability claim as a manufacturing defect claim – which also was insufficiently pleaded.  PMA devices have manufacturing regulations with which manufacturers are required to comply.  Plaintiff failed to allege which FDA manufacturing requirements defendant violated, let alone how defendant violated them.  Id. at *31.  Once again. Plaintiff also failed to allege how any purported violation caused her injury.  Id. at *32.

At oral argument, plaintiff admitted to having no additional facts she could plead to support her allegations.  That coupled with New Jersey’s heightened pleading standards for PMA-device claims led the appellate court to affirm dismissal of all claims with prejudice.  There may be only 58 days until spring, but plaintiffs bringing PMA device claims in New Jersey are looking at an extended wintery forecast.

A couple of weeks ago we compared New Jersey litigation with New Jersey food and decided we liked the food better. No aspersions were intended. After all, we grew up in New Jersey and still worship at the altars of Seton Hall Prep, Bruce Springsteen, and the New York football Giants. Anyway, we might need to revisit that comparison. New Jersey product liability law is pretty good. It might not be as tasty as a DeLorenzo’s tomato pie, but it is clear and logical. Gazing across the Delaware River from our current perch in Philly, we are green (definitely not Eagle green) with envy.

A recent decision, Hindermyer v. B. Braun Med., 2019 U.S. Dist. LEXIS 189193 (D.N.J. Oct. 30, 2019), stokes that envy. The plaintiff in Hindermyer alleged existing and threatened injuries from an implanted IVC filter. An IVC filter is a medical device that traps and filters blood clots that develop in the lower extremities. The goal is to prevent such blood clots from reaching the lungs. Originally, IVC filters were implanted permanently. But manufacturers later offered another type of IVC filter that was retrievable and intended for removal after the risk of a thrombotic event subsides. The IVC filter implanted in the plaintiff was of the permanent variety. Over the years, the FDA issued alerts regarding potential complications from IVC filters possibly migrating or causing perforations. Those alerts urged doctors to remove the filters after the risk of pulmonary embolisms subsided. The plaintiff in Hindermyer alleged that despite those alerts, the defendants manufactured and promoted their IVC filters for long term use. Eight years after the IVC filter was implanted, she went into he hospital for pain that was possibly caused by the IVC filter. The IVC filter was still located where it had been implanted. There was no migration. The plaintiff’s doctors did not counsel removal of the filter. The filter had not caused any of the feared serious complications, such as fracture, etc. Nevertheless, the plaintiff alleged that the filter put her at greater risk of those complications. In the complaint, the plaintiff asserted the following ten causes of action against the defendants: (1) negligence; (2-4) design, manufacturing, and warning defect claims pursuant to the New Jersey Products Liability Act, N.J.S.A. 2A:58C-1 et seq. (“NJPLA”); (5) breach of the express warranty; (6-7) breaches of the implied warranty of fitness and implied warranty of merchantability; (8) fraudulent misrepresentation; (9) fraudulent concealment; and (10) negligent misrepresentation. The defendants moved to dismiss the complaint, arguing that all the claims were subsumed by the NJPLA and did not meet that statute’s standards.

The threshold issue was whether the NJPLA did, indeed, govern all the claims in the case. The Hindermyer court explained that the legislative intent behind the NJPLA was “to limit the expansion of product liability law” and to “limit the liability of manufacturers so as to balance[] the interests of the public and the individual with a view towards economic reality.” [We have heard plaintiff lawyers argue that the NJPLA is aberrational. They have even had the chutzpah to argue that position to a New Jersey MDL court as a reason to steer clear of New Jersey bellwether trials! Apparently the concepts of balance and economic reality are aberrational.] In Hindermyer, it was clear that the NJPLA controlled. However the claims were styled, whether as implied warranty, fraud, or whatever, the plaintiff was alleging physical injuries from a product. The case looked like a product liability duck and quacked like a product liability duck. The claims sought product liability damages, so it was subsumed by the NJPLA.

The NJPLA contemplates the usual trio of product liability theories: design defect, manufacturing defect, and failure to warn. The plaintiff in Hindermyer did not allege what needed to be alleged to sustain any of those theories. First, the plaintiff failed to plead a feasible alternative design – that is, “the availability of a technologically feasible and practical alternative design that would have reduced or prevented the plaintiff’s harm without substantially impairing the reasonably anticipated or intended function of the product.” Her notion seemed to be that the permanent IVC filter implanted in her should have been retrievable. But retrievable and permanent are not alternative designs; rather, they are alternative products. The plaintiff did not allege that the temporary version was capable of being made when her IVC filter was implanted. Moreover, her filter was marketed and sold as a permanent filter, whereas retrievable filters are designed to be removed. In the court’s view, permanent and retrievable filters are “inadequate comparators.” Because are entirely different products, the court dismissed the design defect claim.

The plaintiff in Hindermyer fared no better with her manufacturing defect cause of action. Such a claim must plead a deviation from the intended design of the product. The plaintiff did not manage to do that. She had “not identified, within even in general terms, a particular error or mishap in the manufacturing process that caused her Vena Tech filter to deviate from Defendants’ own standards, nor does she contend that her device failed to conform to other identical units.” The gravamen of the plaintiff’s complaint was that her IVC filter did, in fact, conform to the fundamental design of the product as being a permanent implant. Accordingly, the court concluded that the manufacturing defect claim was “inconsistent with [the plaintiff’s] theory of the case,” and dismissed it.

Finally, the Hindermyer court held that the plaintiff lacked standing to sue over a failure to warn of risks that she did not suffer. The plaintiff had not alleged that the defendants “had a duty to warn about chronic right side pain – her only alleged symptom.” Merely being at risk of other complications is not enough. The same reasoning requires dismissal of the plaintiff’s express warranty claim.

So there it is: a fully praiseworthy New Jersey product liability opinion. (Sure, the court refers to the FDA substantial equivalence process as 501(k) instead of 510(k), putting us in mind of Levi’s jeans as opposed to an unfairly maligned FDA regulatory regime, but we assume that error will be corrected before too long – certainly before the next Eagles-Giants tilt.)

Today’s post is an update to our post from just a few weeks ago regarding McWilliams v. Novartis AG, No. 2:17-CV-14302 (S.D. Fla.). At that time, the court denied summary judgment on plaintiff’s failure to warn claims, but applying New Jersey law dismissed plaintiff’s claim for punitive damages. Since the case involves an FDA-approved prescription drug, having found that New Jersey law applied to the punitive damages claim, the decision to dismiss seems very straightforward to us because according to the New Jersey Products Liability Act (“NJPLA”):

Punitive damages shall not be awarded if a drug or device or food or food additive which caused the claimant’s harm was subject to premarket approval or licensure by the federal Food and Drug Administration.

N.J. Stat. Ann. § 2A:58C-5. But plaintiff didn’t think that was where the story should end, so she filed a motion for reconsideration. Look before you leap. Be careful what you ask for. You don’t always get what you want. Whatever adage you want to use, the bottom line is still no punitive damages.

Plaintiff’s argument was solely focused on the exception to the NJPLA’s ban on punitive damages for prescription drugs. That exception says that the prohibition on punitive damages does not apply “where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was material and relevant to the harm in question.” N.J. Stat. Ann. § 2A:58C-5. In its decision last month, the court held that plaintiff had not argued that the exception applies and so the court did not have to address it. McWilliams v. Novartis AG, 2018 U.S. Dist. LEXIS 113862, *22 n.3 (S.D. Fla. Jul. 9, 2018).

In her motion for reconsideration, plaintiff pointed to a footnote in her opposition to the motion for summary judgment in which she did argue that she had adduced evidence of information withheld from or misrepresented to the FDA that made whether the exception applied a triable issue of fact. McWilliams v. Novartis AG, 2018 WL 3637083, *2 (Jul. 31, 2018). That footnote also stated plaintiff’s belief that “punitive damages under New Jersey law are not preempted.” Id. (citations omitted).

The court agreed that it had not considered plaintiff’s argument regarding the punitive damages exception and so granted plaintiff’s request to consider it. Id. And upon considering it, promptly concluded that it was indeed preempted.

If we’re talking about a misrepresentation to the FDA, we’re talking about fraud-on-the-FDA, so we’re talking about Buckman. It feels like a direct line to us. An express even. No stops, twists, turns, or curves. The exception to the punitive damages ban in the NJPLA is a fraud-on-the-FDA claim and Buckman says those are not allowed.  The federal circuit courts that have considered the issue (in the context of similar provisions of Michigan and Texas law) are split with the Fifth and Sixth Circuits finding the exception preempted and the Second Circuit not. Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) and Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012) with Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008). We discuss the split in more detail here, and we’re guessing we don’t need to tell you on which side of the issue we come down.

Fortunately the court in this case was persuaded that the punitive damages exception is “substantially the same” as fraud-on-the-FDA and therefore preempted by Buckman – noting that that was in fact the position of the majority of courts to have considered the issue. McWilliams, 2018 WL 3637083, *3. Another notch on the Garcia/Lofton side of the divide.