When we were small – ten or so – our father worked twenty miles from our home, in the town in which we now live.   The town was – and is – a few miles from the Devon Horse Show, a world-famous affair held for eleven days each spring spanning Memorial Day Weekend.  For one wondrous day of the show, back in those days, we were allowed to skip school.  Our father would drop us off at the show grounds on his way to work – maybe 8 a.m. – and would pick us up around 6 p.m.  We watched everything from tiny children in lead-line classes to Olympic equestrians in jumper stakes.  We never got enough – of the Devon fudge and iconic Devon tea sandwiches, of the overdressed matrons in box seats handed down across generations, and, especially, of the horses.  Oh, the horses.  Sometimes, words alone are enough.  We need only hear the words “Devon Horse Show” to be transported back to our wide-eyed childhood wonder and to chafe with anticipation of the next Devon outing.  Which, we delightedly add, is this weekend.

In the Rule 702-bound world of expert opinions, words are never enough.  To wit, an expert’s opinion carries no weight unless the expert arrived at the opinion through a reliable methodology.  Which, as you will see, the plaintiff’s expert in today’s case did not.  In Johnson v. Depuy Syntheses Prods., Inc., et al., 2022 U.S. Dist. LEXIS 89996 (W.D.N.C. May 19, 2022), the plaintiff suffered severe injuries, including a femur fracture, in a head-on collision between her motorcycle and a car.   The femur fracture was repaired with the defendant’s stainless steel compression plate.  Nine weeks after surgery, x-rays revealed that the broken femur was not healing – was not forming the “callus” a healing bone produces.  About five weeks later, the plaintiff rolled over in bed and felt a “pop” in her leg.  In surgery, the plaintiff’s doctor observed that the compression plate had fractured, and that there was “minimal to no callus at the fracture site.”  Johnson, 2022 U.S. Dist. LEXIS 89996 at *9,

The plaintiff filed suit in state court in North Carolina, and the defendant removed the case to the Western District of North Carolina.  North Carolina law does not recognize strict liability for defective products, so the plaintiff sued for breach of the implied warranty of merchantability.  This cause of action requires a plaintiff to prove that product was unfit for its ordinary purpose, which in turn requires proof that the plaintiff’s injury was due to “the defective nature of the goods.”  Id. at *10 (citation omitted).

Both sides agreed that “high-cycle reverse-bending fatigue” caused the plate to break.  Id. at *8.  The defendants contended that the fatigue resulted from the disunion of the unhealed femur bone, which put undue stress on the plate.  The plaintiff’s expert offered the contrary opinion that “irregular microstructure” of the steel plate, resulting from a manufacturing defect, “most likely contributed to the premature failure” of the plate. The defendant moved to exclude the expert’s opinion, arguing that the opinion was unreliable.  And the court agreed.  The court explained that, while the expert offered the opinion that the plate’s microstructural irregularities constituted a manufacturing defect, he failed “to explain how the plate’s alleged microstructural inconsistency ha[d] any relevance to the question of whether the device was unfit for its ordinary purposes.”  Id. at *10-11.  Specifically, he failed “to articulate any standard of microstructural consistency to which internal fixation devices must adhere in order to sustain the forces placed upon them during ordinary use.  Relying on Sardis v. Overhead Door Co., 10 F.4th 268, 289 (4th Cir. 2021), about which we blogged here, the court held that the opinion was inadmissible ipse dixit because the expert could not “articulate the testing standard to which . . . the defendant was required to adhere.”  Id. at *11.   The court elaborated,

[The expert] does not address what stresses such a plate would have to endure; the length of time the plate’s integrity would have to be maintained until expected bone union; or whether the weight or other physical characteristics of the patient would affect the expected stresses. Moreover, he did not address the degree to which any microstructural inconsistency in the plate would cause it to fail under such expected stress, while a more consistent structure would not.

Id. at *11. The court concluded:

Without evidence of such a standard, a jury would not be able to ascertain whether the plate’s alleged microstructural inconsistency bears any relationship to whether the device was unfit for its ordinary purposes and thus was defective. . . . [The expert’s] conclusory opinion that the irregularity in the plate constituted a manufacturing defect is irrelevant and unreliable, and must be excluded.

And there was more.  The court went on to comment that, even if the expert’s “manufacturing defect” opinion were admissible, he had not presented “any admissible evidence that this defect was a proximate cause of the plate’s failure and thus of the Plaintiff’s injury.” Although the expert offered the opinion that the supposed defect “likely contributed” to the development of the fatigue cracks in the femur plate, he did not “actually opine that this irregularity contributed to the ultimate failure of the plate.”  Id. at *12-13 (emphasis in original).  In other words, the expert did “not state any causation opinion to a reasonable degree of scientific certainty.”   Id. at *13.

There also was no indication that the expert conducted any testing in formulating his opinion. Even the expert conceded that “additional destructive analysis [was] necessary to determine the extent [to which the alleged] manufacturing defect contributed to the failure.” Without such testing, as the court emphasized, the expert’s opinion was “merely a hypothesis – not scientific knowledge within the meaning of Rule 702.”  Id. at *13-14 (citations omitted).   

Finally, the court pointed out that the “hypothetical nature of [the expert’s] causation opinion was further evidenced by his failure to rule out (or even consider) potential alternative causes for the plate fracturing” – a “fatal omission.”  Id. at *15.  And so the court excluded the expert’s opinion, leaving the plaintiff without admissible evidence of a “defect” in the plate.  Without such evidence, the plaintiff could not satisfy this element of her “breach of implied warranty claim,” and the defendant was entitled to summary judgment as a matter of North Carolina law.

We like this opinion.   Seems like an easy answer to us, but we have been on the wrong side of courts getting it wrong on similar facts.  We wish all of you a safe Memorial Day weekend. 

Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”  In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions.  In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support fraudulent misrepresentation claims and other claims based on alleged fraud or mistake.  The lenient courts tend to say things like “without discovery, plaintiffs cannot know enough to plead with particularity” and “the inferences go to the plaintiff at this stage.”  Later, though, when the defendants have spent time and money on discovery and teed up a summary judgment motion, do courts require that plaintiffs have adduced evidence establishing the specific “who, what, when, and where” of any alleged misrepresentation?  In our experience, not often enough.  Instead, some courts let this combination of vague evidence suffice at the summary judgment phase:  1) the prescriber generally saw and considered what sales representatives said about a medical product, 2) no sales representative ever disclosed the existence of some alleged risk that the manufacturer never thought was reasonably associated with the use of the product, and 3) the prescriber would have considered evidence about this alleged risk if some sales representative had provided it to her.  We do not think this evidence should be enough to establish the prima facie case for any claim, but it certainly does not establish particular circumstances for any misrepresentation, whether affirmative or by omission.

The BHR MDL has gotten a lot wrong, particular on preemption, but we think it got this issue right, at least for one case.  By way of brief recap, decisions from the In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litig., MDL No. 2775, have graced our bottom ten list twice in the last four years. (Here and here.) This MDL concerns a PMA device, so parallel claims only fly if state law provides for them in the first place, they are consistent with FDCA requirements, and they are not inconsistent with Buckman.  The BHR court botched that analysis more than once (here and here), including in connection with rulings on expert opinions.  When it has come to summary judgment, however, the results have improved (like here, here, and here), although that may have had more to do with the overall weakness of the claims being asserted.  When the court denied a plaintiff motion for a new trial after a defense verdict, we found the reasoning a bit shaky and the leeway plaintiff had received along the way excessive.

Here, though, we give credit where it is due.  The BHR court dug in to an extent many MDL court do not in granting summary judgment in In re BHR (Hand v. Smith & Nephew), No. 1:17-cv-2775, 2022 WL 1556099 (D. Md. May 17, 2022).  In Hand, the court tackled a range of issues, but the part that stands out to us is the treatment of the misrepresentation-based claims, even with the court’s unwieldy preemption rulings in the way.  The basic facts of Hand are that the plaintiff had a BHR system implanted in her left hip following pain there for close to three years that progressed to her being “significantly disabled,” four prior surgeries in her right hip, and extensive consultation on the risks, benefits, and alternatives.  The BHR surgery maintained more of her femur compared to a total hip replacement.  After attending a patient education class, seeking a second opinion, being warned that she was at increased risk for revision as a woman, and being warned of a risk of metal ions accumulating in her blood, she went forward with the BHR implant in her left hip on June 25, 2007.  About six years later, she reported new pain in her right hip and was diagnosed with increased metal ions in her blood.  About three and a half years after that, she complained of new pain in her left hip, was worked up, and had a left hip revision surgery in December 2016.  She sued a month later, asserting a range of claims, some of which were knocked out by MDL-wide rulings.

After more than five years on the docket, the defendant had its motion for summary judgment heard.  The first issue, somewhat ironically, was whether the plaintiff’s express warranty claim was time-barred.  We will not dwell on this too long as it related to a quirk of Illinois law, which provides a four year statute running from the delivery of the good or service at issue unless there is an explicit promise of future performance.  Here, plaintiff tried to turn a statement in a patient guide about a study reporting “survivorship [i.e., no re-operation] of 98.4 percent at the five-year mark, which is comparable with the survivorship of a traditional total hip replacement in the under-60 age group” into such a promise.  Id. at *5.  The court disagreed, citing the guide’s immediately prior statement that “[i]t is impossible to say how long your implant will last because so many factors play into the lifespan of an implant.”  Id.  Her negligence claims, however, were not barred by the two-year statute of limitations even though she had the following three and half years before she sued:  right hip pain, a related diagnosis of increased metal ions, and a documented concern about revision of her left hip BHR based on the warnings she had received before implant.  “But knowing that her metal ion levels were attributable to her implant is not the same as knowing her metal ion levels were caused by another’s negligent conduct, as Illinois law required to start the clock on her lawsuit.”  Id. at *6.  Were we dwelling on preliminary matters, we might question that reasoning.

Moving on to the meat, though, we see the impact of the preemption and summary judgment rulings addressed in our prior posts on this MDL:  “These alleged misrepresentations must be inconsistent with the FDA label at the time of Hand’s surgery (and this not shielded by the court’s earlier preemption rulings), and they must be false or misleading by omission.”  Id. at *7 (citing the case discussed here).  They also had to have been made between the May 2006 PMA approval and the June 2007 implant, and been relied upon by the implanting surgeon or the plaintiff.  (We think only statements to the learned intermediary, the implanting surgeon, and the surgeon’s reliance should count, but we can set that aside for now.)  Plaintiff offered four communications that were allegedly misrepresentations by omission of information about an increased revision risk in women.  As we said, we do appreciate the court’s dive into the details of the alleged misrepresentations and whether plaintiff’s evidence connected the dots, but there was a basic fact that should have knocked them all out even without preemption:  the implanting surgeon warned plaintiff of an increased revision risk in women before she consented to and had the BHR implant.  The surgeon clearly did not rely on any representation to conclude there was no such increased risk or that it was not worth mentioning.

The first communication up was the patient guide, which allegedly misled plaintiff and the implanting physician.  (In addition to thinking the focus should be solely on the physician, we think alleged misrepresentations in an FDA-approved medication guide would run smack into preemption except in special circumstances.)  The language quoted above from the SOL analysis was alleged to misrepresent the revision risk, particularly because it did not break out the risk by each possible subgroup.  But it was consistent with the rate in the approved IFU at the time and plaintiff had no evidence that she or her doctor relied on the undifferentiated rate.  Id. at *8-9.  As noted, the doctor knew about a higher risk in women, he told plaintiff about it, and plaintiff relied on what he told her in deciding to receive a BHR implant.  Plaintiff offered back-up arguments that the patient guide did not identify a design feature that allegedly caused increased revisions, did not warn about the risk of metal ions, and minimized the complexity and trauma of revising a BHR implant compared to a total hip replacement.  These were all dead ends.  For the design issues, there was no evidence supporting a connection to revision rates until about eight years after the implant and plaintiff did not rely on this part of the guide.  Id. at *9.  For the metal ion claim, the guide’s information on this risk was consistent with the IFU and evidence at the time, and plaintiff relied on her doctor, who warned her about this.  Id. at *10.  The language comparing the revision of a BHR versus a revision of a total hip replacement was again consistent with the IFU, and plaintiff did not rely on this section of the guide.  Id.  We do not need to get way down in the weeds to convey the benefit of the court doing so when it evaluated evidence offered in support of a fraudulent misrepresentation claim.

The evaluation of the other three communications was similar.  Plaintiff claimed the implanter was misled during a November 2006 BHR training course he attended in England.  “But the record does not include information about the content of that training session beyond Hand’s assertions that it was the same as all other Smith & Nephew BHR training sessions.”  Id.  Her expert did not opine on the session and the implanter testified that he relied mostly on published studies, among a range of information.  Many courts might have credited this vague evidence, but this court held that “Hand has failed to generate a record with enough information about the November 2006 training to support a genuine dispute over alleged misrepresentations by Smith & Nephew.”  Id. at 11.  The requirement in Fed. R. Civ. P. 56(c)(1)(A) that plaintiffs in this posture support their positions by “citing to particular parts of materials in the record” is supposed to operate like this.

Plaintiff also claimed there might have been some misrepresentation to the implanter from the sales representatives who delivered the BHR components to him in connection with two prior implants in women.  Again, plaintiff offered general evidence about sales representatives and physician expectations, but “the record contains no information about those two possible sales representative conversations predating Hand’s implantation, and Hand’s argument about misrepresentations during those encounters is entirely speculative.”  Id.  Plaintiff’s last alleged misrepresentation was a June 2007 email inviting the implanter to consult on a possible next generation BHR, “although the design has excellent results.”  Again, there was no evidence to suggest the email deceived the implanter about anything and certainly not about the increased risk of revision in women that “he already knew existed.”  Id. at *12.  So, all of plaintiff’s alleged misrepresentations failed.

She also offered three negligence claims, each of which was decided in the context of the somewhat wacky prior preemption rulings.  On negligent failure to warn, claims relating to warning the plaintiff and implanter were preempted, but plaintiff had a chance to prove a claim based on failing to notify FDA of study data or MDRs between approval and the implant date.  However, the study data plaintiff identified were public, and the implanter did not review the MAUDE database.  “Together, these observations undermine the theory that Smith & Nephew’s alleged failure to warn the FDA about the Australian Registry’s annual reports was either the legal cause or the cause in fact of the Hand’s injuries.”  Id. at *13.  No proximate cause.

Next up was a “negligence per se” claim, which the court generously construed as a claim for common law negligence based on Illinois law according a favorable presumption where there has been a violation of a statute “designed to protect human life or property.”  Given the court’s prior rulings, the plaintiff could not rely on violations of the FDCA—we agree with that—so she offered up three state statutes:  express warranty, manufacturing defect, and “strict product liability.”  Id. at *14.  We see more direct responses to this legerdemain—that Illinois does not have negligence per se, and the statutory presumption cannot be based on law creating civil tort claims—but the court took each in turn.  The work was brief, though, because plaintiff had already lost her claims based on each of those three statutes, one earlier in this ruling and the other two in a ruling on motion to dismiss back on 2018.

Plaintiff’s last gasp was a so-called negligent failure to train claim.  The court had previously found this to be preempted unless it was premised on a failure to comply with the federal requirements.  That exception should not exist because Illinois does not impose an independent duty to train surgeons on the use of a prescription medical device and because Buckman preempts claims premised on violation of a purely federal requirement, but plaintiff had no evidence of any deviation anyway.  So, plaintiff lost that claim too, allowing for the derivative claims for punitive damages and loss of consortium to be dismissed.  Much like the overall path of the BHR MDL, better rulings on global issues would have made for a cleaner decision.  However, when the plaintiffs have failed to muster the evidence they need and the court drills down on what really has to be proven to support misrepresentation and warnings claims, the result ends up the same.

It is hardly a compliment to describe something as “plain vanilla.”  It refers to the simplest version of something, sans any extras.  It is ordinary.  It is not special.  It is dull.  And yet vanilla can be a remarkable, complex flavor.   Our favorite morning Starbucks cold double shot comes with vanilla.   If we get a milk shake, it will be vanilla. We still slip into Proustian nostalgia when we recall a bite of lobster in Madagascar vanilla sauce many years ago at the old Lucas Carton restaurant in Paris.  

While some of the best vanilla does, indeed, come from Madagascar, it turns out that vanilla, like chocolate, traces back to Mexico.  Any civilization that can come up with chocolate, vanilla, mole sauce, the very best version of Coca Cola, Pacifico, and tequila must have exquisite taste.  Vanilla can also come from Tahiti.  Make vanilla ice cream with an egg custard base, and now you have French Vanilla.   Regular vanilla ice cream made without eggs is called Philadelphia style.   These are all just names, we suppose.  Whatever the name, vanilla can taste sublime.  (That being said, the etymology of the word vanilla is surprisingly sexual.)  Vanilla still outranks chocolate in ice cream flavor popularity in the U.S.  So why the lack of respect?

According to Wikipedia, vanilla flavored ice cream “became widely and cheaply available with the development of artificial vanillin flavor.” And that gets us to today’s case, Wach v. Prairie Farms Dairy, Inc., 2022 U.S. Dist. LEXIS 90233 (N.D. Ill. May 19, 2022), which is an interesting food decision and apparently only the latest of several vanilla class actions. FDA law is also implicated, thereby supplying us with an excuse to write about ice cream in a drug and device law blog.   

Vanilla flavor can come from a variety of sources, not just vanilla bean extracts.  In the Wach case, the plaintiffs filed a class action alleging that consumers were defrauded when they purchased an ice cream labeled as “Premium Vanilla” with “Natural Flavors.”  The plaintiffs’ theory was that such terms imply flavor derived from vanilla beans, not something else.   According to the complaint, the vanilla flavor in the ice cream in question pretty much entirely came from something else.  The complaint contained causes of action for consumer fraud (per statutes in Illinois, Wisconsin, and some other states), breach of express and implied warranties, violation of the Magnuson Moss Warranty Act, negligent misrepresentation, common law fraud, and unjust enrichment.  The defendant filed a motion to dismiss.  Because the court held that, even accepting the factual allegations of the complaint as true, the terms “Premium” and “natural flavors” were not deceptive, it dismissed the  complaint.

The essence of the case was that consumer expectations would be dashed upon discovering that the “Premium” vanilla ice cream sourced its vanilla flavor from something other than vanilla beans   The Wach court disagreed.  First, the label nowhere promised that vanilla beans drove the flavor of the ice cream. Indeed, the words “vanilla bean” were absent from the package. Second, “[i]ce cream is routinely identified by its flavor, not by its ingredients.”  Unless you have a remarkable palate, you won’t be able to tell the difference between vanilla ice cream made with vanilla beans versus made with something else.  People who care about ice cream usually care about flavor.  You can purchase bubble gum flavored ice cream (but why would you?). Nobody who does so expects such ice cream to be made from real bubble gum.  (It would be rock hard.) Also, Chunky Monkey, as far as we know, contains no monkey bits.  If ice cream consumers actually care about ingredients, they can read that part of the label.  

The plaintiffs claimed that the “Natural flavors” designation was a lie, but had not alleged sufficient facts to make that claim plausible.  It turns out that vanilla flavoring can be achieved via small amounts of other natural flavors, such as nutmeg.  The plaintiffs alleged that the ice cream contained “atypically elevated levels” of guaiacol, a petrochemical precursor.  That sounds bad. But guaiacol can come from artificial or natural sources.  The complaint offered no “factual basis to suggest that the guaiacol detected in the Product was artificially derived.”

Finally, the plaintiffs demanded that the defendant adopt the approach of some other ice cream brands and market its vanilla ice cream as “artificially flavored”.  In support of this demand, the plaintiffs cited FDA regulations that arguably suggest an acknowledgement of artificial flavors in the label   But plaintiffs were seeking private FDCA enforcement, which plaintiffs cannot do.  To the extent the plaintiffs were suggesting that consumers would be aware of the FDA regulations and would thereby be misled by the ice cream label, the complaint was bereft of any factual allegations supporting such a (wildly improbable) suggestion.  

As we mentioned earlier, this case is one of several vanilla ice cream consumer fraud cases.  The Wach court made note of those precedents, and pointed out that vanilla litigation has left in its “wake a trail of dismissals.”  With the Wach case, that trail of dismissals has gotten even longer.  The plaintiff lawyers must be feeling something akin to an ice cream headache.

New Jersey ain’t Florida and vice versa.  Obviously, it’s warmer in Florida for more of the year and it never gets cold enough to snow.  That could be a pro or a con.  Florida has the second longest coastline among U.S. States which gives it a greater opportunity to have more highly rated beaches.  But a true New Jerseyan will put Cape May and Long Beach Island toe-to-toe with Miami and Destin.  If you’re a football fan, Florida boasts three pro teams (and Tom Brady) while New Jersey technically has none.  That is unless you count the two teams who play their home games in East Rutherford.  But given their recent records (both went 4-13 last year), New York can keep them.  Pro-Florida:  Disney World, oranges, taxes.  Pro-New Jersey:  boardwalks, tomatoes, and not having to pump your own gas.  New Jersey has to live down “The Jersey Shore;” Florida has to live down “Florida Man …” 

In both New Jersey and Florida, there is a strong presumption against punitive damages in drug and device cases where there’s been regulatory compliance. See Fla Stat. §768.1256; N.J. Stat. §2A:58C-4.  But Florida goes a step further with a “one-award” punitive damages statute.  So, while Springsteen will always give New Jersey the overall advantage in a head-to-head comparison, on punitive damages Florida has the edge.

In Benestad v. Johnson & Johnson, 2022 U.S. Dist. LEXIS 55502 (S.D. Fla. Mar. 28, 2022), Defendants filed two motions for partial summary judgement and a motion to bar plaintiff’s punitive damages claim following remand from the MDL pending in West Virginia.  Plaintiff was a resident of Florida at the time she filed her lawsuit.  Her first surgery involving defendants’ pelvic mesh also took place in Florida, as well as her follow-up treatment.  Plaintiff had a second pelvic surgery in New Jersey involving a different one of defendants’ products.  Defendants were also located in New Jersey.  Id. at *17.   In all three of their motions, Defendants argued Florida law applied.  Plaintiff took no position on choice of law in response to either summary judgment motion but argued for New Jersey law in response to the punitive damages motion.  Id. at *15.  Applying the “most significant relationship” test – utilized by both states – which places particular emphasis on the location of the injury, the court concluded that Florida’s relationship predominated.  Id. at *15-17. 

Before turning to the punitive damages claim, we must note the significant paring down of plaintiff’s substantive claims.  Plaintiff’s MDL complaint alleged 18 causes of action.  In response to the summary judgment motions, plaintiff abandoned 11 of those claims including various strict liability, fraud/misrepresentation, and warranty claims.  Of the remaining claims 7 claims, one was for “discovery rule and tolling” which is not a substantive claim; one was for gross negligence which is a “standard of culpability, not an independent claim; and one was for loss of consortium which survived because it was derivative of plaintiff’s design defect claim which defendants did not move for summary judgement on.  Id. at *23, 27-28.  That left three claims – negligent failure to warn, strict liability failure to warn, and punitive damages. 

On the failure to warn claims, Florida’s learned intermediary doctrine requires plaintiff to prove causation by showing “that her treating physician would not have used the product had adequate warnings been provided.”  Id. at *21.  Both of plaintiff’s implanting surgeons testified that they did not read the warnings that accompanied the devices, but both were fully aware of the risks of the surgery, including those experienced by plaintiff.  Id. at *10-13.  So, the evidence demonstrated that their treatment decisions would not have changed.  The only evidence plaintiff offered to support her claim was a notice by the FDA that came out three years after plaintiff’s surgeries – making it immaterial.  Id. at *22. 

Now for the more interesting punitive damages discussion.  Having essentially acquiesced to the application of Florida law to her substantive claims, plaintiff does a bit of an about-face to argue New Jersey law should apply on punitive damages.  As noted above, New Jersey’s punitive damages law for prescription drugs/devices is not exactly plaintiff-friendly.  In fact, New Jersey based companies (like defendants here) often argue for application of New Jersey’s punitive damages law in products cases.  The statute provides:

In any product liability action the manufacturer or seller shall not be liable for harm caused by a failure to warn if the product contains an adequate warning or instruction. . . If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration . . .  a rebuttable presumption shall arise that the warning or instruction is adequate. 

N.J. Stat. §2A:58C-4.

Florida has a similar statute:

In a product liability action brought against a manufacturer or seller for harm allegedly caused by a product, there is a rebuttable presumption that the product is not defective or unreasonably dangerous and the manufacturer or seller is not liable if, at the time the specific unit of the product was sold or delivered to the initial purchaser or user, the aspect of the product that allegedly caused the harm:

(a) Complied with federal or state codes, statutes, rules, regulations, or standards relevant to the event causing the death or injury;

(b) The codes, statutes, rules, regulations, or standards are designed to prevent the type of harm that allegedly occurred; and

(c) Compliance with the codes, statutes, rules, regulations, or standards is required as a condition for selling or distributing the product.

Fla Stat. §768.1256.

So, assuming defendants’ warnings complied with the FDA, plaintiff had a difficult road to punitive damages under either state’s law.  But this case is part of a mass tort, so Florida has an additional statute that gave defendants an extra layer of protection:

Except as provided in paragraph (b), punitive damages may not be awarded against a defendant in a civil action if that defendant establishes, before trial, that punitive damages have previously been awarded against that defendant in any state or federal court in any action alleging harm from the same act or single course of conduct for which the claimant seeks compensatory damages. For purpose of civil action, the term “the same act or single course of conduct” includes acts resulting in the same manufacturing defects, acts resulting in the same defects in design, or failure to warn of the same hazards, with respect to similar units of a product.

Fla. Stat. § 768.73(2)(a). 

Defendants submitted evidence of prior punitive damages awards in cases involving the same products and allegations as in Benestad.  Plaintiff did not offer any evidence in rebuttal, but rather tried to rely on a narrow exception to the rule.  The basis for the statute is that under Florida law, the purpose of punitive damages is to punish the defendant and deter similar conduct, not to further compensate the plaintiff.  Benestad, at *24.  So, the ban on multiple awards may not apply

if the court determines by clear and convincing evidence that the amount of prior punitive damages awarded was insufficient to punish that defendant’s behavior…  In addition, the court may consider whether the defendant’s act or course of conduct has ceased.

Fla. Stat. § 768.73(2)(b).

Plaintiff presented no clear and convincing evidence that the earlier awards were an insufficient deterrent.  Plus, defendants voluntarily took the product off the market ten years ago.  Id. at *26-27.   Therefore, the court found that punitive damages could not be awarded under Florida law. 

You’ll never get this Jersey girl to pick Sunshine over the Garden (except for Key West) – but we can get behind Florida products liability law when it leads to outcomes like this.

Not too long ago we blogged about the value that the Product Liability Advisory Council (“PLAC”) brings to the table – particularly to drug and device manufacturers faced with relentless product liability claims.  For the third time, we urged our corporate readers to support PLAC’s pro-defense advocacy by joining and becoming members.

Still not convinced?  Then check this out.  Next week, PLAC members and invited guests (which can be you) have an opportunity to learn more about PLAC’s amicus work in particular.  On Thursday, May 26 at 3:00 p.m. (Eastern), the PLAC Amicus Case Selection Committee – including Bexis − will host a Town Hall Forum to discuss PLAC’s 2021 Amicus Program and also our view of current trends and developments on issues important to PLAC members.  It’s an opportunity to ask any question you want to the folks who make PLAC’s amicus program work.  So come, take a closer look at PLAC’s advocacy and efforts to influence product liability-related jurisprudence in state and federal appellate courts.

Corporate counsel from drug and device companies are invited to register using this link.  It’s all free, but for obvious reasons pre-registration is necessary.

Hope to see some of you there.

We were talking the other day with a colleague with whom we have been in the mass tort trenches for most of the last 20 years, and she observed that “it’s not about the tort anymore.”  Well, it is, and it isn’t.  We still see cases, sometimes in very large numbers, involving drugs and medical devices where the plaintiffs allege traditional product liability theories, such as negligence and strict product liability.  For those cases, it is still very much about the tort.

What our colleague meant is that plaintiffs now more than ever are pushing other theories of liability, including public nuisance and consumer protection claims alleging economic injuries.  And they often push too far.  Take for example Kimca v. Sprout Foods, Inc., No. 21-12977, 2022 WL 1213488 (D.N.J. Apr. 25, 2002), where the plaintiffs filed a class action alleging the presence of heavy metals in baby food.  Id. at *1.  Based on these allegations, the plaintiffs sought remedies for violations of consumer protection laws of various states, among other claims.  Id. at *2. 

Allegations of heavy metals in Mixed Berry Oatmeal and Crispy Brown Rice Toddler Fruit Snacks certainly grab your attention, but could plaintiffs back those allegations up?  Not really.  In fact, the plaintiffs did not even allege that they (or their children) suffered any harm, which meant that they had no standing to sue.

We have seen this before.  We blogged a few years ago on a Third Circuit case where the plaintiffs tested the boundaries of Article III standing by filing a complaint that affirmatively disavowed any alleged injury.  They lost, with the Third Circuit holding that there are generally three ways to plead an economic injury.  A plaintiff can allege an “alternate product theory” by alleging that, but for the defendant’s conduct, he or she would have purchased an alternative, less expensive product.  A plaintiff can also allege a “premium price theory,” under which he or she claims that wrongful advertising of a product as “superior” induced the plaintiff to pay an unfair premium.  Finally, a plaintiff can allege that he or she was deprived of the “benefit of the bargain” and did not get what he or she paid for.  See In re Johnson & Johnson Talcum Powder Prods. Mktg. Sales Prac. & Liab. Litig., 903 F.3d 278 (3d Cir 2018). 

The plaintiffs in In re J&J Talc could meet none of these standards, and neither could the baby food-purchasing plaintiffs in Kimca v. Sprout Foods.  They surely did not allege that any baby suffered any physical harm.  It was all about purported economic injury, but they failed on that score, too.  They did not allege that they would have purchased an alternate product, let alone one that was less expensive.  Kimca, 2022 WL 1213488, at *8.  They also did not adequately allege that misrepresentations caused them to pay an unfair premium for the product.  Id.  “Threadbare” allegations that they would not have paid as much for the product “if they had known” did not suffice.  The plaintiffs did not identify any comparable, cheaper, or purportedly safer product to demonstrate that they, in fact, paid a premium.  Id.

Finally, the plaintiffs did not allege any loss of a benefit of the bargain because they did not adequately allege that their children were at risk of harm from baby food.  In other words, they got what they paid for.  Id. at *9.  Importantly, allegations of a risk of future harm did not establish an economic injury that conferred standing to sue:

Plaintiffs . . . allege that the Baby Food Products were worthless.  But Plaintiffs assert the products were worthless precisely because they allegedly exposed their children to the risk of future harm—they do not otherwise allege that the Baby Food Products did not perform their intended purpose or that the products were worthless for any other reason.

Id. 

The upshot is that an economic injury claims requires actual harm, and an alleged risk of future harm does not suffice to establish economic injury.  As the court emphasized, the plaintiffs alleged that (1) the products contained heavy metals and (2) elevated levels of heavy metals can be dangerous, but they did not connect the two.  Id. at *8.  They did not allege that the alleged levels of heavy metals in the products were unsafe.  Id.  “Without this connection, Plaintiffs’ allegations are simply speculation.”  Id. 

The district court dismissed the claims for lack of standing, but without prejudice.  Plaintiffs might try again, but it very well could be that they did not allege harmful levels of heavy metals because they could not truthfully do so.  The district court took judicial notice of the FDA’s letter of March 5, 2021, stating that its testing showed no immediate health risk to children from toxic elements in food.”  There may be no “there” there?  Stay tuned.    

This is a follow-up post on the case of Knapp v. Zoetis, Inc. – an animal drug case.  While not our typically fare, it is still a prescription drug case involving adverse event reporting to the FDA and the learned intermediary doctrine.  So, while this patient had four legs instead of two, the legal framework is primarily the same. 

A year ago we reported on the court’s decision to drastically cut down the case by tossing out the class allegations and dismissing without prejudice plaintiff’s negligence and implied warranty claims.  New year, new complaint, new decision.  This time the court let plaintiff gallop out of the starting gate.

To refresh your memory – plaintiff owned a horse named Boomer.  When Boomer started experiencing leg swelling, a veterinarian administered an injection of an equine antibiotic manufactured by defendant called Excede.  Plaintiff alleges Boomer suffered an adverse reaction to the antibiotic causing the horse to experience persistent lameness and permanent damage to the musculature in his neck.  Knapp v. Zoetis, Inc. 2022 WL 989015, *2 (E.D. Va. Mar. 31, 2022).  Based on the decision it appears plaintiff ponied up two primary arguments.  First, defendant reported nearly 600 adverse events to the FDA, “some of which included similar symptoms to Boomer’s.”  Id. at *7 (emphasis added).  Second, Excede is an extended-release antibiotic that uses a “cottonseed oil suspension” in its delivery system.  Id. at *3.  Apparently that was enough for the court to say giddy up.

For this lap around the track, plaintiff re-alleged her express warranty claim (the only claim that survived the prior the motion to dismiss) along with amended claims for negligent failure to warn, negligent design and manufacture, and breach of implied warranty.  Plaintiff also sought punitive damages.  Id.   Under Virginia law, both negligence and implied warranty claims require a showing that the product was unreasonably dangerous for its ordinary or reasonably foreseeable use.  Id. at *5.  Here the drug was administered to Boomer for an off-label purpose.  But because plaintiff alleged defendant was aware veterinarians used the drug off-label, the court found such use was reasonably foreseeable.  Id. at *7. 

On design defect we must first reiterate a view often expressed in our posts – design defect does not make much sense as a theory of liability for a prescription drug.  As the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.”  Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2475 (2013).  So, even when plaintiff can articulate how a compound could be altered, the change would make the drug a different product.  So, on design defect we think the court should have said nay rather than spurring the claim along. 

In concluding plaintiff plausibly alleged a design defect, the court relies heavily on the “nearly 600” adverse events reported to the FDA — creating a classic case of damned if you do, damned if you don’t.  Plaintiffs attack defendants for failing to report adverse events and now for properly reporting?  Whoa!  The fact that the drug was FDA approved and that the FDA took no action upon receipt of this significant number, in the court’s view, of reported events should have cut against the plausibility of a design defect, not in favor.

Then there is the issue of a safer alternative design – a requirement under Virginia law.  The court’s reasoning on this one came up lame.  Plaintiff focuses on Excede’s extended-release mechanism.  Plaintiff argues that other equine antibiotics without such a mechanism do not cause the type of reaction Boomer experienced.  In fact, the safer alternative design plaintiff relies on is another antibiotic manufactured by the defendant called Naxcel.  Naxcel is a “non-extended release injectable” antibiotic.  Id. at *8.  Naxcel is also a different product.  Saying Naxcel is an alternative design is the same as saying defendants must stop selling Excede.  Plaintiff’s complaint may not talk in terms of withdrawing Excede from the market, but it is implied when they say Excede should really be Naxcel.  Afterall, defendant cannot just change the formulation of or the delivery mechanism of Excede without going through a new FDA application process.  The court overlooked all these issues holding instead that the question of whether the delivery mechanism would “fundamentally alter” Excede was a jury question.  Id. at *9.

The court allowed plaintiff’s manufacturing defect claim to proceed based on what appears to be an unsupported allegation that the cottonseed oil used in the drug may have been unrefined or improperly refined.  Sounds to us like this claim should have failed TwIqbal.  We will take this part of the decision in stride since it seems like a fairly case-specific issue.

That left just failure to warn – where the court seems to want to beat a dead horse.  Because defendant reported adverse events with Excede to the FDA and, because Naxcel did not have the same type of adverse events, defendant knew or had reason to know Excede had risks that should have been warned about. Id. at *10.  The court also found plaintiff adequately pleaded causation under the learned intermediary doctrine by alleging that defendant failed to warn both her and her veterinarian.  Id. at *9. 

The last thing the court considered was whether to strike plaintiff’s claim for punitive damages.  Punitive damages are not available for breach of contract.  So, the court had to decide if plaintiff’s warranty claims sounded in tort or contract.  Under Virginia law a claim sounds in contract if based on nonfeasance, whereas a claim based on misfeasance or malfeasance is a tort.  Because plaintiff alleges that defendant “affirmatively performed in such a way that injured her horse,” her warranty claims were based in tort and were sufficient to allow plaintiff to seek punitive damages.  Id. at *12-13.

All in all, this decision has left us with a bit of a long face.


Famous (and infamous) Illinois trial lawyer Clarence Darrow once said that he never wished a man dead, but had occasionally read some obituaries with great satisfaction.  (That same quote is sometimes incorrectly attributed to Mark Twain.) 


We’re no Darrow. We’ve never saved a client from capital punishment, or discredited a former presidential candidate in a courtroom, or made any sort of mark in the culture wars, or bribed a juror.  But we get a similar sort of satisfaction when we read a court opinion socking an overreaching plaintiff lawyer with sanctions.  We personally avoid seeking such sanctions unless absolutely necessary, but news reports of such sanctions occasionally deliver us a fresh bouquet of schadenfreude.  


Consider the case of Ingram v. Intili, 2022 IL App. (1st) 210656 (Ill. Ct. App. May 6, 2022). A plaintiff lawyer seems to have misused some arcane Illinois procedures in an effort to secure an unfair advantage.  The respondent (not the defendant, and thereby hangs the tale) did not like what the plaintiff lawyer did. Neither did the lower court.  Neither did the appellate court.  

Let’s take a brief legal tour of the Land of Lincoln, visit section 2-402 of the Code of Civil Procedure, sit for a spell with a Rule 224 petition, and pose for a selfie next to Illinois S. Ct. R. 137 – but not too close, because Rule 137 sanctions can bite. 


Rule 224, titled “Discovery before suit to identify responsible persons and entities,” allows the petitioner to engage in discovery to ascertain the identity of multiple persons and entities who may be responsible in damages.  Its only purpose is to ascertain the identity of possible defendants. Once that purpose (the only one, remember) is achieved, the petitioner can then file an actual case and conduct full-blown discovery against a party.  Rule 224 is wholly inapplicable when the identity of any potential defendant is known. 


Then there is a section 2-402 “summons in discovery,” aimed at “individuals or other entities, other than the named defendants, believed by the plaintiff to have information essential to the determination of who should properly be named as additional defendants in the action. Section 2-402 was originally enacted to provide plaintiffs in medical malpractice actions “with a means of filing suit without naming everyone in sight as a defendant by permitting a plaintiff to obtain discovery against a person or entity against whom he may have a claim.”  A person or entity named as a respondent in discovery per section 2-402 may be made a defendant in an action within six months, even if such an action would otherwise have expired during that six month period.  Section 2-402 was designed to make litigation more efficient.


What did the plaintiff lawyer do with Rule 224 and section 2-402, and why did that selfsame plaintiff lawyer get hit with sanctions under Rule 137?


The plaintiff represented by the plaintiff lawyer was a woman who claimed personal injuries from the Essure device. Instead of doing what so many other enterprising plaintiff lawyers have done by filing a product liability action against the Essure manufacturer, this plaintiff lawyer decided to be clever by filing both a Rule 224 petition and a section 2-402 summons in discovery against the treating doctor.  The plaintiff lawyer was attempting to force the doctor to identify the manufacturer’s sales representative.  The apparent advantage in pursuing this Byzantine route was that the manufacturer, not yet being a party, could not be pesky.  


The doctor several times pointed out that the plaintiff lawyer was doing things all wrong.  Rule 224 was facially inapplicable because it was undisputed that the plaintiff lawyer was aware of at least two proper defendants for the potential action: the device manufacturer and the doctor.  What the plaintiff lawyer should have done was file a proper lawsuit against the known defendant, and then named respondents in discovery under section 2-402 instead of filing a Rule 224 petition.  The plaintiff lawyer did not do that.  So that’s bad.


It gets worse. The section 2-402 “summons for discovery” filed by the plaintiff lawyer falsely stated that a complaint had already been filed.  In violation of the rule, which required attaching the complaint, the non-existent complaint was omitted from the summons.  

The doctor moved to dismiss this proceeding.  The plaintiff opposed unless the information sought by the illegitimate discovery was forthcoming.  Some information was provided, but rather than back down, the plaintiff lawyer doubled down and demanded to depose the doctor (before the putative manufacturer defendant would have even known of the litigation). Such a deposition was plainly beyond the permissible scope of a Rule 224 petition, which, again, is limited to identification of potential defendants.   


The doctor also sought sanctions for the plaintiff lawyer’s time-wasting, rule-violating harassment.  The trial court dismissed the plaintiff’s petition and imposed sanctions of more than $12K.  The plaintiff lawyer appealed, but found no joy in the Illinois appellate court.  Reviewing the sanctions order for abuse of discretion, the appellate court held that sanctions were appropriate because the proceedings instituted by the plaintiff lawyer  were “inapplicable and invalid from the outset.”  The initial filing used the wrong procedure, and then by demanding a deposition, the plaintiff lawyer went well beyond the scope of even legitimate pre-complaint discovery – and then tried to continue after the petition expired by operation of law.  


Again, the plaintiff should have filed a complaint (which never happened) and then should have used everyday, unloved-but-well-recognized post-filing discovery procedures.  The invalid summons was a “pleading” under the sanctions rule, and the attorney’s conduct demonstrated that the affair was not a mere “mistake made by a paralegal,” as counsel claimed.  Even if a paralegal was involved, the attorney was responsible for the paralegal’s actions. (Maybe blaming the paralegal was even worse than skirting all those Illinois rules.  Every paralegal we’ve ever worked with has been smart and hard-working.  For a lawyer to blame a paralegal for the lawyer’s own screwup would be really, really bad form.)  Meanwhile, action against the manufacturer/client was never filed.  


That last bit is at least as gratifying as the sanctions award.  

We’re not the font of all legal knowledge; we don’t claim to be.  Every now and then we come across material published by our colleagues at other firms defending prescription medical product liability litigation that we think would be valuable to our readers, so we ask if we can republish.  That’s how our 50-state survey on state tolling statutes came about.  It was a piece by another firm that we thought would be useful to our readers dealing with unsuccessful would-be forum shoppers, so we inquired, and they were gracious enough to allow us to distribute their research to our readers.

Recently, we were duly impressed by a Greenberg Traurig class action-related “advisory” entitled “Class Action Fairness Act Advanced Removal Strategies.”  It was written by Greenberg partners, Ryan C. Bykerk, and Christopher S. Dodrill.  This advisory is richly enough researched that it looks and reads like a law review article – which we at the Blog appreciate.  Here’s a thumbnail list of the CAFA topics covered:

  • Timing of CAFA removal, including defense ability to remove on their “own information” at any time.
  • How courts respond to plaintiffs gaming CAFA’s 100-member “mass tort” threshold.
  • Sufficiency of removal allegations concerning CAFA minimal diversity.
  • Citizenship of various types of entities involved in CAFA litigation.
  • Determining and pleading CAFA’s $5 million amount-in-controversy requirement.
  • Post-removal attempts by plaintiffs to destroy CAFA jurisdiction.
  • Defense-side jurisdictional discovery in CAFA cases.
  • Viability of successive CAFA removals.

We’ve uploaded a copy of this piece here, or if you’re so inclined, you can read it on Greenberg Traurig’s website, here.

On multiple occasions the Blog has addressed CAFA-related topics, occasionally with research posts but more frequently discussing new significant decisions.  We’re pleased to add this piece to the resources available to our readers.

California’s Proposition 65, which has spawned litigation over scientifically questionable “known to the state [of California] to cause cancer” warnings on such everyday products as cola drinks, coffee, beer, and soy sauce, see Riva v. Pepsico, Inc., 82 F. Supp.3d 1045, 1062 (N.D. Cal. 2015), took one on the chin recently in the Ninth Circuit at the hands of free speech under the First Amendment.

We can’t say it was unexpected – indeed, Prop 65 was one of the targets of the First Amendment’s prohibition on governmentally compelled speech that we identified in our 2019 post on American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (“ABA”).  And lo it has come to pass.

Continue Reading Ninth Circuit – First Amendment Prevails Over Prop 65