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We are headed to Guitar Town.  That’s Nashville to you.  Guitars are played and guitars (including the magnificent Gibson ES-335) are made there. We aim to sample plenty of live music and hot chicken. But the reason for our trip is the Defense Research Institute (DRI) Drug and Medical Device Conference.  Tomorrow we will be on a panel with two people who are much smarter than we are. The subject will be challenges to expert testimony.  As a tune-up for that panel, today we’ll go through a recent case that addressed such issues.  

Fisher v. Ethicon, Inc., 2022 U.S. Dist. LEXIS 158201 (C.D. Illinois Sept. 1, 2022), is yet another pelvic mesh case yielding notable rulings on expert admissibility.  In general, defendants have done fairly well in pelvic mesh remand cases. Fisher is consistent with that trend.  But it was not a complete across-the-board defense win.  One of the plaintiff experts offered opinions that the pelvic mesh was defective both in itself and because of the surgical technique required to implant it.  The defendant moved to exclude the opinion on the surgical technique, reasoning that the issue was the product not the technique.  The Fisher court sided with the plaintiff because the “product design includes not only the mesh sling that remains implanted in a patient’s body but inexorably the custom helical passers and specially selected surgical technique with which it was paired.”  Thus, according to the court, the safety of the surgical technique was relevant, because the product was sold as a kit to facilitate that technique and the technique was apparently part of the FDA’s approval of the product.  Inexorably, we are not delighted with that part of the opinion.  Inexorably, we will move on to the other, better parts.  

Aside from that ruling on surgical technique, the defendant prevailed in its efforts to limit the plaintiff experts. Perhaps most important, the defense succeeded in excluding a plaintiff expert’s speculative opinion that hypothetical additional clinical trials would have exposed product defects.  This issue is at the heart of the pelvic mesh litigation.  Putting aside all the nonsense about medical grade material and Material Safety Data Sheets, the key argument by plaintiff mesh lawyers is that the mesh should have gone through full-blown clinical trials instead of the 510(k) “shortcut.”  Besides the fact that such argument seeks to use jury verdicts to upend a well-established FDA regulatory regime, it also is an example of putting the rabbit into the hat. The rabbit is the assumption that clinical trials would have produced results that would have persuaded the FDA not to approve the product.  That is at least two would-haves.  In Fisher, the defendant pointed out that the expert had no support for those would-haves.  What was the plaintiff’s response?  The plaintiff said that the fault was the defendant’s for not asking the right questions at the deposition.  The Fisher court quite rightly rejected the plaintiff’s argument on this point was “sophistry at its worst.”  The plaintiff expert simply had “not made any showing that further clinical studies would show the existence of the flaws he alleges” in the product.  

The defense also stopped the plaintiff experts from testifying on corporate motive or intent.  The pelvic mesh MDL court had already entered this ruling, but the Fisher plaintiffs attempted “to wriggle out of that prohibition” based on the theory that the expert was not rendering “state of mind evidence” but was, rather, merely sharing factual testimony about the defendant’s party admissions.  Talk about sophistry! The Fisher court saw through this ruse as “another attempt to allow a ‘so-called’ expert to usurp the role of the jury.”  The “so-called” expert lacked first-hand knowledge of the company’s knowledge or intentions, had never been employed by the defendant, and had no qualifications to “divine” the defendant’s mental state.  The jury could read and interpret the defendant’s alleged admissions at least as well as the paid expert could.  

In many pelvic mesh cases the plaintiff trots out a pathologist to opine that pelvic mesh degrades.  The degradation theory is unproven, but that does not stop these plaintiff experts from solemnly intoning on them, though the specifics vary. In Fisher, the expert was a repeat player who likes to show the jury alleged mesh degradation via histological dyes “revealing cracks akin to bark on a tree.”  The Fisher court excluded the “bark” degradation theory because it lacked peer review, published support, and general acceptance.  The expert admitted that there was a way he could easily have physically tested the theory, but the expert did not do so. Oops.

Finally, that same non-clinician pathologist wanted to tell the jury that the product Instructions for Use (IFU) were inadequate and misleading.  The Fisher court held that the experience of a pathologist did “not appear to qualify him to opine about the specific risks of implanting mesh and whether those risks appeared on the relevant IFU.”  As is often the case with plaintiff mesh experts, ambition exceeded reality. Plaintiff lawyers like to talk about corporate greed, but few things show more greed than expert opinions.  

We are mostly content with the Fisher opinion.  That should not surprise you.  Johnny Cash wrote a song called “This Side of the Law.”  Surely, you know on which side of the law we and our fellow DRI attendees sit.  

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Bexis has just submitted revisions and updates to Chapter 4 of his treatise, Drug and Medical Device Product Liability Deskbook.  Chapter 4 is “The Federal Framework,” and one of the topics it covers is the use of claimed FDCA violations as the basis for state-law claims, including, most prominently, negligence per se.  Bexis addresses in depth a number of non-FDCA-based common-law defenses to negligence per se: (1) consistency with legislative intent; (2) the force-of-law requirement; (3) prohibition on creation of novel tort duties; (4) inapplicability of licensing statutes; (5) requirement of a specific standard; and (6) causation issues.  That means Bexis has been reading a lot (hundreds) of recent non-FDCA negligence per se cases, involving everything from traffic accidents to firearms to data breaches.

Continue Reading On Pleading Negligence Per Se
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The puppies are here!  We are delighted to follow up on our last post, wherein we announced that the mother of our standard-poodle-puppy-to-be was in the middle of giving birth.  We are thrilled to report that the final tally includes eight beautiful, healthy pups – four boys and four girls, three white and five blue (a beautiful steel-gray color when mature, though blue puppies are born black).  We are beyond excited and can’t wait to meet the babies and find out which will be ours.  (E-mail us if you want to see a picture!)

Today’s case discussion also follows up on a previous post. Back in 2018, we reported, with pleasure, about a smart (and favorable) express and implied preemption decision.  Today, in Gravitt v. Mentor Worldwide, LLC, — F. Supp. 3d. —, 2022 WL 3584620 (N.D. Ill. Aug. 22, 2022), the court deals – equally wisely – with the admissibility of the rebuttal reports of three of the plaintiff’s experts. 

Here is the background.  Gravitt involves the plaintiff’s claim that she was injured by the defendant’s silicone breast implants.  Per the case management order, the plaintiff served her initial expert disclosures and reports in February of this year, and the defendant served its disclosures and reports in April.  The deadline for the plaintiff to serve rebuttal reports was July 15.  On July 12, the plaintiff requested – and the defendant granted – an extension of the deadline, to July 18 at 9:00 a.m.  The appointed time came and went with no reports from the plaintiff.  A bit later in the day, the plaintiff’s attorney asked defense counsel for an additional two-week extension.  Defense counsel denied the request but gave the plaintiff until the end of the day to serve her rebuttal reports.   Later in the day, the plaintiff served a disclosure that identified three experts, but she included reports from only two of them. The third expert did not complete his report until July 31, and the plaintiff served it that day or shortly thereafter.  Not until August 2, two days after the expert completed his report and fully two weeks after the extended July 18 deadline, did the plaintiff move for an extension of that deadline. The defendant opposed the retroactive extension request and moved, on two different grounds, to exclude the other two experts’ rebuttal reports.

The court dealt first with the expert whose report was late.  As the court explained, the plaintiff argued that the lateness should be excused because the expert “experienced a ‘flare up’ of a certain medical condition on June 1, causing him to become confused about the report’s due date . . . .”  Gravitt, 2022 WL 3584620 at *1.   Specifically, “although Plaintiff’s counsel told him on June 2 that the due date was July 15, [the expert] avers that he mistakenly assumed from that conversation that it was July 31.”  Id. (citation omitted, smirk and eye-roll assumed).  The court explained that it was bound by precedent defining “excusable neglect,” emphasizing, “If the moving party fails to demonstrate genuine ambiguity or confusion about the scope or application of the rules or some other good reason for missing the deadline, she cannot establish excusable neglect regardless of how short the delay was or how little it prejudiced the opposing party.  Id. at *2 (internal punctuation and citations omitted).

In this case, the court held, the plaintiff failed, in two different respects, to demonstrate excusable neglect.  First, the delay in serving the report was inexcusable because, though plaintiff’s counsel “checked in” with the expert on June 23 because he had not responded to an earlier call, she did not “do what prudence demanded under the circumstances, which was to confirm the July 15 deadline.”  Id.   Second, plaintiff’s counsel did not seek an extension until two weeks after the deadline had passed, though she had known for weeks about the expert’s supposed “confusion.”   The court also pointed out that, although this analysis did not require a showing of prejudice, allowing the expert to serve his report two weeks after the extended deadline would “prejudice [the defendant] and materially impact the proceedings by requiring the court to push back” the deadlines for dispositive motions and motions to exclude experts.  The court concluded, “. . . Plaintiffs’ delay was not harmless, nor were they justified in failing to serve [the expert’s] rebuttal report, or to seek relief from the deadline, before the deadline passed.”  Id.

The court next addressed the defendant’s motion to exclude the plaintiff’s regulatory rebuttal expert as unqualified to offer the opinions in his report.  The defendant argued that the expert “ha[d] no experience in regulatory compliance for the medical device industry, and any remotely relevant experience he had ended in 1989,”  The court held that it did not even need to reach the merits of this argument because the plaintiff provided “no detail concerning [the expert’s] experience with or knowledge of the FDA,” when “left” – get this – a position in the “Bureau of Radiation and Medical Devices in Canada’s Department of Health and Welfare.” Id. at *3.  That’s right, an FDA “expert” who did not work at the FDA. Thus, plaintiff “failed to counter [the defendant’s] contention that [the expert] in unqualified to offer the opinions in his rebuttal report.”  As such, the plaintiff “forfeited any argument that [the expert] is qualified to offer the opinions in his rebuttal report.”  Id. Just for good measure, the court added the comment that, “[f]orfeiture aside, [the expert] is unqualified to offer the opinions set forth in his rebuttal report,” because his experience was “at best, tangential” to the issues on which he sought to testify.

Finally, the court considered the defendant’s motion to exclude the so-called “rebuttal report” of one of the plaintiff’s causation experts.  The defendant argued, and the court agreed, that the expert’s report was not rebuttal at all.  Because the so-called “rebuttal” opinions pertained directly to the causation element of the plaintiff’s claims – to the issue of whether the defendant’s product caused the plaintiff’s injuries – they belonged in the expert’s opening report.   Nor did the expert’s “few references to the defendant’s experts” suffice to make the report a proper rebuttal, particularly when the expert “sandbag[ged the defendant] with new citations to which its experts [had] no opportunity to respond.”  Id. at *4.

Beyond the correctness of Gravitt’s conclusions, we love this decision for the judge’s obvious impatience with the plaintiff’s lawyers and his intolerance for their cavalier sloppiness.  The plaintiff’s counsel flouted court-ordered deadlines, federal evidence rules, and the framework of the report sequence, and the judge wasn’t having it.  We’ll watch for future opinions in this case, as we never tire of fearless, no-nonsense jurists.  We thank Dustin Rawlin and Monee Hanna, of Nelson Mullins, whose victory this is, for letting us know. And we’ll keep you posted on the puppies!  In the meantime, stay safe out there.

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Last year we recounted a decision that denied a preliminary injunction to selfish New Mexicans who think that they have a right to endanger others by refusing to be vaccinated against the SARS-CoV-2 virus, which causes COVID-19. Specifically the court denied relief to a registered nurse who claimed that she has a right to treat patients in a hospital and a mother who claimed that her children have a right to display livestock at a state fair without being vaccinated. In denying the preliminary injunction, the court—the United States District Court for the District of New Mexico—held that the plaintiffs were unlikely to prevail on their constitutional and statutory claims. Confirming the accuracy of that prediction, the court has now dismissed the plaintiffs’ suit.

Consistent with precedent, Valdez v. Grisham, 2022 WL 3577112 (D.N.M. 2022), rejected the plaintiffs’ attack on a public health order requiring that all hospital workers and all who would enter the New Mexico State Fair grounds be vaccinated.

Turning aside the plaintiffs’ statutory challenge, the court held that the public health order did not violate the FDCA by requiring that plaintiffs be vaccinated with “unapproved” vaccines. The claim failed for two reasons. First, it rested on a false premise given that the FDA has in fact approved administration of the Pfizer vaccine for those 12 and older. Second, it misconstrued the FDCA, which “nowhere prevent[s] the state, or any other entity, from requiring certain individuals to be vaccinated against COVID-19. 2022 WL 3577112, at *5.

Plaintiffs’ constitutional claims fared no better.

The court found no merit to plaintiffs’ substantive due process claim. It began by rejecting the plaintiffs’ broad characterization of the rights purportedly at issue. The rights at issue were neither the right to engage in one’s chosen profession nor the right to raise one’s children as one sees fit. Rather, said the court, the supposed rights actually implicated were “the right to work in a hospital or attend the State Fair, unvaccinated and during a pandemic.” 2022 WL 3577112, at *7. Because these are not “fundamental” rights “deeply rooted in this Nation’s history and tradition,” they may be restricted so long as the restriction is—as in this case, the court found—rationally related to a legitimate governmental interest. Id.

The court also rejected the plaintiffs’ claim that the public health order wrongly deprives them of what they characterized as “the common law right to bodily integrity.” 2022 WL 3577112, at *7. To start, said the court, the public health order does not require anyone to get vaccinated. Rather, it simply conditions employment at a hospital or attendance at a state fair on being vaccinated. Because there is no fundamental right to attend a state fair and because even a fundamental right to practice one’s chosen profession may be “subject to reasonable health and safety regulations,” requiring vaccination as a condition for working in a hospital or attending a state fair does not violate substantive due process, the court concluded. Id. at *8.

The plaintiffs’ equal protection claim failed, said the court, because the rights actually at issue are not “fundamental” rights and there is a rational relationship between a legitimate governmental interest and the differential treatment of the vaccinated and unvaccinated.

Nor, held the court, does the public health order violate procedural due process. Given that the order is “generally applicable” to all individuals within designated classes, the plaintiffs are “not entitled to [process] above and beyond the notice provided by the enactment and publication of the [public health order] itself.” 2022 WL 3577112, at *14.

None of these conclusions should come as a surprise given longstanding Supreme Court precedent under which “it is within the police power of a state to provide for compulsory vaccination.” 2022 WL 3577112, at *11 (quoting Zucht v. King, 260 U.S. 174, 176, (1922), and citing Jacobson v. Massachusetts, 197 U.S. 11 (1905)). Hoping to avoid this dispositive caselaw, the plaintiffs argued that COVID-19 vaccinations are “gene modification therapies” rather than vaccinations because they use messenger RNA (mRNA) rather than actual virus to trigger an immune response. Like all other courts to have considered the issue, the Valdez court concluded that mRNA vaccines are vaccines and thus covered by Jacobson, which upheld a municipal vaccination mandate that allowed no exceptions.

Finally, the Valdez court held that the New Mexico public health order did not violate the constitutional prohibition on state laws that “impair” contracts. The state order did not impair the nurse’s employment contract because her employer had independently imposed a vaccination requirement. And it did not impair the mother’s contract for her children to display livestock at the state fair because was eligible to receive a complete refund (and her children could display their livestock at another state fair even without vaccination).

Once again, reason carries the day. Onward to full vaccination.

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The Minnesota State Fair, the biggest in the country, is going on now.  If you are lucky enough to attend, you can check out the butter sculptures, eat cheese curds, gaze at seed portraits of Prince, wave hello to our law school classmate Senator Amy Klobuchar, eat cheese curds, ride the big slide (though you might want to avoid that if you’ve seen some recent, scary YouTube videos of slide misadventures), pet a baby goat, and eat cheese curds.  Minnesota does a great job of serving up goodies.  


We consider Salier v. Walmart, Inc., 2022 WL 3579752 (D. Minn. Aug. 19, 2022), to be a fine, legal goody from Minnesota.  Salier is the latest battle in the ivermectin wars.  If those wars involve an assault by the crazies against the medical establishment, then Salier is a victory for the medical establishment.  And good thing, too.   We might gripe some (okay – a lot) (okay okay – too much) about court decisions, but the last couple of years have shown the judiciary to be one of the few reliable shields against conspiracy-mongering know-nothingism.  


The plaintiffs in Salier sued pharmacies that refused to fill prescriptions for ivermectin and hydroxychloroquine written by an out-of-state, online “controversial” doctor.  We will not express our own opinion about such doctors, but we will mention that, as we write this, we are gazing at a pond.  On the pond there are a pair of ducks.  Occasionally they make a noise.  Can you guess what that noise is?  

The plaintiffs mustered three legal theories: violation of the “right to self determination,” intentional infliction of emotional distress, and tortious interference with contractual relations.  When we contemplate these theories, we find ourselves again looking at the ducks.  They have now waddled out of the pond and are perched on the lawn. It looks as if they are about to leave behind souvenirs.  Can you guess what those souvenirs are?


Let’s turn to the Minnesota court’s quick dispatch of the Salier complaint.


First, there is no broad right to self-determination in Minnesota or anywhere else. The plaintiffs relied upon cases involving a patient’s right to informed consent, but that is a far cry from compelling a particular medical treatment.  At this point, we have to pause and praise the quality of prose in the Salier opinion.  Clear writing rests upon clear thinking. The Salier judge is clearly a clear thinker.  He can also craft an artful turn of phrase.  He points out that the sweeping new right advocated by the plaintiffs could lead to bizarre results on a host of controversial issues, such as abortion and assisted suicide.  The court reasoned that the “implications of recognizing the right asserted by the Saliers – not just the right to do whatever you want with your own body, but the right to force others to help you (so much for their right of self-determination) – would be mind-boggling, even if it were just limited to medical providers.” (Emphasis in original.) No state has recognized such a broad right, and the Salier court wasn’t going to be the first.  The bottom line is that healthcare providers cannot be compelled to provide medical treatment against their professional judgment.  

Second, the claim of intentional infliction of emotional distress is a goner because the refusal to fill a prescription for a drug that almost all authorities say should not be used for this purpose cannot be outrageous.  Minnesota law is similar to that of most jurisdictions when it comes to the tort of intentional infliction of emotional distress.  You might remember from law school that this tort was controversial from the start.   There was much concern about opening up the proverbial litigation floodgates.  Early cases involved truly outlandish things, such as mishandling corpses.  To cabin this potentially endless tort, Minnesota and other states imposed a requirement that the defendant’s conduct must be “extreme and outrageous.”  The pharmacies here did nothing outrageous.  They followed the “overwhelming weight of medical authority.”  The result might have been different if the pharmacies refused to fill the prescriptions because of some animus or political beliefs or bizarre corporate policy, but none of that was even hinted at here.


Third, the tortious interference cause of action fails for lack of any breach, plus the tort cannot be based on mere refusal to deal.  The plaintiffs alleged that the pharmacy’s refusal to dispense the ivermectin interfered with the online doctor’s performance of her contract to treat the plaintiffs. But the plaintiffs conceded that the online doctor did not, in fact, breach her contract. Nothing pleaded in the complaint suggests that the pharmacies did anything to hinder the doctor’s part of the bargain.  Moreover, the defendant pharmacies “took no affirmative action but merely refused to deal with the Saliers.” The defendant pharmacies did not, for example, do anything to prevent the plaintiffs from procuring ivermectin elsewhere.  If Minnesota has 10,000 lakes, it probably has at least as many pharmacies.  There simply was no interference of the type required under Minnesota law to prop up this rickety cause of action.  

Finally, even if there was a speck of merit to the plaintiffs’ lawsuit, it would be dismissed because the plaintiff failed to provide the necessary expert-review affidavit as required by Minnesota malpractice statutes. You are probably familiar with similar statutes that are in place all around the country. They are usually invoked in med-mal cases against doctors or hospitals.  But pharmacists, too, can qualify as health care providers.  Each of the plaintiffs’ causes of action “requires evidence that defendants violated the standard of care applicable to pharmacists.”  Accordingly, this lawsuit required the filing of an expert affidavit.  There was no affidavit, so that is an independent reason to dismiss the case. Because the plaintiffs did not demonstrate any “excusable neglect” in failing to supply the expert affidavit, the court dismissed the case with prejudice.  

In some ways, that last ruling could be the most interesting aspect of the case. Not everyone thinks of pharmacies as health care providers. But the cause of action might treat them precisely as such. If there is a failure to comply with a statutory requirement of an expert affidavit against the pharmacy, that is obviously a big deal if you represent the pharmacy. But it could also be a big deal if you represent a codefendant. Plaintiffs have been known to include a local pharmacy in a product liability case to defeat federal diversity jurisdiction. The plaintiff’s noncompliance with the expert affidavit requirement can help you prove fraudulent joinder and get the case into federal court.


If the Salier lawsuit were at the State Fair, it would be hustled past the fun house and funnel cakes and would be planted in the dunk-tank.  

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Today’s post is actually about a medical malpractice case.  But it involves the interplay between an FDA “Safety Communication” and punitive damages, so we thought it was worth looking at.

In Rivera v. Valley Hospital, Inc., 2022 WL 3650726 (NJ Aug. 25, 2022), plaintiff is the representative of the estate of a woman who passed away from leiomyosarcoma, a rare uterine cancer.  The decedent had been experiencing symptoms that caused her to seek treatment with a gynecologic surgeon.  She met with the surgeon 4 times prior to undergoing surgery.  At her second appointment, her surgeon informed her that her MRI revealed a uterine fibroid that required surgery.  Subsequent conversations with the decedent and between her physicians concerned the type of surgery; whether decedent would undergo a laparoscopic hysterectomy or a myomectomy—an open procedure that would have a longer recovery time and be more painful.  Ultimately, the decedent opted to have a hysterectomy.  That procedure involved the use of a power morcellation device—a device that cuts tissue into smaller pieces to allow it to be removed via a small incision.  Her surgeon’s records indicate he discussed the risk of morcellation of a malignancy with the decedent.  The decedent did not recall discussing a morcellation device but did testify that her surgeon told her he would “chop up” her uterus.  Unfortunately, the pathology following the decedent’s surgery revealed the leiomyosarcoma and despite treatment, decedent passed away about a year after surgery. 

Approximately six months before decedent’s surgery, the FDA issued a “Safety Communication” warning that the use of a morcellation device in uterine fibroid surgery “poses a risk of spreading unsuspected cancerous tissue.”  The FDA data showed that approximately .28% of woman with uterine fibroids have an unsuspected cancer and that use of the morcellation device can cause the tissue to spread into the abdomen and pelvis worsening the patient’s prognosis.  The communication advised patients and surgeons to “carefully consider alternative treatment options” and “discouraged” the use of the device in these types of procedures.  Id. at *5. 

Immediately following the FDA Communication, the hospital, its administrators, and surgeons (including decedent’s surgeon) began to discuss the issue and what steps they should take.  Within days, the hospital convened a “power morcellation group” tasked with drafting an informed consent form that would reflect the FDA’s concerns.   Work on the informed consent form went on for several months, but the actual form was never implemented either before or after the decedent’s surgery.

Following the decedent’s surgery, the FDA issued an updated “Safety Communication”, and this time recommended a black-box warning be added to the device’s label.  One month after the update, the hospital discontinued use of the device.  Id. at *7.

After discovery, which laid out the above facts, defendants moved for partial summary judgment to dismiss plaintiff’s punitive damages claims.  The trial court denied the motions finding there was an issue of material fact as to whether defendants acted with “wanton and willful disregard” for plaintiff’s safety.   Id.  Defendants sought leave to appeal which was denied by the appellate division but granted by the New Jersey Supreme Court.  The NJ Supreme Court reviewed the denial of summary judgment de novo. 

Punitive damages in New Jersey are governed by the Punitive Damages Act (“PDA”) which requires “clear and convincing evidence” of “actual malice” or “wanton and willful disregard.”  Importantly, “[t]his burden of proof many not be satisfied by proof of any degree of negligence including gross negligence.”  Id. at *10.  Before analyzing the facts, the court explained that the PDA was established to “enforce more restrictive standards in the awarding of punitive damages.”  Id.  Punitive damages cannot be awarded for careless, negligent, or even grossly negligent conduct.                 

Based on the facts, the court was unable to find clear and convincing evidence to support a claim for punitive damages.  Plaintiffs had no evidence that defendants were motivated by actual malice or a wanton or willful disregard for safety.  Notably, the FDA Communication was not enough.  The FDA did not recall the device, nor did it prohibit uterine fibroid surgery using the device.  As a matter of law, the FDA Communication was insufficient to establish a basis for punitive damages:

Given the purely advisory nature of the FDA Communication, any argument that seeks to treat the use of the power morcellator after that communication as per se evidence of wanton and willful disregard for [decedent’s] safety falls short of meeting the clear and convincing standard required by the PDA.

Id. at *11. 

As to decedent’s surgeon, while the records and informed consent form are not explicit regarding the use of the morcellation device, neither do they contain anything suggesting the doctor acted with malice to substantiate a finding of punitive damages.  Id. at *12.  Nor is there any evidence of a deliberate act or omission “with knowledge of a high degree of probability of harm to another with reckless indifference to the consequences.”  Id.  All medical procedures have risks and here the FDA noted a less than 1% risk of an unsuspected uterine sarcoma.  So, the FDA Communication did not satisfy the punitive damages requirement of a “high degree of probability of harm.” 

Finally, even if the medical providers acted negligently, plaintiff cannot simply recast negligence as wanton and willful based on the same alleged conduct.  Plaintiff could not articulate how the same conduct they alleged supports their negligence claim was also clear and convincing evidence of actual malice or wanton and willful disregard to support an award of punitive damages. Punitive damages are limited to exceptional cases, and this was not one of them. 

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This post is from the non-Dechert side of the blog.

After more than a month away at trial, we probably should not have picked a case that hit so close to home, so to speak.  Spear v. Atrium Medical Corp., — F. Supp. 3d –, 2022 WL 3357485 (E.D. Pa. Aug. 12, 2022), is a hernia mesh case brought by a frequent flyer lawyer via a cookie-cutter complaint not tailored to the law or facts of the case.  The decision considers a number of recurring issues, including the meaning of a Pennsylvania Supreme Court decision that reversed in part a case we won on summary judgment.  Even for an order on motion to dismiss, Spear was far too generous for the plaintiffs, at least for us.

We start with what should be a recitation of the basic facts of the case, except that the opinion omitted the basic facts.  The court indicated the hernia device at issue, the month when it was implanted, and the month when plaintiffs sued.  Curiously absent were the name of the implanting physician, where the device was implanted, that the device was available only by prescription, what injuries plaintiffs claimed, how he claimed they occurred, what intervention (if any) happened, and a number of other items we would have expected to be presented.  Are we just being curmudgeonly, like we might be if we pointed out that the decision often did not cite Pennsylvania state court decisions correctly?  Not only that.  As we have noted previously, the presentation of facts can foretell the rigor of the analysis to follow.  It did here.

The procedural history was presented.  Plaintiff sued the US manufacturer, its US parent (at the time of the implant), and its parent’s Swedish parent (at the time of the implant).  (The court did not mention that the manufacturer was sold in 2018.)  The US entities filed a motion to dismiss on 12(b)(6) and the Swedish entity filed a motion to dismiss both on lack of personal jurisdiction and on 12(b)(6).  We will take on the personal jurisdiction issue first, as it should have been very simple given the current Supreme Court precedent.  Since Bauman, it has been clear that there is no general personal jurisdiction over foreign entities simply because they have subsidiaries in the US.  Under Walden, specific personal jurisdiction over a non-resident defendant must be based on contacts with the forum created by the defendant that give rise to the claim.  When the Spear court addressed the Swedish indirect parent’s jurisdictional motion, it cited no Supreme Court or recent authority.  Without analysis, it concluded that:  “Plaintiffs have not established a prima facie case of jurisdiction. They have, however, made enough of a showing to warrant discovery on jurisdiction.”  Id. at *5.  The cite for the latter conclusion was “Toys “R” Us, Inc. v. Step Two, S.A., 318 F.3d 446 (3d Cir. 2003) (“[C]ourts are to assist the plaintiff by allowing jurisdictional discovery unless the plaintiff’s claim is ‘clearly frivolous.’ ”).”  We find this strange, not just because of the citation issues, but because Toys “R” Us predated Bauman and Walden by nine years.  As the Bauman court said, “it is hard to see why much in the way of discovery would be needed to determine where a corporation is at home.”  517 U.S. 117, _ n. 20 (2014).  The Swedish company was surely not at home in Pennsylvania for purposes of general jurisdiction.  In terms of specific jurisdiction according to the standards of Walden, one would expect there to be detailed allegations in the complaint relating to the direct actions of the Swedish company giving rise to liability.  In terms of whether there was a non-frivolous basis for a claim to be asserted against the Swedish company in Pennsylvania, one would expect the court to evaluate the allegations in the complaint.  None of that is presented in Spear, so it reads like a rubber stamp for unnecessary jurisdictional discovery based on a case from well before the tightening of the jurisdictional standards.  That is troubling.

The rest of the opinion had similar analytical and temporal issues.  The first up of the six asserted claims was strict liability design defect.  We will not attempt to do a full recap of all the posts and decisions on the issue of whether Pennsylvania recognizes such a claim for prescription medical products. (See here, here, here, and here)  Suffice it to say that it was long considered established law that it did not.  Over the last few years, there have been a number of decisions out of Pennsylvania federal courts addressing the question of whether such a claim can be maintained against the maker of a prescription medical device.  Just as drawing a line on applying the learned intermediary doctrine to some but not all prescription medical products makes no sense, so would drawing such a line on strict liability.  The strong majority of courts to consider this issue have applied the ruling from Hahn v. Richter, 673 A.2d 888 (Pa. 1996), which rejected strict liability in a prescription drug case, to cases over prescription medical devices.  Last year, the Pennsylvania Supreme Court accepted the Third Circuit’s request to consider this issue again, but that case was resolved before a decision. So, the issue remains open, at least to some.

Strangely, the origin of the new “debate” over this issue seems to have been language in the Pennsylvania Supreme Court’s decision in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), a prescription drug case.  The defendant won Lance at the trial court level because 1) the prescribing physician testified in deposition (taken by some young hotshot) that no change in the warning as to the risk of primary pulmonary hypertension would have changed his decision to prescribe a weight loss medication to plaintiff’s decedent because her extreme obesity presented significant health risks and 2) plaintiff had no strict liability claims under Pennsylvania law.  On appeal, the plaintiff was allowed to carve out a previously unrecognized claim for what is generously called “negligent design” but is more accurately called “negligent failure to withdraw a legally marketed prescription medical product.”  (We will skip the massive preemption issues with such a claim, but feel free to peruse some posts.)  The appellate courts did not reverse the dismissal of the strict liability counts—knocked out of the master complaint on preliminary objections, the Pennsylvania equivalent of 12(b)(6).  Instead, the line remained firm that Pennsylvania allowed negligence claims for prescription medical products—albeit with an unwarranted expansion—and not strict liability claims.

Fast forward to Spear.  The question of strict liability was framed as “whether Pennsylvania law per se excludes medical devices from strict liability.”  2022 WL 3357485, *1.  Clearly, this is the wrong question for a federal district court sitting in diversity.  Better would have been “does Pennsylvania recognize strict liability claims for prescription medical devices and, if this has not been decided, would it?”  After noting that most Eastern District of Pennsylvania cases to decide the issue have rejected strict liability—but without acknowledging the even stronger majority among other courts addressing the issue—the court looked to a footnote in Lance and general language from Tincher v. Omega Flex, Inc., 104 A.3d 328, 396 (Pa. 2014), a case about steel tubing used as a gas line.  Without analysis, the court stated “Given these decisions, there is little to support a prediction that the Pennsylvania Supreme Court would expand comment k to medical devices as a categorical exception from strict liability.”  2022 WL 3357485, *1.  Even setting aside that the case involves a prescription medical device, huh?

The cited language from Lance suggests little to support this facile conclusion:

Wyeth is quick to point out that many other jurisdictions have not implemented a blanket approach to comment k, as it pertains in the strict-liability arena, and, thus, it takes the position that such cases are irrelevant. We do not share Wyeth’s view, however, that blanket application of the commentary for purposes of strict liability and preclusion of negligence-based liability premises necessarily go hand-in-hand. Indeed, it is our perspective that this Court applied a rather one-dimensional analysis in its adoption of a blanket approach to comment k in the first instance. For example, the terse opinion in Hahn does not so much as mention, let alone evaluate, the reasons why many other jurisdictions had interpreted comment k to require a case-by-case assessment concerning the availability of its protections. Compare, e.g., Hahn, 543 Pa. at 560–63, 673 A.2d at 889–91,with Toner, 732 P.2d at 304–09.

We emphasize that we are not revisiting Hahn; rather, our point is only that the truncated analysis in the Hahn line offers a poor foundation for extrapolation. See generally infra section IV.

Lance, 85 A.3d at 452 n. 21 (internal citations as in original).  Nor does the language from Tincher that was apparently being cited:

In either case, this jurisdiction’s experience with the repercussions of attempting to articulate specific principles of liability of broad application in implementing the strict liability cause of action make us reticent to go far beyond the necessities of an individual case and embrace a broad new approach premised upon what may prove to be procrustean categorical restrictions.

Our reticence respecting the Third Restatement scheme is not a judgment on our part that, as a matter of policy, articulating categorical exemptions from strict liability is not a viable or desirable alternative. Courts, which address evidence and arguments in individual cases, are neither positioned, nor resourced, to make the kind of policy judgments required to arrive at an a priori decision as to which individual products, or categories and types of products, should be exempt.

Tincher, 104 A.3d at 396.

What followed was a bizarre discourse on how drugs are “intrinsically dangerous” because they “are comprised of biologics meant to interact with and have an effect upon human tissue.”  2022 WL 3357485, *2.  On the purportedly other hand,

Medical devices, at least before implantation, are inert.  They may not remain so, and their insertion may trigger a systemic response from the patient’s body, but their physical characteristics are significantly different from medications.  If, with proper choice of materials and proper methods of fabrication, an implant can be supplied that is not inherently dangerous, then the rationale behind comment k does not readily apply.

Id.  The typical allegations in surgical mesh cases might be instructive.  So might the statutory definition of a medical device, which includes an instrument that is “intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals.”  21 U.S.C. § 321(h).

Following this bit of shoddy analysis, the Spear court turned to plaintiffs’ failure to warn claim.  After blindly applying its prior reasoning on strict liability design defect to strict liability failure to warn, the court gave a cursory analysis of whether plaintiffs had properly pled their claim.  With a time warp worthy of Riff Raff and Magenta, the court managed to ignore TwIqbal in its analysis.  Instead, it looked to Pennsylvania’s ultimate requirement of proof of expert testimony to prove a prescription drug (!!!) failure to warn claim as a reason why these plaintiffs did not have to plead a viable claim for failure to warn up front.  Id. at *2.  This creative reasoning is quite contrary to TwIqbal.  Many tort claims, and pretty much all product liability claims, will ultimately require expert support, yet those plaintiffs still have to meet Rule 8 pleading standards.  It certainly does not take an expert to write some allegations that “The device’s Instructions for Use did not advise physicians of the true risk of [whatever allegedly happened to this particular plaintiff].  If they had, then Dr. [whatever the name of the implanting surgeon was] would not have implanted the device in plaintiff.”  This plaintiff did not even do this much and the Spear opinion does not provide the information to fill in those brackets.

Next up was the Lance claim for “negligent design.”  The court acknowledged that “Some decisions in this district deem [Lance language describing negligence in broad terms] to be dicta, and interpret Lance as limiting negligent design claims involving medical products solely to the theory that the product was too dangerous to market.”  Id. at *3.  Yet the court followed the other (minority) view that Lance opened the door to “a broader theory of liability to include the claim that sound design requires the product to be accompanied by warnings.”  Id.  It clearly did not.  Summary judgment on negligent failure to warn in Lance, which was not overturned on appeal, is what led to Lance’s creation of a new non-warnings claim in the first place.  As Spear’s remaining discussion of the issue showed, the court did not understand the difference between a warnings claim, a design claim, and the claim that the product should not have been sold at all.  Strangely, in a footnote on whether pleading an alternative design was required, the court noted that language in a Lance footnote was “best understood as related to the Court’s approval of a theory not previously recognized by Pennsylvania law:  that some products are too dangerous to market.”  Id. at *3 n.6.  We could go on, but we will refrain.

After dismissing warranty claims because plaintiff did not oppose that portion of defendants’ motion, the court seems to have discovered Rule 9, specifically (b), in considering plaintiff’s negligent misrepresentation claim.  We do not have a problem with the result—plaintiff had not provided sufficient detail, but got a chance to amend—although the reasoning left something to be desired.  Without deciding whether 9(b)’s heightened pleading standards apply to a negligent misrepresentation claim, the court cited 2001 and 2007 Eastern District of Pennsylvania cases for a “degree of specificity” standard.  If the court decides future motions to dismiss or for summary judgment, then we hope it can be more rigorous and look to recent law, including from relevant courts like the United States Supreme Court.

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If we advertised our blog as being non-drowsy, would that be false advertising?  We hope not.  

In Amara v. Publix Supermarkets, Inc., 2022 WL 3357575(M. D. Fla. August 15, 2022), the plaintiff claimed that a cough syrup was falsely advertised as non-drowsy.  According to the plaintiff, the cough syrup contained an ingredient called DXM that, contrary to the label, could make people sleepy.  (Call it a doze response.) The plaintiff said he would not have bought the medicine, or would have paid less for it, if he knew the narcoleptic truth.  He filed a putative class action based on various state consumer fraud laws, breach of contract, breach of warranty, etc., as well as the federal Magnuson Moss Warranty Act (MMWA).  He wanted his money back and he wanted an injunction. The defendant moved to dismiss the case because the plaintiff lacked standing , because the claims were preempted by the federal Food Drug and Cosmetic Act (FDCA) and because the claim of non-drowsiness was not deceptive. 

The Amara court held that the plaintiff had alleged an economic injury of overpayment, but had not alleged  “any future harm to himself that is real and immediate and/or certainly impending.”  He offered “only a speculative and conjectural statement that he intends to purchase the Product at some future date.”  Thus, the defendant’s motion on lack of standing was granted with respect to injunctive relief.  

But the plaintiff had alleged an economic injury of overpayment, so he had standing as far as that goes.  Did that mean that such claim could proceed? No, a defense victory rode in on a stallion called preemption.  For the plaintiff, that stallion must have seemed more like a nightmare.  

Congress expressly preempted certain claims with respect to over-the-counter (“OTC”) drugs. With limited exceptions, “no State or political subdivision of a State may establish or continue in effect any requirement…that is different from or in addition to, or that is otherwise not identical with, a requirement” for OTC drugs in the FDCA.  21 U.S.C. § 379r(a).  The FDA issued a final monograph for cough medicines that sets forth the specific disclosures that manufacturers must make on labels for products that contain DXM. That monograph mandates warnings about drowsiness for cough medicines containing  another ingredient, but does not require a disclosure of drowsiness as a side effect for products that contain DXM. 

The plaintiff attempted to sidestep this problem by arguing that because the defendant voluntarily added the affirmative misrepresentation of “non -drowsy” to the cough syrup labeling, requiring it to remove that statement would impose no additional disclosure requirements.  That is, the plaintiff said he was not seeking to add a drowsiness warning to the medicine; rather, he merely sought removal of the term “non-drowsy,” which he claimed was false and misleading. 

That is certainly clever. Most sophistry is.  The plaintiff invited the court to hold the defendant liable for labeling the product as “non-drowsy” when such labeling complied with the FDA’s Monograph.  The court declined that invitation.  According to the court,  “[i]f successful, this litigation would do exactly what Congress, in passing section 379r of the FDCA, sought to forbid:  using state law causes of action to boots trap labeling requirements that are ‘not identical with’ federal regulation.”  Accordingly, the court held that all of the plaintiff’s state-law claims were preempted by the FDCA because they sought to impose a labeling requirement that is “different from or in addition to, or that is otherwise not identical with, a requirement” for OTC drugs in the applicable regulations.

What about the plaintiff’s solitary federal claim under the MMWA?  Federal preemption does not bar federal claims.  But “a breach of warranty claim under the MMWA is dependent upon a viable underlying state breach of warranty claim.”  Because the underlying state-law warranty claims were dismissed, the MMWA claim would be dismissed as well. Additionally – and this is a lesson not to sleep on technicalities — the complaint failed to meet the requirement under the MMWA that the amount in controversy for any individual claim exceeds $25, since the plaintiff claims he purchased the product for approximately $4.99.

Here’s a delicious nightcap: because federal preemption cannot be cured by amendment, the court granted dismissal of the entire case with prejudice.

That’s Amara.  It’s a preemption wake-up call.  

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We came across something the other day that we don’t see very often, or really ever. The plaintiff in a medical device case served a request to inspect the two defendants’ manufacturing facilities, claiming that he was entitled to observe the premises where the device was made.  Not so fast, said the defendants.  And with good reason. 

These kinds of requests are probably not unprecedented, but we are unaware of any published order that addresses them.  We personally have seen a request for inspection of a medical device manufacturing facility only once.  That was in or about 2000, when a now non-existent medical device manufacturer voluntarily withdrew certain products from the market.  Eager to demonstrate product quality, a vice president posted a video on the company website inviting people to come visit the factory.  The video did not go viral—this, after all, was the pre-Instagram, pre-TikTok early 2000s.  But still, some enterprising plaintiffs’ attorneys wrote polite letters saying, “We accept, when shall we stop by.”  D’oh! 

Those inspections did not happen, and neither did the facility inspections that the plaintiff requested in Thelen v. Somatics, LLC, No. 8:20-cv-1724, 2022 U.S. Dists. LEXIS 146584 (M.D. Fla. Aug. 16, 2022).  The plaintiff in Thelen served his request under FRCP 34, which sure enough allows a request “to permit entry onto designated land or other property possessed or controlled by the responding party.”  Rule 34(a)(2).  There are, however, limits, hinging mainly on the relevance of the inspection and the value of the inspection balanced against the burden: 

[A] court evaluating a request to permit entry under Rule 34 will consider the relevance of the inspection and balance the value of the information sought with the burden of the proposed intrusion.  Further, . . . the court must limit the frequency or extent of discovery otherwise allowed . . . if it determines that: (i) the discovery sought is unreasonably cumulative or duplicative, or can be obtained from some other source that is more convenient, less burdensome, or less expensive.

Thelen, at *4 (internal quotes omitted).  This standard is not unfamiliar, nor is the requirement that a party seeking a protective order bears the burden of showing the necessity of the order and a “particular and specific” showing of facts.  Id. at *4-*5. 

The defendants in Thelen were on solid ground.  The plaintiff argued that the inspection was relevant because (1) he was entitled to observe the “premises and conditions of where the device is made” and (2) the inspection would yield “relevant information regarding Defendant’s liability and their respective roles.”  Id. at *5. 

Let’s pause here.  The first argument obviously proves too much—if this plaintiff is “entitled,” then so is every other plaintiff, which cannot be the case.  The second argument merely mouths discovery buzzwords (“relevant information regarding liability”), which are not compelling and do not explain how the plaintiff could not get the information through other methods. 

What did the defendants say?  First, no relevance.  One defendant reminded the district court that the plaintiff had not alleged a manufacturing defect, and the other asserted that the plaintiff’s devices were not manufactured there.  Second, they both highlighted the undue burden.  Counsel would have to travel to both facilities.  Id. at *8.  Further, an inspection would unnecessarily interrupt their manufacturing operations, and in the case of one defendant, “the facility is also the residence of its president, where he lives with his family.”  Id. at *6-7.  (Wow, talk about the lack of separation between work and personal life; that is one company person who has taken pandemic-era “work at home” very seriously.) 

The district court probably could have stopped there, but when considering that the plaintiff had not fully tried other, less intrusive means of discovery, the court had little difficulty ruling that “[t]he burden of the requested discovery outweighs its likely benefit.”  Id. at *7.  Both defendants represented that they would respond to interrogatories on the product’s manufacturing if the plaintiff were to propound them.  Id.  Moreover, the plaintiff already had some of the information through interrogatory responses, documents, and a deposition of one defendant’s president.  That witness did not know about the other defendant’s processes, but the remedy there was to take the deposition of someone who knew—which the plaintiff had not done. 

All this added up to good cause for preventing the inspections and an order denying the plaintiff’s motion to compel.  As we observed at the outset, this is not a scenario that we have often seen, but we are sure that if you have, you will let us know. 

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