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We just bought tickets for ourselves and a dear visiting colleague to see Barry Manilow in concert next month.   We love everything about Barry – his songwriting (we orchestrated many a youthful breakup with “Even Now” played over and over again), his chutzpah (just shy of his 79th birthday, he premiered a new musical, to raves, at the National Yiddish Theatre Folksbiene) and his unabashed and unapologetic joie de vivre and showmanship.  The first time we saw Barry in concert, we were young, in love, and spending the summer at the Jersey Shore.  The first live strains transport us back to those breezy days when we thought we could wish anything into reality simply by believing it enough.

We know better now, of course.  As does the plaintiff in today’s case, which turns on whether a plaintiff can satisfy Twiqbal by pleading facts “on information and belief.”  In Warren v. ResMed Corp., 2022 U.S. Dist. LEXIS 114447 (S.D.N.Y. June 28, 2022), the plaintiff alleged that her husband/decedent died because of a malfunction of the defendant’s ventilator.  (The decedent suffered from a degenerative neurological condition that affected his ability to breathe.)   The complaint alleged that the plaintiff found her husband unresponsive and observed “a gap or opening between the face mask” of the ventilator and the decedent’s face, and that “the gap impaired the functioning of the ventilator in a manner which should have caused an alarm to sound but did not.”  Warren, 2022 U.S. Dist. LEXIS 114447 at *3.  She filed suit in New York state court, and the defendants removed the case to the Southern District of New York.  She asserted all of the usual product liability claims sounding in strict liability, negligence, and breach of warranty, and the defendants moved to dismiss the failure-to-warn and breach of express warranty claims.

In her failure-to-warn claim, the plaintiff alleged that, “[u]pon information and belief,” the decedent’s doctor was provided with a User Guide that one of the defendants prepared and that, she alleged, contained inadequate warnings.   Similarly, in the breach of express warranty claim, the plaintiff alleged, “upon information and belief,” that the doctor and the decedent had “received, read, and reviewed” the defendants’ User Guide and Patient/Caregiver Instruction warranting “that the ventilator was fit, was reasonably safe, capable, and was of merchantable quality.”  Id. at *4-5.  In their motion to dismiss, the defendants argued that the plaintiff’s warnings and warranty claims failed because “the facts alleged ‘upon information and belief . . . [were] not peculiarly in the possession and control of the defendant,” and the complaint did not “contain a statement of facts upon which the beliefs [were] founded.”  Id. at *8 (internal punctuation and citation omitted).  The defendants contended that, “absent such a factual basis, the relevant allegations [were] purely speculative and [could not] provide a basis for” the claims.  Id.  

And the court agreed.  With respect to the failure-to-warn claim, the court held that the complaint “fail[ed] to state a claim because it [did] not plausibly allege that [the doctor] received inadequate warning from the Defendants.”  Id. at *9.  The court continued, “Although the [complaint] is replete with allegations concerning the substance of the allegedly “inadequate” warnings, it does not identify a single fact that supports the Plaintiffs’ ‘belief’ that [the doctor] received the documents in question.” Id. at *9-10.   “As a result,” the court concluded, “the allegation that [the doctor] received the relevant warnings from the Defendants is wholly conclusory.  Because the Plaintiff does not adequately allege that [the doctor] received the relevant warnings, the [complaint] fails to state a claim for failure to warn.”  Id.   This is akin to the “failure to read” argument we regularly make in our prescription drug and device cases:  if the doctor never read the warnings, the allegedly-inadequate warning could not have been a proximate cause of the plaintiff’s injuries.  (You can find our 50-state failure-to-read survey here.)

Similar deficiencies doomed the breach-of-express-warranty claim.  The defendants argued that the plaintiff’s “upon information and belief” pleading failed to adequately plead “the existence of a material statement amounting to a warranty” and “reliance on the warranty.”  The plaintiff countered that it would be “counterintuitive to assume” that the doctor did not receive and rely on the defendants’ express warranty, and that dismissal would be premature because discovery would elucidate the relevant facts.

The court emphasized that the complaint was “bereft . . . of any facts that would permit the inference” that the doctor or the plaintiff read and relied on the defendants’ express warranties and that the deficient pleading was not cured by the plaintiff’s conclusory assertion that it would be “counterintuitive” to assume that she was incorrect in her “information and belief.”  The court concluded, “Because the Plaintiff’s allegation that [the doctor] received and relied upon the documents in question” was not “accompanied by a statement of the facts on which the belief [was] based,” the express warranty claim failed as a matter of law.  Id. at *13-14 (internal punctuation and citations omitted).

Finally, the court rejected the plaintiff’s argument that she should be permitted discovery to develop the facts of her claim, stating that “a plaintiff who has failed adequately to state a claim is not entitled to discovery”; rather, “discovery is authorized solely for parties to develop the facts in a lawsuit in which a plaintiff has stated a legally cognizable claim, not in order to permit a plaintiff to find out whether he has such a claim.”  Id. at *14 (internal punctuation and citations omitted).

The plaintiff sought leave to amend the complaint to plead additional facts to support her claims.  The court explained that, under Second Circuit precedent, amendment was “not warranted . . . absent some indication as to what a plaintiff might add to its complaint in order to make it viable,” and this plaintiff “had not identified what new information she would include” if permitted to amend.  Id. at *15 (internal punctuation and citations omitted).  Nevertheless, the court permitted the plaintiff to move for leave to amend, with the motion to include a memorandum of law explaining how the amended complaint would survive a comparable motion to dismiss.

This last is a nice touch, and one we’ve not seen before.  We like this decision, obviously – we favor anything that forces plaintiffs to marshal facts to back up their claims before they file their lawsuits.  We’ll let you know if we hear anything further on this.  In the meantime, fire up some classic Manilow music, and stay safe out there.

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As we have previously observed, limits on personal jurisdiction matter because the outcome of litigation is heavily influenced by where a case is filed. Since the Supreme Court confirmed the narrow confines of general jurisdiction in Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011), and Daimler AG v. Bauman, 571 U.S. 117 (2014), plaintiffs, always eager to engage in litigation tourism, have doggedly tried to expand the bounds of specific jurisdiction, as we reported here, here, and here, for example.

But, because general jurisdiction—which allows a defendant to be sued on any claim, even if it has no relationship to the forum state—is far more potent, plaintiffs have devoted much of their effort to promoting an expansive theory of jurisdiction by consent. Under plaintiffs’ theory, a corporate defendant voluntarily subjects itself to general jurisdiction in a state by registering to do business in that state. Because nationally active corporations such as drug and device manufacturers are registered to do business in every state, adoption of plaintiffs’ jurisdiction-by-registration theory would effectively abrogate Goodyear and Daimler, which together held that a corporation is subject to general jurisdiction only where it is incorporated or headquartered.

Most states have rejected jurisdiction-by-registration. Next term, in Mallory v. Norfolk Southern Railway, No. 21-1168, the Supreme Court will decide whether the theory is consistent with due process.

Until then, lower courts continue to address the theory. Today we report on Bradley v. Globus Medical, Inc., 2022 WL 2373441 (Wash. Ct. App. 2022), in which Washington’s intermediate appellate court held in a medical-device case that registering to do business in a state does not constitute consent to jurisdiction there.

Bradley is odd in that the plaintiff argued that registration to do business in Washington constituted consent to specific rather than general jurisdiction there. That argument doesn’t make any sense because a plaintiff can establish specific jurisdiction whether or not a defendant is registered to do business in a state if the plaintiff’s claim arises from or relates to the defendant’s in-state conduct, which it must for there to be specific jurisdiction. The Bradley plaintiff presumably invoked specific rather than general jurisdiction because an earlier Washington case, Washington Equip. Mfg. Co. v. Concrete Placing Co., 931 P.2d 170 (Wash. Ct. App. 1997), squarely forecloses any general-jurisdiction-by-registration argument. And she was presumably invoked the defendant’s registration to do business in Washington because her claims did not arise from the defendant’s in-state conduct. In other words, the plaintiff was effectively arguing for general jurisdiction despite claiming to argue for specific jurisdiction.

The misdirection didn’t matter. Taking the plaintiff’s argument at face value, the Bradley court rejected the contention that registering to do business in a state constitutes consent to specific jurisdiction in that state.

As the court noted, “[d]ue process requires that three elements be met for a court to exercise specific jurisdiction: (1) that purposeful ‘minimum contacts’ exist between the defendant and the forum state; (2) that the plaintiff’s injuries ‘arise out of or relate to’ those minimum contacts; and (3) that the exercise of jurisdiction be reasonable, that is, that jurisdiction be consistent with notions of ‘fair play and substantial justice.” 2022 WL 2373441, at *3 (quoting Burger King Corp. v. Rudzewicz, 471 U.S. 462).

The court held that mere registration to do business in a state satisfies neither of the first two elements.

Citing Walden v. Fiore, 571 U.S. 277 (2014), the court held that registration by itself does not establish sufficient “minimum contacts” with a state because “[a] corporation might qualify to do business in states in which it never undertakes business or establishes a presence beyond appointing a registered agent.” 2022 WL 2373441, at *3.

And, said the court, registration to do business does not mean that a claim arises out of or relates to a corporation’s in-state conduct. The court held that even if the plaintiff had alleged that her surgery was performed in Washington that alone would not meet the arising-out-of-or-relating-to standard because she “did not hypothesize how the hardware and screws allegedly designed and manufactured by [the defendant] came to be used in her surgery through some deliberate reaching out into Washington.” 2022 WL 2373441, at *3. “The fact that [the defendant] is registered to do business in Washington does not fill that gap,” the court held, because “being registered does not mean a corporation has activities in Washington or any presence beyond its registered agent.” Id.

The consensus against jurisdiction-by-registration continues to hold. Check back later this year to hear how the Supreme Court decides Mallory.

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It is beach weather, but which beach? The Jersey shore is close, has fun boardwalks and rides, and offers the comfort of the familiar. Then again, you must pay to get on sand covered with New Yorkers. The Outer Banks are lovely, with dunes, wild horses along the surf, splendid lighthouses, and the spot where the Wright Brothers flew into the modern age. Then again, OBX is nine hours away. It also is creepy-crawling with New Yorkers.

How to choose? We thought about heading to the spot with law friendlier to the right side of the v. If we’re going to fritter money away on overpriced accommodations and restaurants, why not at least patronize a place that gives us and our clients a fair shot? But then what shall we do with a case like King v. Ethicon, Inc., 2022 WL 2341633 (D.N.J. June 29, 2022), in which a New Jersey court applies North Carolina law to trim back a typically overpleaded pelvic mesh complaint? The no-nonsense disposition of the King remand court contrasts vividly with the lassitude with which similar issues were treated (or not treated) in the mesh MDL court. Because this same plaintiff’s case languished for four years in a mesh MDL (after already not being filed until 10 years after surgery), before plaintiff voluntarily dismissed it (details in the opinion), that contrast is particularly dramatic.

The King complaint was initially filed in the S.D. West Virginia mesh MDL in 2014. The plaintiff lived in North Carolina, and that is where she had the pelvic mesh implanted. The defendant was headquartered in New Jersey. The plaintiff brought claims for strict liability failure to warn, design and manufacturing defect, misrepresentation, gross negligence, and violation of the New Jersey consumer protection act. The plaintiff voluntarily dismissed her complaint in 2018 pursuant to an MDL court order permitting her to refile within five years if she underwent a revision surgery. The plaintiff had her pelvic mesh removed by a doctor who does many such removals and shows up in many such lawsuits. The plaintiff refiled her complaint in New Jersey federal court in October of 2021. The defendant moved to dismiss several of the claims and to limit the negligence claims.

The King court’s Rule 12 opinion quickly cut the complaint down to two surviving claims: negligent design and negligent failure to warn. One of the reasons the King court was able to lay waste to so many of the plaintiff’s causes of action was the application of North Carolina law. In our defense hack mind we’re going to Carolina. North Carolina does not recognize strict liability at all, does not recognize independent product liability causes of action for failure to test, failure to inspect, or failure to train physicians, and does not recognize negligent misrepresentation as a personal injury cause of action. In short, North Carolina has uncommonly sensible laws governing product liability. Add that to a very intelligent, ethical Attorney General, the fact that one is never very far from a Brew Thru or Duck Donuts, and we might very well point our car due south for summer vacation.

But remember that it was a smart New Jersey judge who authored the King opinion, and not all of the goodies came out of North Carolina law. For example, the manufacturing defect claim in King was a goner because the plaintiff did not “plausibly allege that her implanted TVT deviated from Defendants’ design specifications.” In fact, other allegations in the complaint belied the manufacturing defect claim, such as when the plaintiff alleged that the mesh device implanted was “in the condition directed and expected by … Defendants.” There was no allegation of any problem with the manufacturing process. That spelled the end of the manufacturing defect claim.

In addition, the fraud/fraudulent concealment claims in King flunked the specificity requirement of Fed. Rule Civ. P. 9(b)). The plaintiff did not adequately plead the “contents” of any misrepresentations. She complained about “marketing” and “promotional materials,” but never identified any particular document or statement. The plaintiff also alleged constructive fraud, but could not show even a shadow of a fiduciary relationship between her (or her doctor) and the medical device manufacturer.

The plaintiff ended up conceding that her invocation of the New Jersey consumer fraud statute was misplaced because the New Jersey statute cannot apply extraterritorially. She tried switching to the North Carolina Unfair Trade and Deceptive Practices Act, but that claim also fell short of the requisite Rule 9(b) particularity.

Finally, the plaintiff’s gross negligence claim got Twiqballed out of court. A claim for gross negligence requires a plausible allegation of “wanton” conduct in addition to the usual elements of negligence. In King, the plaintiff lobbed in general accusations that the defendant withheld information about product risks, but never cited any “factual content” sufficient “to raise Plaintiff’s right to relief above the speculative level.”

Unlike the four years that this same case sat around with nothing happening in the MDL, within seven months, the King case was reduced to its essentials, and the parties can now focus on case-specific issues like how the plaintiff’s initial 10 year wait to file suit can possibly avoid the statute of limitations.

The King case says something good about product liability law in both New Jersey and a North Carolina. So we are no closer to deciding where to take our flip-flops, cooler, and floaties. Maybe we’ll look up some Massachusetts cases. We’re kind of jonesing for a Cape Cod lobster roll.

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Today’s case – Smith v. Hi-Tech Pharmaceuticals, Inc., — S.E.2d –, 2022 WL 2285920 (Ga. Ct. App. Jun. 24, 2022  — does not break new ground.  But it is a published decision by a state appellate court and for that reason, it deserves some attention.

Plaintiff, a resident of Washington, DC, brought a single claim under the District of Columbia Consumer Procedures and Protection Act (“DC CPPA”) alleging that defendant manufactured dietary supplements containing methylsynephrine which plaintiff claims is an unapproved drug ingredient.  By omitting that fact, plaintiff alleges defendant’s labeling was misleading. Id. at *1.  The trial court dismissed the claim as both impliedly preempted under Buckman and as raising issues that are within the primary jurisdiction of the FDA.  Id. at *2.   The Georgia Court of Appeals disagreed on preemption but agreed on primary jurisdiction.

While a ruling against preemption is disappointing, the holding is narrowly tailored to the DC consumer fraud statute and dietary supplements.  First the court discussed express preemption.  The labeling of dietary supplements is governed by an amendment to the FDCA known as the Nutrition Labeling and Education Act (“NLEA”).  NLEA contains an express preemption clause prohibiting states from establishing any labeling requirement that is not identical to the requirements of the NLEA.  Id.at *3.  However, if the state law requirements mirror or parallel the federal requirements, it is not preempted.  It is a violation of the DC CPPA to misrepresent or fail to state a material fact.  Id.at *4.  Similarly, while the FDA’s authority over dietary supplements is more limited than over drugs and devices, the FDCA does require supplement labels to be truthful and not misleading.  Since both acts require the labeling of dietary supplements not to be misleading, the court found the claims were parallel and therefore, the federal act did not expressly preempt the state act.  Id.at *5.

On implied preemption, the trial court relied on Buckman to find that plaintiff’s attempt to enforce the FDCA was preempted.  Not surprisingly, most of the cases relied on by defendant regarding Buckman involved medical devices or OTC drugs – products subject to stricter FDA requirements and control than dietary supplements.  The appellate court found Buckman inapplicable to dietary supplements because of the NLEA’s express savings clause: “The NLEA shall not be construed to preempt any provision of State law, unless such provision is expressly preempted.”  Id.  That’s pretty much the only reason Buckman did not apply.

Fortunately, that did not end the inquiry.  “Primary jurisdiction is a judicially created doctrine whereby a court of competent jurisdiction may dismiss or stay an action pending resolution of some portion of the actions by an administrative agency.”  Id. at *6 (citation omitted).  In other words, if a court finds that there are technical or policy questions that should be addressed first by the regulatory agency with authority over the industry, the court has discretion to defer to the agency.  Here, the primary questions were whether methylsynephrine is a dietary ingredient as that term is defined by the FDCA and whether it was safe, and at what dosages.  Plaintiff argued that FDA had already decided the question based on warning letters it issued.  But as many other courts have also ruled, warning letters are not final agency action and therefore not conclusive.  Id.at *8.  Therefore, the court did not abuse its discretion in invoking the primary jurisdiction doctrine.

Without preemption, the court’s dismissal with prejudice was overturned, but the case has been remanded to the trial court to decide whether a dismissal without prejudice or a stay pending FDA action is appropriate.  Either way the case will await a final agency action, which could moot the issue or send case back for round two on preemption.

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We have a case going on where the plaintiff wants to preclude the use of a term found in his medical records to describe something that happened to him in the past that is highly relevant to the claims and injuries in the case.  Instead of using the actual term, which was also used in treater depositions that will be played at trial—appropriately, because the term was in the records generated by those treaters—the plaintiff wants to use a substitute term that he finds less inflammatory.  Using a different term may have at least two consequences:  1) the jury may have a misimpression about what happened to plaintiff or 2) the jury may end up hearing a substitute term that sounds even worse.  Part of plaintiff’s argument is that, by hearing the correct term from the records, the jury may infer that the injuries he sustained well before the device at issue was implanted were because he was engaged in criminal activity, which is also excludable.  We are being vague here on purpose, but you cannot always avoid using the right term just because someone listening may misinterpret it or find it too strong.

This brings us to Fed. R. Civ. P. 21, the last two sentences of which provide:  “On motion or on its own, the court may at any time, on just terms, add or drop a party. The court may also sever any claim against a party.”  “Dropping” a party from a case is a surprisingly casual way for the Rules to describe “nonjoinder,” the term in the title for Rule 21.  That pales in comparison, however, to the use of “sever” to describe breaking up one case into more than one case.  Arteries, spleens, and limbs get severed.  A medical intervention that requires an incision into an organ to achieve a life-saving outcome would not be described as “severing,” which sounds far more violent and involuntary.  Federal district courts wield this authority to sever a case without any party requesting it.  Presumably, this is consistent with the exhortation in Fed. R. Civ. P. 1 that the Rules should be “construed, administered, and employed by the court and the parties to secure the just, speedy, and inexpensive determination of every action and proceeding.”  That sometimes means taking a case with fourteen plaintiffs and chopping it up into fourteen cases with one plaintiff each.

That is what happened in Ellis v. Evonik Corp., No. 21-1089, 2022 U.S. Dist. LEXIS 95318 (E.D. La. May 27, 2022).  This was a single action with fourteen plaintiffs, including representatives of decedents, suing two petrochemical companies over cancer allegedly caused by the airborne release of ethylene oxide from their facility.  The decision involves more than severance, but that is that part that drew our attention.  We can dispense with the rest fairly quickly.  One of the defendants stopped operating the plant in 1999, so the two plaintiffs whose claimed exposure started after 1999 had no viable claims against the earlier defendant.  Id. at *5.  (No Conte-esque liability theory was offered up, which further supports how cockamamie an innovator liability theory is for a drug.)  The plaintiffs all filed more than a year—Louisiana’s “prescription” period, which is what the Pelican State calls statutes of limitation—after their respective diagnoses.  That meant the court analyzed the contra non valentem (“the discovery rule” in Cajun-accented Latin) and continuing tort exceptions according to the pleadings.  The results depended on the defendant and whether the case involved a living plaintiff, but the dismissals came with leave to amend.  Id. at **7-26.  Defendants also succeeded in dismissing negligence claims without prejudice and battery claims with prejudice, but failed to dismiss nuisance claims.  Id. at **26-40.

That brings us to severance, which the court raised sua sponte while the motions to dismiss were pending.  The plaintiff opposed severance, the earlier defendant took no position, and the later defendant favored severance.  Severance is decided based on the factors for joinder under Rule 20—the same transaction(s) or occurrence(s) and common questions of law or fact—plus “whether settlement or judicial economy would be promoted, whether prejudice would be averted by severance, and whether different witnesses and documentary proof are required for separate claims.”  Id. at *41.  Without deciding whether joinder was appropriate under Rule 20, the court found that each factor favored severing the case into fourteen separate cases with one plaintiff each.

First, differences in “the timing and length of each plaintiff’s alleged exposure to EtO” meant different questions about emissions from the plant, which defendant was responsible, and what they knew when.  “The distinct periods of exposure will also bear on each plaintiff’s showing of fault and causation, thereby affecting the legal viability of each plaintiff’s case.”  Id. at *43.  Second, the plaintiffs lived different distances from the plant and had different work and life patterns.  This meant questions of their exposure to EtO from the plant and exposures to “other toxins and risk factors” would differ.  Id.  Third, the analysis of whether claims were time-barred varied by plaintiff and would need to be resolved later.  Id. at **43-44.  Fourth, the evidence on causation and damages would vary significantly from case to case, especially because multiple different cancers were at issue.  Id. at **45-46.  “The highly individualized nature of these medical inquiries further persuades this Court that severance is proper.”  Id. at *46.

Last, and perhaps most important from our perspective, is this prescient statement:

[T]hese cases are clearly destined for separate trials.  Trying all fourteen cases to the same jury would be unduly prejudicial to defendants, and would pose an unacceptable risk of confusing the jury.  For instance, as one court has explained, “by trying . . . two [plaintiffs’] claims together, one plaintiff, despite a weaker case of causation, could benefit merely through association with the stronger plaintiff’s case.”  And because separate trials are inevitable, the Court finds [it is] appropriate to sever the cases at this stage, before the start of discovery.

Id. at **46-47 (internal citation omitted).  Our perspective, of course, is shaped by representing drug and device companies in serial product liability litigation.  It should be apparent how the first four factors above will typically favor severing cases with multiple plaintiffs bringing product liability claims against the makers of prescription medical products, especially if “exposure” is translated to “dose and duration” of use in a drug case.  While severance is important, particularly in the context of addressing misjoinder of parties to defeat diversity, multi-plaintiff trials are probably more of a problem these days.  With the explosion of MDLs and other coordinated proceedings, the plaintiffs and some judges often suggest that such trials are necessary to work through the case, provide information for settlement evaluation, etc.  Even non-MDL federal district courts receiving a number of cases transferred from an MDL may feel compelled to go this route.  The Ellis court was right to spot that the inevitable confusion and likely bootstrapping that go on with multi-plaintiff trials tend to be prejudicial to the defendants.  The more plaintiffs and greater differences there are between their claims, the greater the risk of prejudice to the defendants.  Absent very unusual circumstances, considerations of efficiency for the court or deference to how the plaintiffs chose to proceed as a pack should not be convincing reasons for multi-plaintiff trials.

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Particularly in economic loss class actions, we occasionally have to deal with claims involving the Magnuson Moss Warranty Act (“MMWA”).  Thus, we have covered MMWA issues before.  Here’s another one.  In In Re Hill’s Pet Nutrition, Inc., Dog Food Products Liability Litigation, 2022 WL 1641291 (D. Kan. May 24, 2022), the court held that foreign plaintiffs that bought goods exported from the United States in foreign countries cannot bring MMWA claims because the statute cannot be applied in an extraterritorial fashion.  Given the paucity of prior precedent in the Hill’s Pet decision, we thought it was worth bringing this to the attention of our readers.

The plaintiff in Hill’s Pet was “a resident of Germany who bought recalled . . . pet food and fed it to her dog.”  Id. at *1.  That plaintiff sought to bring “a class action on behalf of other European purchasers of recalled” product.  Id.  The defendants sought, and received, dismissal on the ground that the MMWA cannot apply extraterritorially to overseas purchases of consumer goods in foreign countries.

There is not much precedent on the extraterritoriality of the MMWA.  The Sixth Circuit, in a device case that earned an honorable mention in our 2020 Best Cases post for other reasons, identified the extraterritorial issue, but did not decide it.  In re DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation, 953 F.3d 890, 896 (6th Cir. 2020).  District courts had split, with MY. P.I.I., LLC v. Tognum America, Inc., 2016 WL 7626201, at *3-6 (S.D. Fla. March 31, 2016), Stein v. Marquis Yachts, LLC, 2015 WL 3440163, at *2-3 (S.D. Fla. 2015), and In re Toyota Motor Corp., 785 F. Supp.2d 883, 914 (C.D. Cal. 2011), all holding that the MMRA had no extraterritorial effect.  On the other hand, Barnext Offshore Ltd. v. Ferretti Group USA, Inc., 2011 WL 13223746 (S.D. Fla. May 16, 2011), applied the MMWA extraterritorially, but only where the plaintiff was a United States citizen who had bought a product overseas with the intent of using it in the United States.  Id. at *5-6.

Hill’s Pet went with the majority rule, for several reasons:

  • There is a “presumption against extraterritoriality” that applies to all federal statutes, reflecting “commonsense notion that Congress generally legislates with domestic concerns in mind.” 2022 WL 1641291, at *3 (footnote and quotation marks omitted).
  • In enacting the MMWA, Congress gave no “clear, affirmative indication that it applies extraterritorially.” at *3-4 (footnote and quotation marks omitted).
  • Similarly worded statutes had been interpreted not to apply extraterritorially. at *4.
  • The Federal Trade Commission, which enforces the MMWA, “has similarly interpreted the MMWA not to reach exported consumer products sold abroad” and “does not contemplate the enforcement of the Act with respect to consumer products exported to foreign jurisdictions.” at *5 (footnotes and quotation marks omitted).
  • The MMWA had no conceivable “domestic application,” since “the alleged sales of [the] products all took place in Europe, not the United States.” at *6.

Another bogus class action bites the dust, while providing useful precedent that should help deter repetition of such meritless litigation.

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We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., Inc. v. IntegraDose Compounding Servs., LLC, 2022 Minn. Dist. LEXIS 1734 (Minn. 4th Dist. May 24, 2022), is unusual. It is not a product liability case. Rather, a pharmaceutical company sued a compounder for fraudulently stealing business from it. The plaintiff manufactured an ephedrine sulfate solution used to control blood pressure in surgical patients. The unique benefit of the plaintiff’s ephedrine solution was its 5 mg/ml concentration. It did not need to be diluted from the standard 50 mg/ml concentration. The FDA approved the plaintiff’s 5 mg solution, and the only other FDA approved ephedrine solutions came in the 50 mg concentration.

But along came the defendant large-scale compounder, which started prefilling syringes with a 5 mg solution that had been diluted from 50 mg. It was not FDA approved. The plaintiff cried foul, claiming that the defendant had copied its product, violated Minnesota law regulating pharmaceutical compounding, and defrauded customers. The defendant moved to dismiss the case.

The Nexus court held that the Minnesota Pharmacy Act, which formed the basis of the plaintiff’s lawsuit, was inapplicable. It governed compounding practices by pharmacies, but did not deal at all with large-scale outsourcing compounding facilities such as the defendant. The plaintiff groused that it was improbable that Minnesota would not regulate outsourcing facilities. Not so, said the Nexus court, because “any such facility would be duly regulated under the FDCA, and the Minnesota Legislature’s decision to forego regulation of federal outsourcing facilities is not unusual.”

And that gets us to federal preemption. The Nexus court went on to hold that even if there was a claim under the Minnesota statute, such claim would be impliedly preempted. Minnesota courts have held that to avoid being preempted by Buckman, a claim “must rely on traditional state law which had predated the federal enactments in question.” That didn’t happen here. Instead, all of the plaintiff’s claims “exist solely by virtue of the FDCA requirements.” The only way for the court to consider the claim would be to look at the FDCA, from which the Minnesota legislature had copied terms in its state legislation.

The plaintiff in Nexus trotted out the presumption against preemption. The Nexus court entertained no such presumption, quoting Buckman to the effect that “[when] the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originated from, is governed by, and terminates according to federal law … no presumption against preemption obtains.”

The Nexus court found multiple bases to pour out the plaintiff’s claims. (Multiple, alternate bases for ruling against a party can make an appeal look much less appetizing.) The plaintiff’s fraud claims flunked the particularity test. The complaint alleged “no facts suggesting Defendant IntegraDose intended to deceive purchasers, and no facts regarding who, if anyone, saw or relied on the statements on IntegraDose’s website or when they were seen.” Further, the statements on the website were general and not specific to the product at issue.

But wait, there’s more. Some of the plaintiff’s state law consumer deception claims amounted to private attorney general actions. To bring such claims under Minnesota law, the plaintiff must demonstrate that its cause of action benefits the public. Here, the complaint did not lay out any harm to the public. On the contrary, the harm seems to have been visited upon the plaintiff itself (its sales and reputation). The Nexus court saw the case as a beef about harm to a competitor, not a harm to competition or to consumers. (That is why there is a Lanham Act.) This discussion reminds us of the central point in our Antitrust class at the University of Chicago Law School almost 40 years ago: the problem is harm to consumers, not competitors. We recognize that there are now plenty of people pushing back against the Chicago School consumer welfare theory of antitrust law, but we’re sticking with it. It is one of the three or four things we remember from Law School. (Other tidbits stuck in our brain pan include the Rule in Shelley’s Case and the distinction between larceny by trick and taking under false pretenses. Bexis asked us about the rule against perpetuities. Yes, we remember that, too, but more from the movie Body Heat than from our Property or Trusts & Estates classes.) Don’t try teaching this old dog new tricks. We’re likely to bite you or piddle on the rug.

The Nexus court granted the plaintiff’s motion to dismiss with prejudice. But as if to give the hapless plaintiff an extra kick in the rear as it was being hustled out the courtroom door, the Nexus court reasoned that the plaintiff’s claim that the defendant had impermissibly copied its product turned on matters placed within the special competence of the FDA. Thus, even if any of the plaintiff’s causes of action could somehow survive, dismissal without prejudice would be appropriate pursuant to the doctrine of primary jurisdiction.

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We DDL bloggers frequently grouse about other lawyers, but, in truth, most of our favorite people are lawyers. More often than not, they are smart, kind, and funny.

This week saw the passing of one of the smartest, kindest, and funniest, our good friend Irv Hurwitz. Irv devoted his efforts to raising money for nonprofits. That is completely characteristic of his generosity and public spiritedness.

We are so grateful to have known Irv. How lucky for us that when we (reluctantly) moved to Philly from LA 25 years ago, Irv was our next door neighbor. We had a lot in common besides a boundary. We both had two kids — a girl and a boy. Our birthdays were only two weeks apart. We were almost exactly the same height. We literally and figuratively saw things eye to eye. We used to ride the morning train in together, chatting about work, current affairs, family, and the Phillies.

We are so grateful that we got the chance to say goodbye. We are so grateful we told Irv how much he meant to us. Irv recalled one splendid day we spent together, driving out to Pottsville to tour the Yuengling beer factory (where we met Dick Yuengling and thanked him for brewing such a swell lager), viewed a beautiful valley from a pagoda perched on top of Mount Penn (thanking whoever had the crazy idea of placing a pagoda in Reading), and attended a Reading Phillies game (where we ran into Charlie Manuel, who had managed the Philadelphia Phillies to a world championship. We incoherently and repeatedly showered Charlie with thanks). Irv was always prompting feelings of gratitude.

We are so grateful that, amidst convulsions of sorrow, we managed to hug and thank Irv for being such a good friend and seeing us through some tough personal times. He was the sweetest and loveliest man. He was a mensch. He brought us so much joy and wisdom over the last quarter of a century.

Some day we will tally the tears and know they were greatly outnumbered by all the laughs Irv shared with us. But not today.

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Given what we saw in states such as Mississippi, Oklahoma, and Idaho even before the Supreme Court’s  in Dobbs v. Jackson Women’s Health Org., ___ S. Ct. ___, 2022 WL 2276808 (U.S. June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means.  At least one state already has such a law.  La. R.S. §40:962.2.

States can exercise control (for good or ill) over medical practice, including the prohibition of illegal drugs.  Whalen v. Roe, 429 U.S. 589, 597 (1977); Robinson v. California, 370 U.S. 660, 664 (1962).  But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications.  In enacting the FDCA, Congress created the FDA and charged it with “promot[ing] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.”  21 U.S.C. §393(b)(1).  Congress required the FDA to “protect the public health” by making sure that “drugs are safe and effective.”  Id. §393(b)(2)(B).

“Pre-emption is not a matter of semantics.  A State may not evade the pre-emptive force of federal law by resorting to . . . description at odds with the statute’s intended operation and effect.”  Wos v. E.M.A. ex rel. Johnson, 568 U.S. 627, 636 (2013).  On occasion, states have attempted to prohibit sale and/or use of non-abortion-related FDA-approved products, but with one exception, these efforts have not resulted in litigation.  See Lars Noah, “State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products,” 2016 Mich. St. L. Rev. 1, 16-22 (2016) (collecting examples).

However, one state’s attempt to prohibit doctors in that state from prescribing an FDA-approved opioid did produce interesting precedent (which we previously discussed here and here).  Massachusetts was enjoined in Zogenix, Inc. v. Patrick, 2014 WL 1454696 (D. Mass. April 15, 2014) (“Zogenix I”), and Zogenix, Inc. v. Patrick, 2014 WL 3339610 (D. Mass. July 8, 2014) (“Zogenix II”), vacated in part on other grounds, 2014 WL 4273251 (D. Mass. Aug. 28, 2014) (after prohibition rescinded) (“Zogenix III”).  The state (technically, a commonwealth) first tried an outright ban − allowing only an “abuse-resistant formulation” that the FDA had not approved − with the governor “empower[ing]” the public health department “to immediately prohibit the prescribing and dispensing of” the plaintiff manufacturer’s drug.  Zogenix I, 2014 WL 1454696, at *1-2.  The ban was preempted.  “If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health.”  Id. at *2

The state then took another tack, enacting onerous “regulations limiting the prescribing and handling of” the drug that amounted to a “de facto ban.”  Zogenix II, 2014 WL 3339610, at *1, 3.  The disputed regulations ostensibly regulated how health care providers and pharmacists could prescribe and/or dispense the targeted drug.  They required that the prescriber “certify” in a particular for of writing that “other pain management treatments have failed” and they limited its distribution “only” to pharmacists.  Id. at *2.  The plaintiff manufacturer argued, and the court agreed, that the state’s regulations were so restrictive that they effectively “banned [the drug’s] prescribing, ordering, dispensing, or administration.”  Id. at *1.

Logically, that state action contradicted the FDA’s determination, essential to the FDA’s approval of that (or practically any) product, that the drug’s benefits outweighed its risks.  The state could not interpose its “no,” where the FDA, exercising federal power, had said “yes.”  This logical contradiction posed a significant “obstacle” to the exercise of the FDA’s authority to approve the products it regulates for marketing.  “What is a sufficient obstacle is a matter of judgment, to be informed by examining the federal statute as a whole and identifying its purpose and intended effects.”  Id. at *2 (quoting Crosby v. National Foreign Trade Council, 530 U.S. 363, 373 (2000)).  The effective state-law ban of an FDA-approved drug necessarily “frustrated” the FDCA’s statutory scheme, requiring that the state’s power “must yield to the regulation of Congress.”  Zogenix II, 2014 WL 4273251, at *2 (quoting Savage v. Jones, 225 U.S. 501, 533 (1912)).

  • “to ‘protect the public health’ by ensuring that ‘drugs are safe and effective’”;
  • to require that “[t]he FDA must approve new drugs before they are introduced to the market”;
  • to create “a structured risk-benefit assessment framework” administered by the FDA;
  • to preclude approval of any new drug “if [the FDA] concludes the drug is unsafe, or if there is insufficient information from which to determine whether the drug is safe”; and
  • to “mak[e] available to the public” new drugs that “pass[] the [FDA’s] benefit-risk assessment” and thus “promote[] the public health.”

Id. at *3 (various statutory citations omitted).

The state continued to run afoul of preemption in Zogenix II by “trying to make scarce or altogether unavailable a drug that the FDA, by approving it, has said should be available.”  Id.  Notwithstanding a state’s undisputed police power “to regulate the administration of drugs by the health professions,” no state may “exercise those powers in a way that is inconsistent with federal law.”  Id. at *5.  While states had considerable power to regulate the use of opioids as controlled substances, they could not exercise that power to bar the use of an FDA approved drug altogether through the chilling effect of what Zogenix II found to be a “vague” and “uncertain” regulatory scheme.  The state “Defendants may interpret and enforce the challenged regulations in a way that obstructs the FDCA’s objectives,” however, they may also act more liberally.  Id. at *5.

Finally, in Zogenix III, after the state rescinded that set of regulations and “promulgated new regulations” that “omit[ted] the conflicting, troublesome language” that amounted to a ban by other means, the new regulations “no longer offend[ed] the Supremacy Clause of the United States Constitution.”  2014 WL 4273251, at *1, 3.  “The obstacle − mandatory preliminary prescribing of other [drugs] − has now been removed.”  Id. at *3.

While the Zogenix litigation invoked so-called “purposes and objectives” preemption (see our discussion here), additional support for preemption of state-law bans of FDA-approved drugs under the rubric of impossibility preemption is found in product liability decisions that are the Blog’s primary focus.  An absolute prohibition on the marketing of an FDA-approved product is the most extreme form of a purported state-law “stop selling” duty that the United States Supreme Court held preempted in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  “Stop-selling” claims are simply:

incompatible with our pre-emption jurisprudence.  Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether…. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless.

Id. at 488 (citation and quotation marks omitted).  Importantly, Bartlett recognized that “statutory ‘mandate[s]’ do precisely the same thing” as tort suits in that they “require a manufacturer to choose between leaving the market and accepting the consequences of its actions.”  Id. at 491.  Bartlett went on to analogize imposition of stop-selling tort liability to a state’s “directly prohibiting the product’s sale.”  Id. at 489 n.5.  Even one of the two dissents in Bartlett expressed discomfort with stop selling claims.

The FDA is responsible for administering the relevant federal statutes.  And the question of pre-emption may call for considerable drug-related expertise.  Indeed, one might infer that, the more medically valuable the drug, the less likely Congress intended to permit a State to drive it from the marketplace.

Id. at 494 (but finding conflicting FDA positions on the particular issue before the Court) (Breyer & Kagan JJ., dissenting).

Thus, “‘an outright ban’ cannot be a viable alternative to sustain a [state-law] claim.”  Trisvan v. Heyman, 305 F. Supp.3d 381, 405 (E.D.N.Y. 2018).  “Insofar as the plaintiffs’ . . . suggest[] that the defendants should never have sold the FDA-approved formulation of [their drug], such claims have been explicitly repudiated by the Supreme Court.”  Utts v. Bristol-Myers Squibb Co., 226 F. Supp.3d 166, 186 (S.D.N.Y. 2016).  Likewise, in Silver v. Bayer Healthcare Pharmaceuticals, Inc., 2021 WL 4472857 (D.S.C. Sept. 30, 2021), the plaintiff’s claim that the defendant’s drug “should have been banned . . . constitutes a ‘stop-selling’ theory, which courts have consistently found to be preempted by federal law.”  Id. at *4.

Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), similarly preempted a state-law claim “that defendants should never have sold the[ir] FDA-approved [product] in the first place” was preempted under Bartlett as another variant of a “‘stop-selling’ rationale.”  Id. at 300.  Similarly reflecting Bartlett’s holding, preemption of demands based on state law that drug/device manufacturers refrain from selling their FDA-approved products is widespread.  The court in Gross v. Pfizer, Inc., 825 F. Supp.2d 654 (D. Md. 2011), aff’d, 741 F.3d 470 (4th Cir. 2014), was “aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce.”  Id. at 659.  “Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.”  Id.  Likewise, an appellate court in California “conclude[d] that plaintiff’s design defect claim that defendants should have withdrawn [the drug] from the market is preempted by the impossibility preemption analysis . . . in Bartlett.”  Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127, 158 (Cal. App. 2017).

In Mayor & City Council of Baltimore v. GlaxoSmithKline, LLC, 2022 WL 537004 (Md. Cir. Jan. 28, 2022), a municipality sought to prohibit the marketing of an entire class of drugs because they were allegedly “inherently dangerous even when taken as directed and when appropriately stored.”  Id. at *4.  That claim was “impliedly preempted” because it was grounded on the contention that the defendants “would violate their duty under [state] law by simply marketing [their drugs] in its FDA-approved form and with its FDA-approved label.  In other words, they would have been required to stop selling” their products.  Id.

Numerous other courts reject allegations that state law can prohibit the sale of FDA-approved drugs.  Evans v. Gilead Sciences, Inc., 2020 WL 5189995, at *9-10 (D. Haw. Aug. 31, 2020) (quoting and following Bartlett); Javens v. GE Healthcare, Inc., 2020 WL 2783581, at *6 (Mag. D. Del. May 29, 2020) (claim that defendants should have marketed a different product was “clearly preempted by federal law), adopted, 2020 WL 7051642 (D. Del. June 18, 2020); Mahnke v. Bayer Corp., 2019 WL 8621437 at *5 (C.D. Cal. Dec. 10, 2019) (quoting and following Bartlett); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761, 771 (D.S.C. 2016) (“any claims that Defendant should have simply stopped selling the drug to women . . . is preempted”); Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 678 (S.D.N.Y. 2017) (claims that “challenge[] the FDA’s approval of . . . [an] indication . . . are preempted”) (quoting 73 Fed. Reg. 49603, 49606 (FDA Aug. 22, 2008)), aff’d, 919 F.3d 699 (2d Cir. 2019); In re Fosamax Products Liability Litigation, 965 F. Supp.2d 413, 420 (S.D.N.Y. 2013) (Bartlett “preempted the possibility of [state law] claims based on a [drug manufacturer’s] failure to stop selling the product”).  But see Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528, 537-38 (6th Cir. 1993) (pre-Bartlett decision allowing what was essentially a stop selling claim) (applying Kentucky law).

A couple of other cases we’ve blogged about also bear on state-law attempts to ban FDA-approved products.  First, in a non-product liability application of Bartlett, the court in Exela Pharma Sciences, LLC v. Sandoz, Inc., 486 F. Supp.3d 1001 (W.D.N.C. 2020), held that a competitor could not attack the FDA’s discretion to allow a product on the market on an emergency basis through a “memorandum of discretion.”  Id. at 1008.  The Excela decision analogized the plaintiff’s attack on the legality of the defendant’s FDA-approved importation of its product to a Bartlett-style “stop-selling” claim:

[T]he FDA issued a Memorandum . . . allowing the Defendant temporary permission to import and sell its [drug] product.  Notwithstanding the Defendant’s permission from the FDA, a viable [trade practices] claim related to the import and sale of [that] product would have nonetheless forced the Defendant “to leave the market or accept tort liability.”  This is precisely the type of claim that . . . must be preempted.

Id. at 1015 (quoting Drager v. PLIVA USA, Inc., 741 F.3d 470, 479 (4th Cir. 2014)).  Consequently, any claim “assert[ing] that the only way to comply with state law would have been for the Defendant to leave the market notwithstanding the Defendant’s compliance with the FDA’s directives” is preempted.  Id.

Finally, for historic reasons we discussed here, the FDA, for a long time (this now seems to be changing) allowed the marketing and sale of homeopathic products despite considerable questions about their efficacy.  In 2015, private plaintiffs, wielding state-law causes of action, attempted to enjoin the continued sale of homeopathic products market despite the FDA allowing them to be sold.  Herazo v. Whole Foods Market, Inc., 2015 WL 4514510 (S.D. Fla. July 24, 2015).  That injunctive claim was impliedly preempted.

Plaintiffs’ suit seeking to change the labeling requirements of Defendant’s homeopathic medication conflicts with federal policy and should be impliedly preempted. . . .  [T]he Court additionally finds that allowing the claim for injunctive relief to go forward would undermine the purpose for which Congress enacted the uniformity provision and thwart the Food and Drug Administration’s ability to carry out its oversight of marketing of homeopathic products.

Id. at *5.

As our past posts indicate, we’ve always been interested in the preemption of state-law “stop selling” claims.  But before, that had been in our capacity as defense counsel in prescription medical product liability litigation.  Post-Dobbs, it’s personal as well.  Because, as this post makes crystal clear, FDCA-based preemption can be a pro-choice position.

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

Before we get to today’s case, we fondly tip our hat to the Westminster Kennel Club Dog Show, held (and televised) last week.  Regular readers know how much we love this annual event and also may recall that our “heart breed” is the Standard Poodle.  (We actually had a probable future family member competing – “Joel,” a gorgeous grand champion white standard shown in cords.) Ultimately, the purple Best in Show Rosette was awarded to Trumpet the Bloodhound, marking the first time that breed has taken the top honor at Westminster.  By all accounts, Trumpet is a spectacular representative of his venerable breed, and we are excited about his historic win.

We also are happy about the result in today’s case, Africano v. Atrium Med. Corp., 2022 U.S. Dist. LEXIS 100428 (N.D. Ill. June 6, 2022), in which the court denied the plaintiff’s motion for new trial and affirmed multiple helpful rulings on the admissibility and inadmissibility of FDA-related evidence.  We have blogged about Africano three times before.  The plaintiff asserted claims for failure to warn and manufacturing defect, alleging that the defendant’s allegedly unsterile hernia mesh injured him when it was implanted in him to repair his inguinal hernia.  At trial, as we reported, the jury found for the defendant on both claims.

The plaintiff moved for a new trial pursuant to Fed. R. Civ. P. 59, arguing that the trial court erred in excluding several pieces of evidence.  First, the plaintiff argued that the court should have admitted evidence of a government complaint and consent decree against the defendant.  The consent decree shut down one of the defendant’s manufacturing plants until the defendant came into compliance with certain FDCA manufacturing regulations.  Before trial, the court granted the defendant’s motion in limine to exclude both documents, holding that “both constituted inadmissible hearsay; that the complaint did not fall under the public records exception to hearsay; that the consent decree did not constitute non-hearsay evidence as a statement of a party opponent; and that [Fed R. Evid.] 408 also rendered the consent decree inadmissible to the extent [that the plaintiff] offered it to prove the truth of the matters contained therein.”  Africano, 2022 U.S. Dist. LEXIS 100428 at *4-5 (citation omitted).

On the eve of trial, the plaintiff moved for reconsideration of the exclusion of the FDA complaint, arguing that it intended “to use the complaint for the non-hearsay purpose of impeaching [the defendant’s] argument” that it had cured deficiencies in its sterilization process.  The court denied the motion, finding that the complaint did not address the sterilization process in question but “broadly alleged regulatory violations that were not facially related to the” sterilization process,   id. at *5, so could not be used be used for impeachment as the plaintiff described.  The court also found that the complaint was inadmissible under Rules 401 and 403 because it related to an inspection that postdated the manufacture of the plaintiff’s hernia mesh, so “the risk of prejudice and confusion outweighed the complaint’s limited probative value.”  Id. at *6 (citation omitted).

In his motion for a new trial, the plaintiff argued that the complaint was not hearsay because the plaintiff “would not have offered it to prove that the [sterilization process] was not adequate, only that the FDA had not found that it was.”  Id. at *7 (citation omitted).  The court held:

This argument, as Defendant points out, is pure sophistry.  The only relevance of the FDA’s view of a process being inadequate is to show that the process actually is inadequate.  Plaintiff therefore sought to admit the complaint for the truth of the matters purportedly asserted therein – that Defendant’s sterilization validation was inadequate.  This runs headlong into the rule against hearsay.

Id., at *7-8.   Moreover, contrary to the plaintiff’s argument that the complaint was relevant because it suggested that the defendant’s validation of its sterilization process was not adequate, the court reiterated that the complaint “did not say anything about whether the sterilization validation was inadequate.”  Rather, it alleged “broad regulatory violations that, on their face, [did] not specifically related to the sterilization validation process that concerned” the plaintiff’s hernia mesh product.  Id. at *8.   Finally, the complaint did not qualify for the public records exception to the hearsay rule because it contained “mere allegations, not factual findings.”  Id. 

The plaintiff also argued that the court erred in excluding two observations from an FDA Warning Letter the defendant received.  The court had allowed the plaintiff to introduce the first page of the warning letter and the first of six observations, which, it found, was relevant to the case because it addressed the adequacy of the defendant’s validation of its sterilization process.  In his motion for a new trial, the plaintiff challenged the exclusion of the second and third observations.  Observation 2 concerned a different mesh than the mesh implanted in the plaintiff, and Observation 3 concerned foreign material, including hair, found in the defendant’s sterile medical devices.  The court found that the plaintiff had not met his burden of showing that these incidents “occurred under substantially similar circumstances [to] those at issue in this case;” thus, he “failed to show the probative value of these other incidents.”  Id. at *11 (citation omitted).   As such, “the potential for these unrelated incidents to confuse and mislead the jury substantially outweighed their probative value.”  Id.

The court also rejected the plaintiff’s argument that the court’s exclusion of Observations 2 and 3 “prevented the jury from considering the entirety” of the defendant’s failure to “address basic contamination prevention.”  Id. (internal punctuation and citation omitted).   To the contrary, the court emphasized, the jury was permitted to see the unredacted first page of the warning letter, which set forth the defendant’s failure to conform to the relevant regulatory requirements.  Finally, the court rejected the plaintiff’s argument that the exclusion of Observations 2 and 3 impaired his ability to cross-examine the defendant’s experts, emphasizing, again, that the excluded observations concerned observations “having nothing to do with the sterilization procedures relating to the . . . mesh product” at issue in the case.   The court concluded,

After considering [Plaintiff’s] arguments, this Court determines a new trial is unwarranted.   Plaintiff has not demonstrated that any of this Court’s evidentiary decisions constitutes error, much less the kind of error that had a substantial and injurious effect on the jury’s verdict.  Accordingly, this Court denies Plaintiff’s motion for a new trial.

Id. at *15 (citation omitted).   We really like this opinion.   Complicated evidentiary issues like these are a quagmire, and it is too easy for courts to punt tough threshold admissibility questions in favor of juries’ “weight of the evidence” assessments.   We agree with the court’s pretrial rulings and applaud its refusal to reconsider them.

We’ll talk to you soon, hopefully with poodle news to share.  In the meantime, stay safe out there.

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Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues.  Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon.  Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility.  Id. at *1.

The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  It wasn’t.  Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.”  Id. at *2.  Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 

Continue Reading FDCA-Based Negligence Per Se & Informed Consent Don’t Mix

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