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Even though lawyers who bill for their time defending product liability cases might favor those cases sticking around and plaintiffs getting many chances before inevitable dismissals with prejudice, we have been clear that we think plaintiffs should not get to re-plead around preemption once courts have defined the preempted path.  There seems to be an unwritten three strike rule when it comes to complaints, meaning it is often not until a second amended complaint that asserted claims are dismissed with prejudice in response to 12(b)(6) motions. See here, here, and here.  When it comes to motions to dismiss on preemption—which is a way in which a plaintiff can fail to state a viable claim—one strike should usually be enough unless the plaintiff avails herself of Fed. R. Civ. P. 15(a)(1)(B) or a state equivalent to put in an amended complaint in response to a motion to dismiss.  Given the availability of the opportunity to amend a complaint as of right, the first time a court dismisses claims as preempted the dismissal should be with prejudice.

Almost nineteen months ago, we detailed a pretty good decision finding all the product liability claims asserted as to a prescription drug to be preempted, although only some of the claims were dismissed with prejudice.  It should not have taken much more time for plaintiff to try and fail to re-plead non-preempted claims.  Yet, plaintiff here got the leeway a plaintiff often gets and it ultimately took more than thirty-three months from filing for the defendants to get a complete dismissal with prejudice.  Brashear v. Pacira Pharms., Inc., No. 1:21-cv-700, 2024 WL 380465 (S.D. Ohio Aug. 19, 2024).  We say defendants because plaintiff served two additional related entities after the manufacturer largely won its first motion to dismiss.  Those additional defendants offered a range of grounds for dismissal, but we will focus on preemption.  After its original order, the court also granted plaintiff’s motion to change the dismissal of one of the claims from with prejudice to without prejudice.  Then the plaintiff missed her deadline to file an amended complaint, which ended up being largely a re-hash of her prior complaint.

Ultimately, three asserted claims were at issue in Brashear II.  Plaintiff alleged that the drug’s label was inadequate because it was not changed after approval to add a warning about a purported risk of injury to the diaphragm.  Consistent with the refreshing change in the drug product liability litigation landscape from Levine to Albrecht, the court stated “most failure-to-warn claims are preempted because drug labeling is highly federally regulated.”  2024 WL 380465, *5.  As before, plaintiff could not base a claim on the defendants’ alleged failure to seek approval for a labeling change because such a claim would be based on an obligation that exists only because of the FDCA.  Id.  It would also run afoul of the independence principle from Mensing because the court cannot presume that FDA would have approved the labeling change if requested.  Plaintiff also got a chance to articulate why defendants should have utilized a CBE to make a labeling change based on new information of a risk, but her amended complaint did not come close:

Despite claiming in an earlier filing that she could provide new allegations to that effect, Brashear has pointed to no facts that plausibly suggest such new information exists.

Id. at *6 (emphasis in original and internal citation omitted).  Although not mentioned in the amended complaint, plaintiff tried to point to a case report involving one patient who took a different drug.  Not only could this “evidence” not in the pleadings not be considered at this stage—it was certainly not judicial notice material—it “does not permit of a plausible inference that such a paper constitutes newly acquired information serving as evidence establishing a causal link between the drug in question and the alleged risk of harm.”  Id. at *6 & n.8 (emphasis in original).  That meant dismissal of the warnings claim with prejudice as to all the defendants.

Next up was a “false marketing claim,” which was really an attempt to assert a failure to warn claim based on something other than the content of the label.  Despite Brashear I making it clear that the alleged misrepresentation had to be outside the label to have a chance at not being preempted, plaintiff “cites only representations Defendants made on Exparel’s label as the basis for her claims that she was misled into believing that the drug was safe and effective for pain management.”  Id. at *6.  Dismissal with prejudice on that one too (but no costs for wasting everyone’s time).  Given the drug’s approved indications—that is, the local and regional analgesic uses for which FDA has determined the drug is safe and effective—plaintiff would have had to have some extra-label false promise of efficacy for an off-label use.

Last was a “supplier liability claim.”  Again, this was really a slightly re-packaged design defect claim, which the manufacturer had already gotten dismissed with prejudice in Brashear I.  The court saw this particular formulation as a “stop-selling” claim preempted by Bartlett.

As Brashear fails even to address the preemption issue latent in this stop-selling argument, the Court adheres to its previous determination that Brashear may not challenge the “dangerousness” of Exparel to maintain her supplier liability claim.

Id. at *6 (internal citation omitted).  Another dismissal with prejudice (but no costs for wasting everyone’s time).

If we have been too subtle—a rarity, for sure—we think there should be some penalty to deter this kind of litigating by the plaintiff.  When a plaintiff takes a voluntary dismissal and re-files, Fed. R. Civ. P. 41(d) authorizes the court to “order the plaintiff to pay all or part of the costs of that previous action” and “stay the proceedings until the plaintiff has complied.”  Maybe amending complaints in response to 12(b)(6) motions or orders on 12(b)(6) motions should involve the same dynamic, with the Rules specifically authorizing courts to impose a sort of user fee from the plaintiff if she insists on taking another swing.

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We’ve all heard that “what’s good for the goose is good for the gander.” Some of us describe it as “the rule of poultry equivalents.” However you phrase it, we’ve always thought that if a defendant’s insurance is routinely discoverable, a plaintiff’s litigation financing agreement should be as well. Today’s decision from Delaware, Burkhart v. Genworth Financial, Inc., 2024 WL 3888109 (Del. Ch. Aug. 21, 2024), isn’t a pharmaceutical or medical device case, but it is the fourth decision out of the Delaware state courts holding that a plaintiff’s litigation funding agreement is discoverable.  The decision adds to some of the positive case law and local rules related to litigation funding that we’ve addressed here, here and here.  

Continue Reading Litigation Funding Agreements Discoverable in Delaware
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In re Hair Relaxer Mkt. Practices & Prods. Liab. Litig., 2024 U.S. Dist. LEXIS 150916 (N.D. Illinois Aug. 22, 2024), is a fairly interesting decision on MDL procedure.  We say “fairly” because the case is mostly a matter of voyeurism for defense hacks. The case is about how lead plaintiff counsel get paid.  Nobody – not the courts and certainly not the plaintiff counsel – asks for the defense opinion on such things.  

And we’re not sure we have much of an opinion. But maybe we should.  Someday, someone should do a game theory analysis about how allocation of moneys among plaintiff lawyers in MDLs affect things such as the initiation, size, and cost of MDL litigation.  In the meantime, and just before scrolling through the Hair Relaxer opinion, we grabbed a bag of popcorn and watched the plaintiff lawyers squabble among themselves.   

The Plaintiffs’ Co-Lead Counsel, Plaintiffs’ Executive Committee, and Plaintiffs’ Steering Committee (these titans of the law were collectively referred to as the PLC)  sought to have the MDL court impose a “common benefit fee” holdback not only on cases that were in the MDL but also on similar cases “in state court or that are settled before filing in any court.”  

Only one plaintiff firm objected to this request.  Usually, the plaintiff firms objecting to PLC requests are bottom feeders. Not here.  The objecting plaintiff firm is a really good firm with really smart lawyers.  How smart? You do not need to read the sparkling website bios (Supreme Court clerkships, etc.) to answer that question   All you have to do is read the Hair Relaxer opinion to see how the objecting firm correctly made the point that an MDL court cannot allocate moneys from cases not in the MDL. 

The PLC did not go down without a fight.  They (it?) argued that the MDL court was empowered to impose holdbacks under at least three separate sources of judicial authority: (1) the equitable common benefit doctrine; (2) the court’s inherent managerial power over consolidated litigation; and (3) private contracts.  But the MDL court did not buy any of these arguments.  It held that it did not have any basis for exercising jurisdiction over non-MDL cases.  

Equitable Common Benefit Doctrine

The common fund doctrine is an exception to the American rule whereby everyone pays their own attorney’s fees.  The idea of a common benefit fund in aggregated litigation is to address the situation where “the plaintiff’s successful litigation confers a substantial benefit on the members of an ascertainable class, and where the court’s jurisdiction over the subject matter of the suit makes possible an award that will operate to spread the costs proportionately among them.”  

Did you catch that bit about the court’s jurisdiction?  The Hair Relaxer decision makes clear that, whatever the equitable benefits of the common benefit fund doctrine, it cannot confer “unbridled jurisdiction” on the MDL court.  

The PLC whined that a common benefit fund is necessary to prevent “free riding” by their indolent plaintiff side colleagues.  We like how the court characterizes this argument: “indeed, the PLC portends the day when MDL courts will be unable to attract any counsel without assurances of adequate compensation and protection against free riders.”  At this point, we find ourselves quoting the great Brian Wilson — “Wouldn’t it Be Nice.”  And then we like even better how the court rejects the plaintiff’s argument: “As this MDL evidences, that day has not come.”  Ha. Look, if there really is a “free rider” problem, it is the PLC’s problem, not the court’s, since that sort of (non) problem is no basis for expanding jurisdiction.  

Inherent Managerial Power

Just like any district court, an MDL court undoubtedly has inherent managerial power over its docket. (It is a profound pity how some MDL courts decide that the best management strategy is to do nothing and wait out the parties until they settle.  But we digress.) in any event, managing an MDL docket is limited to the cases actually in that docket.  Thus, “the authority to conduct multidistrict litigation does not alter the inherent limits on a district court to manage only its docket at the exclusion of cases beyond the MDL.”  The PLC endeavored to evade this limitation by recharacterizing the assessments as recoveries from counsel rather than the Hair Relaxer claimants. But recoveries come from the clients, and the MDL court is not permitted to pick the pockets of clients who are not in the MDL. 

Contract Law

A contractual agreement among counsel to pay holdbacks would be enforceable, but that sort of participation agreement simply did not exist here.  (This is further proof that the objecting plaintiff firm was plenty smart.). 

Assessment

The objecting plaintiff firm did not win on every issue.  It argued that the PLC’s proposed 11% assessment was “extremely high” and “premature.”  On this issue the court sided with the PLC, not the objector.  The court sort of looked at comps, the way house hunters do. The court found multiple MDLs with common benefit holdbacks between 8% and 16%, and concluded that the 11% figure (coincidentally amounting to a third of a third) was an appropriate amount for those plaintiffs in the MDL.  The objector argued that the 11% figure was inappropriate in a case, such as the Hair Relaxer MDL, where the plaintiffs claimed that the product gave them cancer.  The court saw no support for this argument. So the PLC will get paid what it wants, but the sources of such payment were circumscribed. 

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If you are of a certain age and are presented with a trio of items, we bet you sometimes add “Oh My” to the end of the list, as in Lions, and Tigers, and Bears-Oh My.  Or, you think of other things that come in threes, such as the past and the present and the future; faith and hope and charity; the heart and the brain and the body.  That’s because Three Is a Magic Number.  Three issues were certainly magical for the defendants in Higginbottom v. Dexcom, Inc., — F.Supp.3d –, 2024 WL 3823023 (S.D.Cal. Aug. 13, 2024).

The products at issue were a continuous glucose monitoring system and an insulin pump that are used together to monitor the blood sugar of and deliver insulin to people with diabetes.  Plaintiff alleges that her son’s glucose monitor reported an inaccurate high glucose level that led to his administering himself a corrective insulin bolus.  Shortly thereafter, the pump delivered another bolus causing plaintiff’s son to become hypoglycemic while driving and led to a fatal car accident.  The delivery of boluses in close proximity is known as insulin stacking.  Id. at *3.  Plaintiff brought claims against the manufacturers of both devices for design defect, manufacturing defect, failure to warn, and wrongful death.  Defendants removed the case to federal court.  Plaintiff moved to remand and defendants moved to dismiss.  All three motions were decided in defendants’ favor.

Snap Removal:  The pump manufacturer is a forum defendant who removed the case before it was served.  Plaintiff challenged the removal on several unsuccessful grounds.  First, she argued the notice of removal was docketed by the clerk a few hours after defendant was served with the complaint.  But the time of docketing does not control.  The time of filing does, and that took place an hour before defendant was served.  Id. at *4.  Second, plaintiff took a run at asking the court to reject snap removal.  While the Ninth Circuit has not yet decided the issue, the plain language of the statute coupled with decisions by four other circuits upholding snap removals persuaded the court here.  Id. at *5-6.  Third, plaintiff argued the removing defendant did not have the consent of its co-defendant to remove.  But consent was not needed because the co-defendant had not been served at the time of removal.  Id. at *7.  Next, plaintiff tried to secure a remand because defendant did not attach the complaint and other filings from state court to its notice of removal.  However, defendant is only required to attach those documents it has been served with, and even if some were missed that is a curable defect and not a sufficient basis for remand.  Id.

Having made all the standard remand arguments, plaintiff tried a novel argument—that the case should decline jurisdiction under the Colorado River abstention doctrine.  The Supreme Court, in Colorado River Water Conservation Dist. v. United States, 424 U.S. 800, 817 (1976), held that there may be circumstances where “conservation of judicial resources and comprehensive disposition of litigation” may justify staying or dismissing a federal proceeding pending resolution of concurrent state court proceedings.  However, such circumstances are “exceedingly rare.”  Higginbottom, at *8.  Plaintiff’s abstention request is based on 42 pending California state court cases against the manufacturer of the glucose monitor.  In other words, plaintiff asked the court to hold that a federal court cannot hear a case against a defendant if a different plaintiff has brought similar claims against that defendant in state court.  Concurrent state and federal litigation is more normal than not, including in mass torts.  In fact, many federal MDLs have order and procedures in place to coordinate with state court litigations.  So, plaintiff’s abstention request was a long shot at best.    

Utilizing a multi-factor test adopted by the Ninth Circuit, the court found on balance that remand was not appropriate.  There was no convenience issue as both the federal and state forums were located in San Diego.  The possibility of piecemeal litigation is not enough.  There must be a special concern “which can be remedied by staying or dismissing the federal proceeding.”  Id.  Duplicative cases are not “particularly problematic.”  While the state court cases were filed earlier, the underlying legal claims had not yet been ruled on, making order of filing more of a net neutral factor.  Id. at *9.  Similarly, California federal courts routinely apply California state law, so this factor did not weigh against federal jurisdiction.  Federal courts should not relinquish jurisdiction if the state court proceeding “cannot adequately protect the rights of the federal litigants.”  Id. But where both forums are adequate, this factor carries less weight.  Courts also consider forum shopping in deciding whether to abstain.  Here, snap removal could be considered forum shopping, and so this factor alone leaned in favor of remand.  But the final factor was probably the most significant in this case—whether the state court proceeding “sufficiently parallels” the federal proceeding. The pump manufacturer is not a defendant in any of the 42 pending state court cases, therefore, resolution of those cases “will not resolve the claims before this court.”  Nor is plaintiff a party of any of the state court cases.  Overlapping issues are not enough four a court to invoke Colorado River abstention.   

Having decided it was keeping the case, the court next turned to each defendant’s motion to dismiss.  For the pump manufacturer, TwIqbal won the day.  Defendant argued that it should be entitled to express preemption under Riegel, but there was some ambiguity regarding whether the device was PMA approved or whether parts were Class II.  So, court decided to kick that can down the road and focus instead on the insufficiency of the pleadings.  Plaintiff conceded she had not adequately pleaded a manufacturing defect.  On design defect under a negligence theory, plaintiff alleged that the pump manufacturer knew the glucose monitor could give inaccurate readings creating a risk of insulin stacking.  But that allegation is about the glucose monitor, not the pump.  The complaint lacked any supported allegations identifying a defect in the pump or how that defect was the result of the manufacturer’s negligence.  Id.  at *15.  As to strict liability design defect, California does not recognize such a claim for prescription medical devices.  On failure to warn, while plaintiff identified a risk—insulin stacking—she did not allege it was a risk that a “reasonably prudent manufacturer would have known and warned about.”  Id. at *16.  Moreover, plaintiff failed to allege anything about plaintiff’s son’s prescribing physician.  Notably, whether his physician would still have prescribed the pump if a different warning had been given.  Id.  Under the learned intermediary doctrine recognized by California, this is a necessary piece to establish causation.  Due to the deficiencies in pleading all three defect claims, all three were dismissed without prejudice. 

The manufacturer of the glucose monitor likewise moved to dismiss all claims as expressly preempted because the monitor was approved through the FDA’s De Novo classification process “with the establishment of special controls” by the FDA to “provide reasonable assurance of the safety and effectiveness of the device for its intended use.”  Id. at *18.  If this sounds familiar, it’s because this is the second de novo preemption win for this defendant in just under one month.  We blogged about the first win here, which sets out the same rationale used by the court in Higginbottom.  Essentially it is a recognition that the PMA process is not the only circumstance in which the FDA can establish device specific requirements that satisfy the first prong of Riegel.  Because the FDA imposed device-specific labeling requirements, plaintiff’s claim that defendant is liable for failing to provide different or additional warnings is expressly preempted.  Id. at *20.

Unfortunately, plaintiff is being given an opportunity to amend her complaint to try to assert a non-preempted claim.   But as you children of the 70s know, “it takes three legs to make a tripod or to make a table stand.”  This decision strips away a couple of legs and leaves the case with a wobbly future.   

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In Cajun French “tracas” means trouble, or so the Internet says.

Bexis is updating the learned intermediary rule section of his product liability treatise, and he noticed a little tracas brewing in Louisiana.  We’re calling it out so that defense counsel litigating in Louisiana are aware of it and (we hope) can do something about it.

Plaintiffs in Louisiana semaglutide litigation are attempting turn the learned intermediary rule into an “affirmative defense.”  But it isn’t, hasn’t been, and never should be.  Three recent decisions – all in the same litigation – all have the same bogus holding:

The learned intermediary doctrine is an affirmative defense on which defendant bears the burden of proof.  Brocato v. DePuy Orthopaedics, Inc., 2015 WL 854150, at *6 (E.D. La. Feb. 25, 2015) (citing Ebel v. Eli Lilly and Co., 536 F. Supp.2d 767, 772 (S.D. Tex. 2008)).

See Breaux v. Novo Nordisk Inc., 2023 WL 8606799 at *3 (W.D. La. Dec. 12, 2023); Bjorklund v. Novo Nordisk A/S, ___ F. Supp.3d ___, 2023 WL 8528445 at *2 (W.D. La. Dec. 8, 2023); Bjorklund v. Novo Nordisk A/S, 2023 WL 8584961 at *2 (W.D. La. Dec. 11, 2023).  That’s the sum total of the discussion in those cases.

So we next look at Brocato.  The discussion in Brocato was also a single sentence, supported by two citations:

The “learned intermediary doctrine” is an affirmative defense under which Defendants bear the burden of establishing that they adequately informed the intermediate physician of the risks associated with use of their product.  See, e.g., Ebel v. Eli Lilly and Co., 536 F. Supp.2d 767, 772 (S.D. Tex. Jan. 29, 2008) (citing Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974) (“Defendant has the initial burden of proving that decedent received the medication through a physician with whom the decedent had a physician-patient relationship and that the warning Defendant provided to the prescribing physician was adequate.”).

2015 WL 854150, at *6.

But neither Ebel nor Reyes applied Louisiana law.  They were both diversity cases predicting and applying Texas law.  Reyes, 498 F.2d at 1271 (applying “those principles of products liability law we conclude would be applied by the courts of Texas”); Ebel, 537 F. Supp. at 772 (interpreting “[t]he Texas learned intermediary doctrine”).  Applying Louisiana law, however, the Fifth Circuit has held that the burden of proof in learned intermediary cases remains where it is supposed to be – on the plaintiff:

[T]here is a two-prong test governing inadequate-warning claims under the LPLA when the learned intermediary doctrine is applicable.  First, the plaintiff must show that the defendant failed to warn (or inadequately warned) the physician of a risk associated with the product that was not otherwise known to the physician.  Second, the plaintiff must show that this failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff’s injury.

Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 265 (5th Cir. 2002) (applying Louisiana law) (emphasis added).  Stahl cited Willett v. Baxter International, Inc., 929 F.2d 1094 (5th Cir. 1991), for these propositions, and did so correctly:

To recover for a failure to warn under this [learned intermediary] doctrine, a plaintiff must show:  (1) that the defendant failed to warn the physician of a risk associated with the use of the product, not otherwise known to the physician, and (2) that the failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff’s injury.  Because the defective aspect of the product must cause the injury, the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e. that but for the inadequate warning, the treating physician would not have used or prescribed the product.

Willett, 929 F.2d 1094, 1098-99 (emphasis added).

How about Louisiana state appellate courts?  Louisiana has followed the learned intermediary rule in multiple cases since 1983.  See Ezeb v. Sandoz Pharmaceuticals, 50 So.3d 166, 170 (La. App. 2010); Stanley v. Wyeth, Inc., 991 So. 2d 31, 33-34 (La. App. 2008); Kampmann v. Mason, 921 So.2d 1093, 1094 (La. App. 2006); Marks v. Ohmeda, Inc., 871 So.2d 1148, 1157 (La. App. 2004); Brown v. Glaxo, Inc., 790 So.2d 35, 38 (La. App. 2000); Calhoun v. Hoffman-LaRoche, Inc., 768 So.2d 57, 61 (La. App. 2000); Mikell v. Hoffman-LaRoche, Inc., 649 So.2d 75, 79-80 (La. App. 1994); Rhoto v. Ribando, 504 So.2d 1119, 1123 (La. App. 1987); Kinney v. Hutchinson, 468 So.2d 714, 717 (La. App. 1985); Cobb v. Syntex Laboratories, Inc., 444 So.2d 203, 205-06 (La. App. 1983).  None of these cases has considered the learned intermediary rule to be an “affirmative defense.”  None of these decisions have held that defendants, not plaintiffs, have the burden of proving the factual prerequisites of the rule.  To the contrary, they hold, like the Fifth Circuit, that plaintiffs retain their ordinary burden of proof.

The learned intermediate [sic] doctrine states that the drug manufacturer has no duty to warn the customer directly and that the manufacturer’s duty is fulfilled when the prescribing or treating physician is informed of the risks from the drug use.  It is then the physician’s responsibility to advise the patient.  However, there is a two-prong test in failure to warn LPLA claims.  First, the plaintiff must show that the defendant failed to warn (or inadequately warned) the physician of a risk associated with the product that was not otherwise known to the physician.  Second, the plaintiff must show that this failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff’s injury.

Ezeb, 50 So.3d at 170 (La. App. 2010) (citing and quoting Stahl) (emphasis added).

That should be quite enough, but there’s more.  The two Texas decisions mentioned above, Reyes and Ebel, are not even accurate as to Texas law.  Subsequent to those two decisions, the Texas Supreme Court has flatly rejected the contention that the learned intermediary rule was an affirmative defense – explicitly and at length:

IV.       The Learned Intermediary Doctrine Within the Prescription Drug Context Is Not a Common–Law Affirmative Defense

The parties dispute whether the learned intermediary doctrine is an affirmative defense, which would shift to [defendant] the burden to plead, prove, and request jury findings on the learned intermediary doctrine at trial.  We agree with [defendant] that, within the prescription drug context, the learned intermediary doctrine is more akin to a common-law rule rather than an affirmative defense.

*          *          *          *

[F]or more than forty-five years, courts have applied the learned intermediary doctrine within products-liability claims against prescription drugs manufacturers.  We have repeatedly referenced the doctrine’s commonly recognized application in the prescription drug context. . . .  [D]octors have a legal duty to pass prescription drug warnings on to their patients. And as the official comment to the Restatement (Second) of Torts notes, the learned intermediary doctrine applies particularly to the medical field and unavoidably unsafe products like prescription drugs, which, by law, cannot go from the manufacturer to the end user except through a prescribing physician.

*          *          *          *

Here, it is undisputed that [plaintiff] received [the drug] through a physician-patient relationship. . . .  [T]he underlying basis for the . . . claims stems from [defendant’s] alleged failure to warn [plaintiff] of the risks and dangers associated with [the drug].  Therefore, as in most failure-to-warn cases, the [plaintiffs] had to prove that [defendant’s] warning was inadequate.  While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiff’s basic burden of proof. Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case − that the product warning was inadequate.  The burden on defendants in other industries to show reasonable reliance on an intermediary to effectively deliver a warning has no application in products-liability cases against a prescription drug manufacturer when the plaintiff received the drug through the existence of a physician-patient relationship.

Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 164-67 (Tex. 2012) (citations and footnotes omitted) (emphasis added).

And there’s even more. In the Ebel litigation itself, the Fifth Circuit expressly held that – contrary to any purported “affirmative defense” – the plaintiff retains the burden of proof in learned intermediary cases.  “When, as here, the learned intermediary doctrine applies, ‘a plaintiff must show that (1) the warning was defective, and (2) the failure to warn was a producing cause of the injury.’”  Ebel v. Eli Lilly & Co., 321 Fed. Appx. 350, 355 (5th Cir. 2009) (emphasis added) (quoting Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 208 (5th Cir. 2008)).

Finally, just to make the rubble bounce, we point out  that the California Supreme Court reached the same conclusion in its recent Himes decision (discussed generally here).  California’s highest court reached the same result as all the appellate decisions we discussed above, rejecting any argument that the learned intermediary rule was an affirmative defense:

[T]he learned intermediary doctrine is neither a defense nor an exception to a traditional duty rule, and it does not cease to apply where a plaintiff alleges that a manufacturer failed to provide an adequate warning to the patient’s physician.  It instead defines the scope of a manufacturer’s duty to warn in context of prescription drugs or medical devices by providing that the manufacturer’s duty to warn runs to the physician, not to the patient.

Himes v. Somatics, LLC, 549 P.3d 916, 924 (Cal. 2024) (citations and quotation marks omitted).

Thus, the identical statements in the three recent Louisiana semaglutide decisions, and in the earlier Brocato case, that the learned intermediary rule is an “affirmative defense” are completely wrong – what we call “spherical error” because they are erroneous any way you look at them.  In the future, counsel litigating in Louisiana should point this out loud and clear.

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Both sides in Gilead v. Superior Court have filed their opening briefs in the California Supreme Court, and the extreme nature of the California Court of Appeal’s opinion extending a manufacturer’s duties has been laid bare.  As expected, the defendant convincingly argued that the California Court of Appeal has imposed potentially unlimited liability on product manufacturers through a duty to develop and commercialize safer alternative products without delay.  The plaintiffs, for their part, did not disavow the breadth of this duty, but asserted that it has existed for more than 100 years, even though no one saw it before they did, and that juries are capable of sorting it all out. We have no idea what the California Supreme Court will do with all this, but we hope and expect that the Court of Appeal’s novel duty to innovate will come under heavy scrutiny. 

As we explained here and here, the plaintiffs in Gilead used HIV drugs known as “TDF.”  But rather than allege that TDF drugs were defective, the plaintiffs asserted that that the defendant was negligent in failing to bring a different, but allegedly safer HIV drug (“TAF”) to market sooner.  The Court of Appeal ruled that a prescription drug manufacturer can owe such a duty, even when the plaintiffs have not alleged any defect in the drug that they actually used.  In an unprecedented ruling, the Court of Appeal found a duty of reasonable care when a manufacturer has invented “what it knows is a safer, and at least equally effective, alternative to a prescription drug that it is currently selling and that is not shown to be defective.”  Gilead Sciences, Inc. v. Superior Court, 98 Cal. App. 5th 911, 922 (2024) (review granted).

The California Supreme Court granted review.

The defendant’s opening brief established the major theme in its opening sentences:  “The Court of Appeal overrode a century of common law to impose on manufacturers a duty that no court anywhere in the county has ever suggested.  Whereas the common law requires manufacturers to product non-defective, reasonably safe products, the Court of Appeal has added a duty to develop and commercialize, without delay, a different product that is safer for some consumers.”  The key here is that the TDF drugs these plaintiffs actually took were not defective, which is an essential element of product liability claims.  As the defendant explained, California’s general negligence statute—which has been on the books since 1872—imposes a duty of care, but that duty is to produce reasonably safe product, i.e., products free of defect in manufacture, design, and warnings. 

The Court of Appeal departed from that standard and enacted in its place a rule that has no meaningful benchmark for a manufacturer’s conduct and transforms every product development decision into a potential lawsuit.  The defendant thus made its pitch in four parts.  First, the defendant laid out in detail the product development cycle that led to the marketing of TDF drugs, which undisputedly saved and extended thousands of lives.  At the time, the TAF drugs that plaintiffs (and the Court of Appeal) touted as “safer” had been subject to a single early trial involving just 20 patients, and the results were mixed.  The central premise behind this new duty—that the defendant “knew” that TAF drugs were “safer and at least equally effective”—is counterfactual and should not have been taken as a foregone conclusion. 

Second, the defendant argued that all product liability claims—whether couched in negligence or in strict product liability—require proof that a defect in the product caused injury.  This is the law in every jurisdiction, and it represents more than 100 years of legal calibration that balances product safety against product access.  This is particularly important in the pharmaceutical context, where all products have risks, yet are essential to protecting life and promoting health.  In sum, “[The Supreme] Court’s repeated pronouncements that a plaintiff claiming injury from a product cannot recover from a manufacturer without proving a defect are grounded in history and sound policy.”  A general negligence claim under California’s general negligence statute does not displace these rules.  It subsumes them. 

Third, the defendant emphasized the “unwarranted, unjustified, and disastrous” nature of the specific duty that the Court of Appeal created.  The new duty essentially requires that every manufacturer develop and commercialize an alternate product that it knows to be safer for some subset of consumers, and to do so without delay.  In other words, “reasonably safe is no longer safe enough.”  The new rule has no identifiable boundaries; it creates a “backdoor to liability” for products that are reasonably safe to begin with; and it is contrary to California Supreme Court precedent rejecting a comparable duty because it would chill the development of beneficial drugs.  The defendant provided multiple provocative examples:  Should an auto manufacturer be liable for injuries caused by speeding if it “knew” of technology that would prevent cars from exceeding the speed limit?  Should a seller of N-95 masks be liable for infections where it “knew” of full-face respirator technology that was marginally more effective?  The Court of Appeal’s legal framework was mistaken because it applied California’s Rowland factors to override the defect requirement without analyzing its history and rationale.  And, when applying the Rowland factors, they weigh clearly against imposing the new duty.

Fourth, at a minimum, any duty to develop and bring a “safer” alternative to market cannot be imposed so early in the product development cycle.  It is neither fair nor legally sustainable to create a duty because a drug manufacturer “knew” of a “safer and at least equally as effective” based on a single early-phase trial involving 20 patients. 

The plaintiffs’ opening brief adopts the theme that drug manufacturers owe a duty of care “when making decisions about commercializing an allegedly safer and equally effective drug” under California’s general negligence rule.  They presented their version of the defendant’s product development; they rejected the idea that the Court of Appeal overrode a century of common law; and they disagreed that the new duty was “boundless.”  For the plaintiffs, they have never been required to prove a product defect to prevail in a product liability claim grounded in negligence, and public policy does not justify an exception to the general rule that a manufacturer owes a legal duty to the users of its products. 

The plaintiffs’ argument therefore was threefold.  First, they argued that California’s general negligence statute creates a “default rule” that each person has a duty to exercise reasonable care for the safety of others, separate and apart from strict product liability.  This is a core part of the plaintiffs’ position—i.e., that strict product liability and negligence are separate things, with the former requiring a defect and the latter not.  They chide the defendant for “misapprehending” this “fundamental distinction,” and they purport to cite cases allowing negligence claims separate and apart from strict liability.  The plaintiffs’ touchstone is always “reasonableness,” and they claim that the “defect requirement” is especially misguided in the pharmaceutical context because of widespread application of federal preemption, the “near blanket immunity pharmaceutical manufacturers enjoy,” and “multiple safe harbors.”  In plaintiffs’ view, negligence is “one of the only avenues” left to challenge drug manufacturers.   

Second, the plaintiffs emphasized that the defendant did not justify an “exception” to the general duty of care.  Here, the plaintiffs discuss California’s Rowland factors, as too did the defendant, but plaintiffs come to the opposite result and argue that foreseeability and public policy factors weigh in favor of imposing this duty.  Plaintiffs particularly emphasize the defendant’s knowledge—i.e., that defendant purportedly knew that TAF drugs would reduce or eliminate side effects and would be at least as effective as TDF.  From that premise, it is no wonder that plaintiffs would conclude that the defendant foresaw harm to others and was “morally blameworthy.”  In so arguing, the plaintiffs accuse the defendant of ignoring “context,” and they dismiss the idea that the duty imposed by the Court of Appeal will adversely impact innovation and result in fewer choices for consumers. 

Third, the plaintiffs reject the argument that a duty to bring a product to market cannot possibly be imposed so early in the development process.  Again they fall back on what the defendant “knew,” despite having conducted just one early-phase trial.  According to the plaintiffs, a pharmaceutical manufacturer should not be allowed to “immunize” itself from liability by delaying Phase III trials. 

This is a thumbnail sketch of the parties’ substantial opening briefs, but you get the gist.  As usual, we have a few observations from our defense-minded point of view. 

First, the plaintiffs stake their case largely on the difference (the “fundamental distinction”) between negligence and strict product liability and how one claim can survive absent the other.  But everyone agrees that California law provides for both negligence and strict liability.  The question here is what a negligence claim under California law should look like.  The defendant has made a convincing case that a negligence claim against a product manufacturer requires proof that there is something wrong with the product—a defect.  The fact that strict product liability is separate and also requires proof of a defect is beside the point. 

Second, the plaintiffs accuse the defendant of ignoring “context,” but the defendant is merely emphasizing just how broadly this new duty will affect manufacturers and consumers throughout California—including in industries other than pharmaceuticals.  Plaintiffs can try to cabin the issue and emphasize how “narrow” the Court of Appeal’s new duty is, but this is California’s highest court.  In interpreting California law, the Supreme Court will see the broader picture.

Third, the plaintiffs doubled down on the defendant’s purported knowledge that TAF was “safer” and at least equally as effective to support the new duty.  They probably had no choice, as the Court of Appeal staked its opinion so firmly on that factor.  We are, however, confused.  If culpable knowledge is required, we still wonder whether this is even a negligence claim.  Moreover, the plaintiffs appear to waffle.  They emphasize actual knowledge in parts of their brief, but in others they refer to constructive knowledge and what a manufacturer “knew or should have known.”  The plaintiff’s Issue Presented does not mention the defendant’s knowledge at all.  Are plaintiffs hedging here, maybe planning to pivot on remand?  We don’t know. 

Fourth, we chuckled (and not in a good way) at plaintiffs’ assertions that pharmaceutical manufacturers enjoy “near blanket immunity” and “multiple safe harbors” in California state court.  That state of affairs will come as a stunning surprise to pharmaceutical companies collectively facing hundreds of thousands of product liability lawsuits in Los Angeles and other large California counties. 

Fifth, the parties have much to say on the Rowland factors.  Parties always do, and like many multi-factor tests, the analysis can be result oriented.  What strikes us is the fundamental dispute over how the Rowland factors should apply—whether a defendant bears the burden of proving an “exception” to the general duty of care or whether a plaintiff bears the burden of proving that a duty arises in the first instance. This issue might strike the Supreme Court as interesting, too. 

Finally, the plaintiffs’ refrain is that “reasonableness” is the standard, which purportedly solves all problems.  We have no issue with reasonableness, but juries decide whether someone has acted reasonably when determine whether a duty has been breached.  The question here is whether that person owes a duty in the first place. 

So that’s our take.  The defendant still has one more brief to go, then it’s on to oral argument.  We continue to believe that the Court of Appeal’s new duty is unwarranted and completely gratuitous.  Pharmaceutical manufacturers do not enjoy “blanket immunity” in California, and product users in California are amply protected by 100+ years of product liability law.  We will keep you posted. 

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This post is from the non-Butler Snow side of the blog.

When a news article starts with “Florida man…” you know you are in for a bit of crazy.  Usually crazy and funny, but in a smack-my-head kinda way.

The lawsuit resulting in the decision in MSP Recovery Claims, Series LLC v. Ethicon Inc., et al., Case No. 1:19-CV-650-RWS, 2024 U.S. Dist. LEXIS 145933, 2024 WL 3811994 (N.D. Ga. Aug. 13, 2024), started in Florida, and involves two odd things:  the Florida pure bill of discovery procedure, and the Medicare Secondary Payer Act (“MSP Act”), 42 U.S.C. § 1395y, et seq. 

It is a bit crazy, and in a smack-my-head kinda way, so we tried to come up with a “Florida man/Florida lawsuit”-type title for this post.  But this is a legal blog and the opinion falls short on the funny, so we gave up and now will go straight to the issues.

As noted, today’s case started in Florida state court as a “pure bill of discovery” action, before it was removed to federal court and transferred to an MDL. 

The Florida pure bill procedure, codified in Fla. Stat. § 26.01(2), is an anachronism, a hold-over from olden, code-pleading times, and something that probably should no longer be on the books but unfortunately still is.

“Although a pure bill of discovery remains part of [Florida’s] legal system, its use and usefulness diminished greatly when Florida relaxed its pleading requirements to authorize liberal discovery.”  Venezia Lakes Homeowners Ass’n v. Precious Homes at Twin Lakes Prop. Owners Ass’n, 34 So. 3d 755, 758 (Fla. 3d DCA 2010) (internal quotations and citation omitted).

“The pure bill of discovery originated in equity as a mechanism for obtaining ‘the disclosure of facts within the defendant’s knowledge, or deeds or writings or other things in his custody, in aid of the prosecution or defense of an action pending or about to be commenced.’”  Vorbeck v. Betancourt, 107 So. 3d 1142, 1145 (Fla. 3d DCA 2012) (citation omitted).

In theory, “[u]nder the current state of the law, the filing of a bill of discovery is justified only in ‘narrow and limited circumstances.’” Id. at 1145.  The cases also tell us that a pure bill is not supposed to substitute for filing a valid complaint and seeking ordinary discovery, and it is not a “mechanism to determine whether a cause of action exists or as a ‘fishing expedition.’”  Trak Microwave Corp. v. Culley, 728 So. 2d 1177, 1178 (Fla. 2d DCA 1998). 

But where a mechanism for obtaining the disclosure of facts within the defendant’s knowledge ends and a fishing expedition begins probably depends on the day of the week and whether your assigned judge had a good breakfast or got up on the wrong side of the bed.

This particular Florida pure bill was filed by entities called “MSP Recovery Claims, Series LLC; MSPA Claims 1, LLC; and MAO-MSO Recovery II LLC, Series PMPI”, which the court described as “a group of companies that specialize in acquiring and pursuing Medicare Secondary Payer claims.”   

One court described such MSP Recovery entities as filings complaints that “read as if plaintiffs began with a conclusion that defendants owed them money and simply worked backwards to construct a legal theory that would support the conclusion.”  MAO-MSO Recovery II, LLC v. Am. Fam. Mut. Ins. Co., No. 17-cv-175, 2018 U.S. Dist. LEXIS 23146, 2018 WL 835160, at *6 (W.D. Wis. Feb. 12, 2018).   

In this case, the MSP Recovery plaintiffs sought information they hoped would allow them to file claims against medical device manufacturers using the MSP Act.  According to the plaintiffs, they had been assigned MSP Act claims by certain Medicare Advantage Organizations.  These assignments supposedly permitted them to seek reimbursement of money the Medicare Advantage Organizations had paid for their insureds’ medical care, because the defendant manufacturers should have paid for that medical care instead (purportedly because the medical device was defective and allegedly caused the insureds to need the medical care).

What information did these plaintiffs seek, you may ask?  Merely an order directing the defendant manufacturers of a medical device, Physiomesh, to produce, without notice to or consent by the affected individuals, some pretty highly confidential personal information, namely:

“(1) full name of each Physiomesh recipient; (2) Social Security, health insurance claim number, or Medicare beneficiary identifier for each Physiomesh recipient; (3) the date of birth of each Physiomesh recipient; and (4) the address of each Physiomesh recipient.”

According to the plaintiffs, they needed the pure bill of discovery to learn these personal details who had received the medical device, so they would know who to sue and what Medicare claims were at issue.

Whether a medical device manufacturer would have this information is questionable, unless the FDA ordered tracking to the patient level for the device.  See Medical Device Tracking: Guidance for Industry and Food and Drug Administration Staff (March 27, 2014), available at https://www.fda.gov/media/71205/download.

By contrast, one would think that plaintiffs actually assigned valid MSP Act claims by Medical Advantage Organizations already would have this information, or access to this information through the insurers that assigned them the claims.  These Medical Advantage Organizations surely would have access to their own insureds’ insurance and medical records, and those records should reveal which insureds had been implanted with the medical device, whether the Medical Advantage Organization had paid for any post-implant care related to the device, and other such information. 

One thus would think that plaintiffs’ Florida pure bill action against medical device manufacturers would not be necessary.  (And one would be right:  See MSP Recovery Claims, Series, LLC, et al., v. Bristol West Ins. Co., Case No. 19-32-CA-01 (Fla. 11th Cir. Ct. May 25, 2020) (pure bill of discovery not allowed where the plaintiffs “already [knew] the hoped-for cause of action and the identity of the intended defendant” and the pure bill of discovery sought “protected private medical and financial information about individual Medicaid recipients who are not parties or clients of Plaintiffs’ counsel”).)

But the litigation strategies of the MSP Recovery entities (now apparently sometimes known as LifeWallet) are passing strange.  See, e.g., MSP Recovery Claims, Series LLC v. USAA Gen. Indem. Co., No. 18-cv-21626, 2018 WL 5112998, at *10, *13 (S.D. Fla. Oct. 19, 2018) (describing plaintiff as having “played fast and loose with facts, corporate entities, and adverse judicial rulings”); MAO-MSO Recovery II, LLC v. State Farm Mut. Auto. Ins. Co., No. 1:17-cv-01541, 2018 WL 2735106, at *4–5 (C.D. Ill. June 7, 2018) (imposing Rule 11 sanctions for “misstatements” and “inaccurate allegations” about assignments).

At this point, you may be ready to exclaim, “WTF?” (meaning, of course, “What The Florida?”).  Fortunately, the court dismissed this case, on personal jurisdiction grounds.   

Turning to the Florida long-arm statute, the court recognized that in the specific jurisdiction context, Florida “requires a closer nexus” (or “connexity”) between the state and the activity in question than would be required by the federal Due Process Clause.

Here, defendants were non-Florida businesses that manufactured the medical device in question.  If those devices allegedly injure a Florida patient, the connection between the manufacturer and Florida might (or might not) be enough for Florida to exercise personal jurisdiction over the manufacturer for product liability purposes.  But when the case involves a pure bill of discovery premised on Medicare payment obligations, an out-of-state defendant definitely does not have a close enough connection to Florida just because it manufactured a medical device.  Following MSP Recovery Claims v. Coloplast Corp., 353 So. 3d 705 (Fla. 3d DCA 2023), the court recognized that the plaintiffs’ pure bill of discovery action did not relate to any “injury to persons” or tort in Florida, nor to any business the defendants were carrying on in Florida. The case thus failed for lack of personal jurisdiction over the defendants.  

If this odd case had survived the personal jurisdiction challenge, it may well have been dismissed on other grounds, such as standing, questionable validity of the assignments the plaintiffs purported to have, and so on. 

In sum, despite the myriad problems with the MSP Recovery plaintiffs’ whole litigation scheme and the Florida pure bill of discovery procedure, this MSP Recovery Claims, Series LLC case was bounced on a very important foundational ground: personal jurisdiction.  A good result, and one we are happy to see, whatever the basis.

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This post is not from the Bryan Cave side of the Blog.

The Third Circuit’s preemption decision in Schaffner v. Monsanto Corp., ___ F.4th ___, 2024 WL 3820973 (3d Cir. Aug. 15, 2024), is certainly a big deal in that litigation.  As observed in the Bloomberg story about the decision, carried in the August 19, 2024 edition of the Philadelphia Inquirer, Schaffner’s ruling that “federal regulation requires health warnings on pesticide labels to conform to those approved by the Environmental Protection Agency” creates a circuit split with other Roundup decisions that we’ve criticized:

The ruling potentially sets up the case for review by the U.S. Supreme Court.  In February, another federal appeals court in Atlanta rejected the German company’s argument that federal law preempts, or trumps, state law on what warnings must be posted on pesticides. The ruling creates a split among the federal appellate courts.

But there are other implications of the Schaffner decision that have received less attention, and involve prescription medical product liability litigation.  That’s what this post is about.

First, what is not in Schaffner?  Any mention of a presumption against preemption.  Not one word.  That shouldn’t be a shock.  After all the Supreme Court explicitly killed it in express preemption cases (which is the kind of preemption Schaffner employed, 2024 WL 3820973, at *7 n.8) in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115, 125 (2016).  But contrary to every other circuit court in the federal system, a footnote in Shuker v. Smith & Nephew, PLC, refused to take the Supreme Court at its word – refusing to inter the presumption in “matters of health and safety, such as . . . products liability claims.”  885 F.3d 760, 711 n.9 (3d Cir. 2018).  Schaffner also involved product liability claims, and the erstwhile presumption was nowhere to be found.  If anything, the opposite is true.  Where “uniformity” is one of the things Congress intended to achieve, preemption “best achieves [that] stated aim.”  2024 WL 3820973, at *21.

Second, Schaffner rejected the use of offensive non-mutual collateral estoppel in MDLs – something else we’ve criticized.  One of the adverse preemption decisions that Schaffner disagreed with arose in the context of the Roundup MDL.  Plaintiffs in Schaffner contended that the Third Circuit was bound to follow that decision due to collateral estoppel or “law of the case.”  Schaffner held otherwise.  Law of the case exists only in the context of the “same case.”  2024 WL 3820973, at *5.  The Supreme Court has held that individual MDL plaintiffs’ cases “retain their separate identities,” so an appellate decision in one MDL case had no effect on any other.  Id. (quoting Gelboim v. Bank of America Corp., 574 U.S. 405, 413 (2015)).  That ruling may help us, or hurt us, in any particular MDL, but given the widespread use of the law itself (preemption, public nuisance, other novel state-law theories, restrictive evidentiary rulings) as a settlement weapon in MDLs, on balance we favor that position.

Offensive, non-mutual collateral estoppel is even worse, and Schaffner refused to employ it to legal questions, such as preemption:

Applying issue preclusion to a pure question of law . . .  risks impeding a court from discharging its function of developing the law. . . .  [This] identifies an equitable factor that courts may consider in deciding whether to apply issue preclusion non-mutually. . . .  [W]e conclude that both circumstances requiring that the rule of preclusion should ordinarily be superseded are present.  The appellate courts to which appeals were taken . . ., the Court of Appeals for the Ninth Circuit and this Court −  have coordinate jurisdiction.  And the issue presented by this case, which is clearly of general interest, has yet to be decided by the highest court capable of resolving it − the United States Supreme Court.  We therefore . . . exercise[e] our broad discretion . . . [and] decline to apply issue preclusion and instead develop the law of express preemption . . . ourselves.

2024 WL 3820973, at *6 (citations and quotation marks omitted).

Third, while we have serious issues with “parallel requirements” as an express preemption test, given that it was merely dictum in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), by now it is so deeply entrenched now that only the Supreme Court could change it.  Schaffner applied such a test, 2024 WL 3820973, at *7, and did so in a defense friendly fashion.  The Third Circuit recognized that the FDCA “closely echo[s] the language employed by FIFRA’s preemption provision.”  Id. at *13.  Both use the operative phrases “in addition to” and “different from” to define the state “requirements” that are preempted, only in different order.  Id.  “Like pesticides, medical devices must be reviewed and approved before being marketed, and once approved they cannot be modified unless the proposed modification is itself reviewed and approved.”  Id.

[Riegel’s] conclusions and reasoning shed light on whether, in general, a “requirement” exists within the meaning of a similar preemption provision, such as FIFRA’s, where an agency reviews regulated products for safety before they may be marketed, then prohibits modifications of those products absent an additional safety review.

Id.  In Schaffner, the cancer warning plaintiffs advocated would have changed an agency-approved “precautionary statement” (that is, a warning), and thus could not escape preemption as a “minor” modification.  2024 WL 3820973, at *10.  In both the FIFRA and FDCA regulatory schemes, only minor modifications can be made without prior agency pre-approval.

Fourth, Schaffner held that the entire panoply of agency regulatory decisions – not just the broad, vague provision of the FIFRA statute’s “misbranding” provision – apply in the determination of what is expressly preempted.  As was unsuccessfully attempted in Schaffner, prescription medical product plaintiffs often try to use the FDCA’s equally broad and vague misbranding or adulteration provisions, standing alone, to avoid preemption.  Schaffner said no.

If [federal] regulations specifically identify the contents required to be included on a pesticide label, a state-law requirement is preempted unless it is equivalent to that specific regulatory requirement.  The state-law duty cannot survive preemption simply because its standard of liability is equivalent to the broad statutory definition of misbranding.

2024 WL 3820973, at *15.  Where agency regulations and approvals have “give[n] content to [statutory] misbranding standards,” then “any equivalence between the state-law duty and the statutory definition of misbranding does not prevent the preemption of state law.”  Id.

Fifth, in PMA preemption cases, one of the pitched battles that plaintiffs and defendants fight in almost every case, is whether claimed violations of non-specific FDA manufacturing practice regulations, that could be read to require different things in different cases, are sufficient to state parallel claims.  The same problem arose in the FIFRA context in Schaffner, and the Third Circuit resolved it in favor of preempting non-specific violation claims.  “If state-law duties to warn can survive preemption so long as they are equivalent to . . . broad” enactments, then “[s]tate-law duties framed in these vague and broad terms would produce considerable heterogeneity.”  Id. at 17.  Preemption is necessary because “different factfinders deciding different individual cases might reasonably disagree about whether a particular warning was necessary to protect health.”  Id.  That’s exactly the problem posed by purported FDCA parallel violation claims predicated on vague FDA CGMPs.  Now, in the closely analogous FIFRA context, Schaffner has resolved the same issue in favor of allowing only specific violation claims to escape preemption.  The claim in Schaffner was “preempted because of the specific requirement imposed through” the product’s approval process, “which prohibits the modification of [the] Label without further [regulatory] approval.”  Id. at *19.

Sixth, and finally, Schaffner held that “force of law” was not a prerequisite to express preemption.  2024 WL 3820973, at *20.  That requirement originated in Wyeth v. Levine, 555 U.S. 555 (2009).  But Levine “did not interpret a statutory provision that expressly preempted state law” – only  “the distinct doctrine of implied preemption.”  2024 WL 3820973, at *20.  Where Congress has imposed preemption expressly, the preemption provision itself supplies the requisite preemptive effect:

[W]hen Congress has expressly authorized the preemption of state law by statute, the meaning of the express-preemption provision triggers preemption.  [A court’s] role when confronted with an express-preemption provision is to apply the text that embodies Congress’s decision. . . .  [A]s Congress has decreed in the text of that provision that federal “requirements” have preemptive force, no further analysis is necessary.

Id. (citations and quotation marks omitted).

Just as the aviation preemption decision in Sikkelee v. Precision Airmotive Corp., 907 F.3d 701, 707 (3d Cir. 2018), disposed of the contention that Pennsylvania law allowed product liability claims based on failure to report adverse events to a federal agency, these six points in Schaffner should, by analogy, control in express preemption cases involving FDA-regulated medical devices and over-the-counter drugs.  Defense counsel practicing in Third Circuit district courts should definitely study the Schaffner decision.

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One of the break-through moments in the first year of law school is when your Contracts professor distinguishes actionable promises from mere “puffery.” Not every statement invites reliance.  You cannot take every statement by a seller literally. The concept of non actionable puffery is the law’s way of telling us to grow up, to get real.  

Right now there is a rash of consumer fraud actions where the literal is exalted over the logical.  Plaintiff attorneys pretend to be aggrieved over hyper-technical departures from “natural,” “organic,” or, Heaven help us all, “vanilla.”  

Slowinski v. Blue Triton Brands, Inc., 2024 U.S. Dist. LEXIS 142909 (N.D. Illinois Aug. 9, 2024), is about something even plainer than vanilla — water. Normally we introduce a case by describing it in colorful and, if we are lucky, clever terms. But the Slowinski decision does the work for us. It comes at us in delightful, humorous prose.  Judge Seeger begins by describing how the plaintiffs walked into a grocery store and bought water bottles that showed “a snow-capped mountain towering over an idyllic landscape, surrounded by blue skies and evergreen trees. Down below, the reflection of the mountain appears on a body of cool, refreshing, thirst-quenching water. If the ice-covered mountain doesn’t make you thirsty, then the serene glacial lake probably will.”

It seems like Judge Seeger would be mighty good at writing ad copy. He is certainly good at writing readable judicial opinions. 

Anyway, what could possibly be wrong with the picture of a snow-capped mountain?

The plaintiffs alleged that the water packaging lied when it referred to “100% Natural Spring Water.”  The plaintiffs complained that the water is contaminated with chemical compounds that come from microplastics.  The plaintiffs contended that the plastics migrated from the bottle into the water itself. They filed a class action in Illinois state court asserting actions for violations of the Illinois Consumer Fraud statute, common law fraud, and unjust enrichment.  The defendant removed the case to federal court and then moved to dismiss the case. 

The Slowinski decision grapples with what is “spring water” for purposes of FDCA express preemption.  The FDA has minutely defined “spring water” and microscopic bits of microplastics are not mentioned.  As long as the water comes from a natural spring, it’s “spring water.”  Accordingly, the Slowinski court dismissed the complaint on preemption grounds.  But the underlying basis for dismissal is the old grow-up, get-real message we learned back in law school. “No reasonable consumer would think that a bottle of water wasn’t a bottle of water because it contained infinitesimally small amounts of microplastics. No reasonable consumer would think that ‘100% Natural Spring Water’ is a guarantee at the molecular level, except that it contains hydrogen and oxygen playing nicely together.”  More to the point, the “likelihood of a reasonable consumer getting stumped is smaller than the size of a piece of microplastic…. No reasonable consumer would get duped by a failure to make a disclosure on the molecular level.”

Slowinski is a clear case of express preemption under the FDCA. The FDCA forbids states from imposing “any requirement for a food which is the subject of a standard of identity established under section 341 of this title that is not identical to such standard of identity or that is not identical to the requirement of section 343(g).”  The Slowinski court correctly identifies “identical” as the key word.  Since the FDA does not concern itself with microplastics in its definition, the plaintiffs’ suit necessarily is not “identical” to the FDA’s standard.  

The plaintiffs could not get around the FDA definition by claiming that they challenged only the “100% natural” language in the label.  The FDA imposed no molecular level requirements, so the plaintiffs cannot either.  “The existence of microplastics doesn’t mean that the spring water isn’t spring water.”  The plaintiffs are not allowed to rewrite the FDA’s definition of spring water. 

Even aside from preemption, the plaintiffs simply have not set forth a material misrepresentation. Again, there is no misrepresentation that would confuse a reasonable consumer.  “Reasonable consumers don’t buy bottled water and then look for the nearest microscope.”  And in terms of the need to get real, the court points out that “[i]f the existence of microplastics means that a food item isn’t natural, then the word ‘natural’ can’t apply to any food anywhere.  Food companies couldn’t use the word ‘natural’ for anything.”  Now that might be exactly the plaintiff lawyer’s’ point, but it’s a bad point. 

In addition, the Slowinski court held that the plaintiffs had inadequately set forth any fraudulent intent on the part of the defendant, or that the plaintiffs had suffered “any observable economic consequences.”  Finally, the unjust enrichment claim is “a non-starter” because it is not a separate cause of action under Illinois law.  

So none of the plaintiffs’ claims hold water.  Nevertheless, the Slowinski court gave the plaintiffs a chance to amend their complaint. They get the opportunity to go back to the well. We predict they will come back empty. 

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On its face, Osos v. Nuvasive, Inc., 2024 WL 3585092 (E.D. Mich. July 30, 2024), is a fairly routine medical implant product liability lawsuit, involving allegations of metallosis that have already been around the block quite a few times in hip implant cases.  Osos involves a somewhat different device, but the legal principles are no different.

But Osos involves Michigan law, and Michigan (as we first mentioned at the end of last year, and discussed more thoroughly here) only recently repealed a longstanding conclusive presumption of non-defectiveness based on FDA drug approvals.  That presumption, which “functionally foreclosed” most product liability claims against, such products, White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023, 1029 (W.D. Mich. 2008), undoubtedly reduced litigation by Michigan plaintiffs.  See Our “Michigan Diaspora” post.  The repeal will equally undoubtedly cause Michigan prescription medical product litigation to rebound.

Continue Reading Possible Learned Intermediary Showdown in Michigan

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