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South Carolina is a lovely state with mostly lovely weather, though this time of year its appearance on the map looks like the country’s jutted chin daring a hurricane to sock it. South Carolina courts have been known to sock it to defendants, particularly in asbestos cases.    

Luckily, asbestos has nothing to do with today’s case, Britt v. Sorin Grp. Deutschland GmbH, 2023 U.S. Dist. LEXIS 158410 (D.S.C. Sept. 6, 2023).  From the perspective of your friendly neighborhood defense hack, the court’s decision is more good than bad. The defendant medical device manufacturer won all its summary judgment motions, except for punitive damages. The case is frankly a bit weird, because the plaintiff seemed to be claiming that the defendant’s device, which regulates blood temperature during an operation, caused an unusual bacterial infection years after the fact with no intervening problems. 

The case went through the MDL process and was eventually remanded to the District of South Carolina.  The defendant filed a summary judgment motion seeking dismissal of the claims for manufacturing defect, express warranty, implied warranty, negligent misrepresentation, misrepresentation via omission, violation of the South Carolina Unfair Trade Practices Act, and punitive damages. 

Manufacturing Defect

The plaintiff contended that the device was defective because the introduction of water during the manufacturing process contaminated the device, leading to the formation of a biofilm.  But the plaintiff alluded to no evidence that the device was defectively manufactured and did not conform to design specifications.  Rather, this claim was “more appropriately characterized as one for design defect because it alleges a potential design flaw” in the device.  (The complaint included a claim for design defect, but the defendant did not seek summary judgment on that claim.)  This was another instance of a plaintiff trotting out a design defect claim masquerading as a manufacturing defect claim.  It usually does not work.  It did not work here.    

Express Warranty

There was no evidence that the defendant “communicated any affirmation of fact, promise, or description” regarding the device “that became the basis of the bargain” in the sale of the device. The plaintiff relied on certain statements in the device’s Instructions for Use (IFU), but the IFU is a communication to the medical provider, not the patient.  Because the plaintiff presented no evidence that the defendant made any express warranties to the medical provider that extended to the patient-plaintiff as a third-party beneficiary, the express warranty claim was a goner.    

Implied Warranty

Unlike with the express warranty claim, South Carolina law might allow for a third-party beneficiary claim for an implied warranty.  But the manufacturer had conspicuously disclaimed the implied warranties of merchantability and fitness for a particular purpose. There was some squabbling over whether the disclaimer occurred before or after finalization of the purpose, but, in the end, the facts supported enforcement of the disclaimer and dismissal of the implied warranty claim. 

Negligent Misrepresentation

The negligent misrepresentation claim failed here because the defendant dealt only with the hospital, not the plaintiff, and the plaintiff never owned the product.  Nor was there any reliance. Moreover, South Carolina has not extended a negligent misrepresentation claim beyond statements made for pecuniary purposes resulting in pecuniary loss. 

Misrepresentation via Omission

Under South Carolina law, a duty to disclose exists only when there is some sort of fiduciary relationship between the parties.  No such fiduciary relationship (indeed, no direct relationship or communication of any kind) existed between the manufacturer and the plaintiff. Accordingly, the court dismissed the claim of misrepresentation by omission.    

South Carolina Unfair Trade Practices Act

Once again, the absence of any communication between the defendant and the plaintiff doomed the legal claim.  As with the misrepresentation claims, the plaintiff pointed to the omission of a warning.  And, as with the misrepresentation claims, the fact that the plaintiff never purchased the product from the defendant and never relied on the defendant spelled the end of the claim.  

Punitive Damages

Well, you can’t win them all.  Thedefendant did not move on design defect, and the court saw some room for a factual dispute as to whether the defendant’s conduct (presumably in designing the device) was “willful, wanton, or in reckless disregard of the Plaintiff’s rights so as to warrant punitive damages.”  Sigh.  In our opinion, it should be exceedingly hard to make out a claim for punitive damages for a design defect claim.  There is no aspect of alleged lying, as there is with failure to warn or misrepresentation.  Except for the rarest of scenarios, getting the risk-benefit calculation wrong does not seem to involve any bad faith or even recklessness.  But our opinion is not the law in South Carolina or anywhere else, so we’ll just have to swallow this one nasty bit in what is, overall, a fairly tasty opinion. Call it shrimp and grits, with a small side of liver.

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If a court tells you your only non-preempted claim is one based on a theory that your labeling does not comply with the Federal Food, Drug & Cosmetic Act (“FDCA”), it’s probably a good idea for your expert so opine.  Opting instead for expert testimony based on a consumer’s perspective is risky and likely problematic.  So discovered the plaintiff in Gwinn v. Laird Superfood, Inc., 2023 U.S. Dist. LEXIS159513 (S.D.N.Y. Sep. 8, 2023).

Plaintiff brought a putative class action against the manufacturer of powdered creamer products alleging its nutrition labels inaccurately described the serving size.  As noted above, in a prior decision denying defendant’s motion to dismiss, the court made clear that to avoid preemption, plaintiff had to prove a very specific claim.  That is because the FDCA “expressly preempts any requirement for nutrition labeling of food that is not identical to the requirements of the Act.”  Id. at *10.   

The FDCA has very explicit rules for how a manufacturer displays serving size.  A serving size is “an amount customarily consumed” and it must be expressed “in a common household measure that is appropriate to the food.”  Id. at *2.  There are also FDA regulations that state that for a powder, the serving size must contain a “reference amount” of 2 grams.  The “common household measure” must be one that “most closely approximates the reference amount.”  What that means is that the creamer labels would need to say something like, a serving size is “1 tsp. (2 grams)” and provide the number of servings per container.  The rub is that 1 teaspoon is not always exactly the same as 2 grams.  Remember, the FDA says the measure and the reference amount have to be “close,” not exact.

The regulations also state that the “number of servings” per container have to be calculated “according to the reference amount, rather than the household measure.”  So, if it is an 8 ounce package of creamer, that is 227 grams.  According to the FDA, the manufacturer needs to report the number of servings as 114 (227 ÷ 2).  But what if the consumer measures out the creamer and doesn’t come up with 114 teaspoons of powder?  She brings a lawsuit.

Then she hires an expert in metrology, the science of measurement.  Plaintiff provides that expert with one container of each type of creamer at issue (different flavors).  The expert empties each container to get the total weight and to loosen the powder.  Then he attempts to “verify the information on the label in the same manner one would expect of any consumer”—he measures it using a standard household teaspoon.  Id. at *6 (emphasis added).  Then he weighed each teaspoon and found that each held more than 2 grams of the product.  That means that with each serving, the consumer is actually using more than 2 grams causing the total number of servings per container to be less than the amount on the label. 

That brings us back to preemption.  Plaintiff’s claim can only survive if she has evidence that defendant’s label used a different measure than prescribed by the FDA.  In other words, if the label complies with the requirements of the FDCA, plaintiff’s claim must be dismissed.  Id. at *10-11.  Plaintiff’s expert, therefore, must address this question.  He did not. 

The court’s first reason for striking the expert report is simply that it is irrelevant:  the expert’s “consumer measurements have no bearing on whether [defendant] failed to follow the prescribed regulatory scheme.”  Id. at *11.  While consumers don’t have to adhere to FDA regulations in measuring their servings, the manufacturer does.  At best, the expert’s opinion goes to whether FDA’s regulations result in misleading labels for a consumer – but that issue is preempted.  Id. 

Second, the report does not comply with Rule 702’s requirement that an expert adhere to a scientifically reliable methodology.  The expert measured the creamer like a consumer, not in a manner one would expect of an expert metrologist.  One very basic example is the expert did not state whether he “packed or leveled” the product in each teaspoon.  As any home baker knows, there is a drastic difference between a heaping teaspoon of sugar and level teaspoon or firmly packed brown sugar and sifted powder sugar.  If the expert’s report doesn’t have even the type of information you would find in a standard recipe, it is difficult to conclude it applies the necessary scientific rigor for admissibility.

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As a defense lawyer, one grows accustomed to clear judicial days on which the state court can foresee forever.  See Thing v. La Chusa, 48 Cal. 3d 644, 668 (1989).  On those clear judicial days, when the court catches a glimpse of the possibility of harm shimmering off in the distance, one can be assured that an expansion of liability soon will follow.      

Not all state courts are quick to expand tort liability, however.  In Baker v. Croda Inc., __ A.3d __, 2023 Del. LEXIS 282, 2023 WL 5517797 (Aug. 24, 2023), the Supreme Court of Delaware was asked to gaze into the future, and it decided to leave liability tied to an actual injury in the here-and-now.

The Baker opinion did not involve a pharmaceutical or medical device (it involved a chemical, ethylene oxide), but it did involve an issue of particular concern to the blog:  Claims for medical monitoring brought by a class of plaintiffs who have no present injury, but who allege they are at an increased risk of developing cancer in the future.  As a remedy, the plaintiffs requested money in the present, for the “cost of reasonably medically necessary diagnostic testing for the early detection of illness, disease or disease process.”  

In response, Delaware definitively rejected the liability for no-injury medical monitoring claims, for the straightforward reason that:

[A]n increased risk of illness without physical harm is not a cognizable injury under Delaware law. Stated differently, an increased risk of harm only constitutes a cognizable injury once it manifests in a physical disease.

Baker, 2023 WL 5517797 at *2.

The first thing worth pointing out about Baker is that it came to the Supreme Court of Delaware by way of a certified question from the Third Circuit.  Good on the Third Circuit for certifying the question instead of plowing ahead and making an expansive Erie prediction.  But query whether the law actually was unsettled as the Third Circuit seemed to believe.  At least three times before, Delaware had declared that “claims in tort require an actual or imminent injury”—something that doesn’t exist when one has no present injury, but rather just an increased risk of maybe, perhaps experiencing an injury in the future.  See Baker, 2023 WL 5517797 at *3, citing Mergenthaler v. Asbestos Corporation of America, 480 A.2d 647 (Del. 1984) (holding that present physical disease is required to state a claim under Delaware law); Brzoska v. Olson, 668 A.2d 1355 (Del. 1995) (rejecting claims for mental anguish and medical monitoring because “damages for claims of emotional distress or mental anguish … are recoverable only if [an] underlying injury is shown”), and United States v. Anderson, 669 A.2d 73 (Del. 1995) (“requirement of a preceding physical injury prohibits plaintiffs from claiming that exposure to toxic substances, for instance, has created an increased risk of harm not yet manifested in a physical disease”).

Picking that apart a bit more, the Delaware Supreme Court explained that it is “axiomatic that all tort claims require an injury,” and that injury is defined in a way that excludes mere “increased risk” because, in Delaware, an injury in fact must be “actual or imminent, not conjectural or hypothetical.”

Turning to policy issues, the Baker opinion echoed the concerns expressed in the key federal opinion rejecting no-injury medical monitoring, Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424 (1997).  Not unreasonably, both Metro-North and Baker recognized that allowing “traditional, full-blown tort liability” in the absence of an actual injury threatens “unlimited and unpredictable liability” and a “flood” of less important cases that could swamp the claims of those with injuries that do manifest, particularly because exposure to even toxic substances (fortunately) may never result in any harm. 

Both opinions also recognized that there is a competing policy concern, namely the injustice in having “economically disadvantaged persons” bear the cost of paying for their own diagnostic testing.  Baker did so to highlight complexities raised by the prospect of allowing no-injury medical monitoring claims, should Delaware’s General Assembly ever choose to take up legislation allowing such claims.  But to that, we can’t help but wonder why “more litigation” tied to a particular alleged toxic exposure —with all the resulting inefficiencies and transaction costs, yet ultimately limited scope—would be a better solution than making health care that broadly covers medically appropriate preventative care and diagnostic testing more widely available.  But we digress.    

And so we will leave Baker at that. Bexis can add another case to his no-injury medical monitoring 50-state survey.

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Since before the Dobbs decision reversed decades of precedent on reproductive rights, we have been looking at the implications for drug and device manufacturers.  See here and here.  Our posts have, of course, followed the ins and outs of the notorious AHM (or Hippo) litigation as it makes its way up to the Supreme Court for an inevitable merits decision.  See here , here, and here.  We have also been following a challenge in the Southern District of West Virginia to state law effectively banning and criminalizing the use of medications that the FDA has approved specifically for abortion.  In that case, GenBioPro, Inc. v. Sorsaia, the only US manufacturer of (generic) mifepristone contends that a series of West Virginia laws violate both the Supremacy Clause and Commerce Clause.  When the court rejected the defendants’ challenge to the plaintiff’s standing, we were encouraged about the plaintiff’s chances on preemption, noting both the court’s rigor and its rejection of the Northern District of Texas court’s result-driven analysis in AHM.  A week later, in discussing the Supreme Court’s National Pork decision on the dormant commerce clause, we offered:

We find it unlikely, but not impossible, that some state law about medication abortion might still violate Healy and Walsh.  For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

We are sorry to say that our optimism on preemption was misplaced and our prediction on the dormant commerce clause was correct.

Last week, the district court in GenBioPro, Inc. v. Sorsaia, No. 3:23-0058, 2023 U.S. Dist. LEXIS 149195 (S.D.W. Va. Aug. 24, 2023), considered the rest (i.e., not standing) of the defendants’ motions to dismiss.  The first part of the decision provided false hope for the plaintiff.  After recapping the state laws and the regulatory history of mifepristone, the court stated:

The result of [FDA’s] heightened scrutiny and extensive review is a REMS which unambiguously assures the safety of the drug without any additional safeguards from the States.  Defendants have not disputed the safety of mifepristone, nor could they.

Id. at *8.  This came with a declaration that the court did not find the Fifth Circuit’s AHM decision’s “primary determinations to be persuasive.”  Id. at *7 n.8.  The Sorsaia court then rejected the defendants’ argument that the enunciation of the new “major questions doctrine” in West Virginia v. EPA, 142 S. Ct. 2587 (2022), essentially wiped out the possibility of preemption.  We will not dwell on that part, because the argument was weak.  Defendants contended that anything about abortion was a “major question” that had to be decided by Congress rather than FDA and abortion was not mentioned in the FDCA, FDAAA, or other acts governing FDA.  The FDCA “does [not] mention any other specific procedure, device, cosmetic, or medication it instructs the FDA to regulate.”  Id. at *14.  Instead, FDA’s regulation of mifepristone is authorized by numerous provisions, including “FDAAA’s express command that FDA promulgate a REMS for Subpart H-approved drugs (including mifepristone), subject to certain delineated principles, including accessibility.”  Id. at *13.  That was the end of the part we like.

The preemption analysis started off on the wrong foot in the same way many courts have before—misapprehending that there is a broad presumption against preemption.  Citing Levine, the Sorsaia court stated “there is a presumption against preemption, especially in a field traditionally occupied by the States.”  Id. at *17.  Not for implied preemption.  There is such a presumption in field preemption, which was not at issue in either Levine or Sorsaia.  Since the Supreme Court’s decision in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), eight years after Levine, there is no such presumption in express preemption either. Albrecht, which reworked Levine on implied preemption, did not mention any such presumption.  With this non-existent presumption in play and the focus wrongly on Congress’s intent as to mifepristone in particular, Sorsaia rejected both obstacle and conflict preemption.  This rejection also hinged in large part on the characterization that the West Virginia laws merely “restricted” the use of mifepristone, rather than functionally banning and criminalizing the use of an FDA-approved prescription medication for its FDA-approved intended use.

On obstacle preemption, the court analyzed the REMS provisions in FDAAA as “directing the FDA to consider burden and access when promulgating REMS with elements to assure safe use to ensure that the elements themselves would not be unduly burdensome upon patient access.”  Id. at *22 (emphasis in original).  Combined with the fact that Roe was still in effect when FDAAA passed, the Sorsaia court concluded Congress did not intend “for the FDAAA access language to preempt state abortion restrictions which would have been unconstitutional at the time the FDAAA was passed.”  Id. at *23.  This perverse reasoning dictated that “the [state] UCPA and abortion restrictions do not pose an ‘unacceptable obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”  Id. (citing Levine).  “Any additional or incidental burden West Virginia has placed upon patients wishing to obtain mifepristone”—presumably, leaving the state to receive medical care without the threat of felony prosecution—“does not provide an unconstitutional ‘obstacle’ to the FDAAA’s unambiguous directive to FDA.”  Id. at *24.  One state criminalizing the prescription of a medication that FDA has approved for use by prescription throughout the United States does seem like an obvious obstacle to the charge in the FDCA that FDA has sole authority to approve prescription medications.

The analysis of conflict preemption was similarly flawed, as we see it.  Citing Bartlett and Mensing, the Sorsaia court described the issue as “[t]heoretically—regardless of the intent of the FDAAA—the mifepristone REMS could directly conflict with West Virginia’s restrictions, thereby creating a system in which individuals regulated by both federal and state law could not comply with both mandates.”  Id. at *25.  This is a bit backwards, because FDA’s authority and its approval of defendant’s generic mifepristone predated the West Virginia ban and the Supremacy Clause puts the focus on whether state law conflicts with federal law.  As we have stated several times before, once the FDA says “yes,” a state cannot say “no.”  See here, here, and here.  That is about as direct a conflict as we can imagine.  In any event, Sorsaia sidestepped a true conflict analysis by concluding that the manufacturer was “not regulated by the UCPA at all.”  Id. (emphasis in original).  The reasoning was that certain UCPA provisions were directed at “licensed medical professionals,” which did not include a drug manufacturer.  This analysis ignored that another provision of the UCPA discussed earlier in the opinion made it a felon for “any other person [to] induce[] . . . or attempt[] to . . . induce an abortion.”  Id. at *2.  Unless manufacturing, selling, and distributing the only approved abortifacient will never be considered an attempt to induce an abortion, this sidestep should not have worked.  The obvious issue, especially because plaintiff sells a generic drug, is that a ban of an FDA-approved drug conflicts with the FDA’s approval by all conventional reasoning.  The Sorsaia court dropped a confusing footnote on this issue, citing Bartlett and saying it rejected “Defendants’ argument that GenBioPro may simply choose to stop selling mifepristone in West Virginia, and thus avoid any conflict between state and federal law.”  Id. at *26 n.10.  However, the Supreme Court’s treatment of the “stop selling” argument means that a state ban creates a conflict with the federal action of approval and must yield.

There was more.  In rejecting the defendants’ challenge to standing, the court had concluded that the plaintiff could assert the interest of licensed medical professionals in West Virginia who purchased and otherwise planned to distribute its mifepristone.  The court still found no conflict because “the UCPA is a restriction on the incidence of abortion, rather than a state directive in a direct conflict with the logistical REMS regulations.”  Id. at *28.  That bit of contortion was purportedly supported by the Supreme Court’s rejection of preemption in cases about uranium mining (a field preemption analysis where the petitioner did not raise an impossibility argument) and horsemeat (express preemption analysis only).  Id. at *29.  These have little to do with the conflict/impossibility preemption analysis for a drug specifically approved by a federal agency with specific requirements imposed by a REMS.

The Sorsaia court also rejected field preemption and dormant commerce clause challenges to the state law.  We think these were fairly foregone conclusions, so we will not spend time on them.  The interesting part for dormant commerce clause devotees is that the court did a Pike balancing test, the viability of which has been debated since National PorkOne significant aspect of plaintiff’s case was kept alive, though.  West Virginia law prohibits prescribing mifepristone via telemedicine and the current REMS on mifepristone expressly authorizes it.  This is a conflict that the Sorsaia court recognizes:

This conflict between the REMS and the state statute creates the kind of impossibility preemption discussed above—a licensed medical professional prescribing mifepristone could not comply with both the access determination made by FDA and the access determination made by West Virginia as to telehealth.

Id. at *37.  It is incongruous to find a conflict here but not as to the more restrictive West Virginia laws, but it does mean the case is still alive.  Eventually, the case seems likely to get up to the Fourth Circuit, as which time the rejection of broader preemption in this opinion will be examined.  In terms of tea leaves, the Fourth Circuit did reverse a plaintiff’s verdict in Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., 984 F.3d 329 (4th Cir. 2021), because the district court applied Levine to reject implied preemption and then Albrecht came down.  Whether Sorsaia’s reliance on Levine after Albrecht will lead to the same fate remains to be seen.  Of course, what the Supreme court does with AHM in the interim may be determinative.

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Patora v. Vi-Jon, LLC, 2023 U.S. Dist. LEXIS 153421 (S.D.N.Y. Aug. 30, 2023), is a typical express preemption decision resulting in dismissal of a typical consumer protection-based purely economic loss class action against an over the counter (OTC) product.  The plaintiffs, suing on behalf of a putative class, alleged that they purchased an OTC laxative product that contained a bacterial contaminant.  The defendant had recalled the product. The plaintiffs asserted that they became ill as a result of the bacteria, but their claim was not for personal injury, it was for the money they paid for the laxative.  According to the plaintiffs, the laxative label was deficient because it did not list the bacteria as an ingredient, nor did it warn of the possibility of bacterial contamination.  The plaintiffs contended that they, naturally, would not have purchased the product if they knew of the bacterial contamination.  The product was worthless. The plaintiffs wanted their money back.  The complaint set forth causes of action for deceptive acts or practices and false advertising under New York General Business Law.

The defendant filed a motion under Fed. R. Civ. P. 12(b)(6) to dismiss the complaint because the claims were expressly preempted by the Food, Drug and Cosmetic Act, 21 U.S.C. section 301 et seq. (FDCA).  The FDCA contains an express preemption provision for state laws governing OTC drugs, including laxatives.  Under that express preemption provision, no state can enforce any OTC labeling requirement not “identical” to what the FDA requires.  In essence, the plaintiffs were attempting to turn what amounted to manufacturing defect allegations (if the bacteria was in the laxative, it got in by mistake) into a warning claim more amenable to class action status by claiming that a possible contaminant should have been listed as an “ingredient” in the OTC product’s labeling.  We’re tempted to call the claim clever, but it actually isn’t.  We’ve seen it before and it has failed before.  

The FDA promulgated regulations define a drug active “ingredient” as a substance “intended” to furnish pharmacological activity or other direct effect in the diagnosis, mitigation, treatment, or prevention of disease.  A contaminant does not come close to fitting the bill. An inactive ingredient is any other “component,” which, in turn, is “intended” for use in the manufacture of a drug product. Intention, then, is at the heart of the matter.  Some people say that divining anyone’s intention is impossible.  Perhaps you’ve heard something like that with respect to some recent indictments of rather famous figures.  But juries make determinations about intention every day.  Sometimes judges do, too,  Sometimes it is really easy.  That was the case in Patora.  No one suggested that the alleged bacteria was intended to be in the laxative.  Therefore, the bacteria is not an active or inactive ingredient, and federal law does not require that the bacteria appear on the ingredients list.  The plaintiffs’ insistence that the bacteria be listed as an ingredient is not only not “identical” to federal regulations, it is directly contrary to them.
Moreover, to the extent that the plaintiffs’ claim is more about absence of warning as opposed to absence of an ingredient listing, the claim still runs counter to federal law.  OTC products are required to contain warnings included in an applicable OTC monograph.  Not all OTC products are included in a monograph, but the laxative product in question was listed in a 2023 monograph.  That monograph set forth nine specific warnings.  The Patora court read the monograph and concluded that “neither the general OTC requirements for warning labels nor the 2023 monograph laxative-specific requirements for warning labels mandate a warning related to the potential inclusion of any bacteria” – let alone the specific one in this case.  

Since the FDCA does not mandate the disclosure that the plaintiffs were demanding, the plaintiffs’ claims were expressly preempted. The Patora court quoted another case saying that the plaintiffs’ claims are “exactly what the FDCA does not permit.”  Given the obvious express preemption of these contaminant-as-ingredient claims, and given the build-up of precedent on precisely this point, by now these claims by plaintiffs are utterly frivolous.  

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As we’ve discussed before, the United States Supreme Court, in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), sent the presumption against preemption, in express preemption cases anyway, into the dustbin of history.

[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Id. at 125 (citations and quotation marks omitted).

Continue Reading On the Erstwhile Presumption Against Preemption, the Third Circuit Sticks Out Like a Sore Thumb
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We observed oral argument the other day in a case that could have a significant impact on potential liability under California tort law for pharma companies and all other innovators.  In Gilead v. Superior Court, No. A165558 (Cal. Ct. App. First Dist.), a panel of the California Court of Appeal is considering whether a prescription drug manufacturer can be liable in tort not for a product defect, but for negligence in failing to develop a different, allegedly safer product sooner than it actually did.  This is an important case, since a decision in favor of the plaintiffs would create a new “duty to innovate” under which a drug manufacturer could be liable for failing to develop a different drug that, in 20/20 hindsight, might have been better for some patients.  No court has allowed this. 

At issue are life-saving antiretroviral drugs used to treat patients with HIV, and we have written on similar cases involving the same drugs and legal theories before.  See, e.g., here and here.  The defendant in Gilead has developed multiple drugs used to treat or prevent infection with the AIDS virus, including several containing tenofovir disoproxil fumarate (“TDF”) as an active ingredient.  That is the group of drugs that the plaintiffs allegedly used and that allegedly caused harmful side effects.  Keep that in mind.  These plaintiffs are claiming that they used a product and suffered physical harm as a result—i.e., unambiguously product liability claims.

The problem for these plaintiffs is that there is no evidence of a product defect in TDF drugs.  As a result, they are not claiming a defect in design; they are not claiming that the drug warnings were inadequate; they are not claiming that TDF drugs should be withdrawn from the market; and they agree that TDF drugs have benefited and continue to benefit thousands of patients. 

So the plaintiffs pivoted.  The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)— about a year later.  Plaintiffs now claim that TAF has a better safety profile compared to TDF and that the defendant unreasonably (i.e., negligently) paused TAF’s development, thus depriving them of a drug that they say might have avoided their injuries. 

That is how we got to oral argument in the California Court of Appeal.  The trial court denied the company’s motion for summary judgment and ruled that the plaintiffs could pursue a negligence claim based on the purported delay in developing TAF drugs.  On the company’s interlocutory appeal (via a discretionary writ petition), highly skilled advocates for both sides argued their positions to a curious and prepared three-judge panel for more than an hour. 

The defense emphasized at the outset that no court has ever recognized a duty to develop a product more quickly.  One judge quickly challenged counsel on whether the duty here is the ordinary duty to exercise reasonable care to avoid foreseeable injury to others.  Another asked whether this was merely “old world negligence.”  Thus began argument on the origin and limits of tort duties in California.  Yes, the California Civil Code codifies a duty to avoid harm to others, but that does not mean everyone has a duty to avoid everything.  In other words, you can’t just say there is a “duty” and call it a day.  You have to ask what is the duty and what does the duty require?

Counsel argued that the answers depend on public policy, and compelling policy factors weigh against creating this new duty “not to delay development of a safer alternative drug.”  To begin with, the new duty would undermine decades of California product liability law, which centers on proof of a product defect.  Recall that these are unambiguously product liability claims, yet the plaintiffs here are seeking compensation without claiming that the product they used was defective. 

Moreover, a new “duty to innovate” would wreak havoc on product development, not only for prescription drug manufacturers, but throughout the biotech industry and beyond.  Companies make decisions on product development every day, including whether and where to allocate finite resources.  Imagine the chilling effect on innovation if companies had to make those decisions at the risk of being second guessed by juries 20 years down the road.  Finally, the plaintiffs’ proposed duty is unnecessary because product liability law already protects consumers.  The defendant here is not claiming “immunity.”  It was and remains subject to liability under established product liability law, provided the plaintiffs could plead and prove a claim. 

In the end, counsel urged that imposing undue liability would discourage drug development.  In Brown v. Superior Court, 44 Cal. 3d 1049 (1988), the California Supreme Court rejected strict product liability for prescription drugs partly because public policy favors the development and marketing of beneficial new drugs.  That public policy applies here.  By subjecting development decisions to hindsight scrutiny, years after the fact, the plaintiffs’ proposed duty would diminish a manufacturers’ incentive to develop superior products, presumably because any new, “better” product would open the door to claims that it should have been developed earlier and replaced its predecessor sooner.  That is especially true considering that tort inquiries are skewed, i.e., they are decided with reference to one plaintiff, which discloses only the risk side without consideration of the benefits. 

The plaintiffs argued out of the blocks that their negligence claim alleging a failure of reasonable care can and should proceed separate and apart from a product defect claim.  One judge asked whether TDF could be “defective” because there was a better alternative, apparently trying to reconcile the plaintiffs’ allegations with established product liability law.  Plaintiffs, however, did not bite.  Counsel argued that proof of a product defect in TDF would be a specific analysis under California law, but the plaintiffs’ claims have nothing to do with TDF.  As plaintiffs who took the TDF medicines, their claims are about the defendant’s failure to develop more quickly and market faster the later drug, TAF.  (Query how the plaintiffs’ claims could have nothing to do with a defect in TDF, the drug they ingested and that allegedly caused them harm.  But we will come back to that.) 

The duty, according to plaintiffs, is the general duty under the California Civil Code to take reasonable care to avoid causing injury to foreseeable product users.  In the plaintiffs’ view, the defendant has turned duty on its head:  Instead of asking whether the court should create a new duty, the court should accept the Civil Code as the source of a duty of reasonable care and then ask whether public policy should create an exception.  On this point, plaintiffs argued that the California Supreme Court has held that negligence and strict products liability are two separate things. 

One judge expressed surprise that, if plaintiffs’ view is the law, why courts don’t see more cases seeking liability based on product development decisions, using off-road vehicles as an example.  That prompted the plaintiffs to observe that most products are covered by strict products liability.  Prescription drugs are the exception under Brown v. Superior Court, which plaintiffs have to find a way around.  This to us was a significant point, since it basically admits that plaintiffs are trying to evade the limitations that California product liability law places on pharmaceutical design defect claims and the underlying public policy recognized by decades of California precedent. 

Two judges asked whether that means plaintiffs were proposing a duty to innovate, which plaintiffs promptly denied.  This part frankly was confusing, since plaintiffs argued that the defendant had “already innovated” TAF.  But what does that mean?  Sure, the defendant had TAF in development, but there are different stages of innovation, so at what point does the law impose an obligation to bring a product to market, or else face the prospect of tort liability at some undetermined point in the future? 

One judge asked that very question, noting that manufacturers would need to know if and when the law imposes that obligation.  Plaintiffs did not really have an answer, but reverted to their argument that the defendant’s breach of duty was deciding to “delay” development of TAF and that reasonableness is the standard.  Plaintiff closed by noting again, in response to a question, that this is not a product liability case.  The Court of Appeal might accept that, but of course we do not:  The plaintiffs’ core allegation is that they used a product and were harmed as a result.  This is a product liability case. 

On rebuttal, the defense reiterated that plaintiffs are claiming a duty to innovate and that, yes, manufacturers need to know whether and when the law imposes a duty to bring a product to market.  The defense also emphasized the consequences of creating a new duty.  Product development questions are not for juries to decide in hindsight 20 years after the fact.  The California Supreme Court protected incentives to develop and market new and beneficial drugs in Brown v. Superior Court, and the Court of Appeal should not create new duty that would undermine those incentives. 

We have a few observations after reflecting on this oral argument.  First, we agree with the defense that the Court of Appeal can and should confront and decide the core issues of duty presented by this petition.  There was some argument regarding waiver and preservation of issues (which we spared you in our recap).  But, in the end, the advocacy on both sides was top rate, and the panel was engaged.  No court will be better equipped to decide these issues anytime soon. 

Second, no matter the outcome, a petition for review to the California Supreme Court is certain.  The Court of Appeal clearly understands this too, as the panel expressly noted that it was not taking the matter under submission.  That is highly unusually under California procedure.  Because the statutory clock for filing an opinion in California starts ticking upon submission, the Court of Appeal has basically granted itself an unlimited extension of time.  The Presiding Justice said that the Court might request more briefing, or it might take the matter under submission on a later date.  Either way, the Court admonished the parties to “not call us, we’ll call you.”  They know their opinion will be subject to scrutiny and will take their time. 

Third, we could hazard a prediction of the outcome, but could not do so with any certainty.  The panel clearly understood from the beginning that the plaintiffs were asserting a negligence liability theory separate and apart from products liability (“old world negligence”), but the judges also explored the policy considerations more and more as the arguments progressed. 

Fourth, in our biased view, the defense has the better argument on the merits.  The plaintiffs are simply asking for too much.  If their claims really are unrelated to TDF drugs and instead focus only on the company’s purported delay in developing the allegedly safer TAF drugs, then it is difficult to see any limit to “failure to innovate” liability.  Taken to its logical conclusion, any person who might have benefitted from a product not yet on the market could claim that the manufacturer should have set different priorities or moved faster, including patients who received no treatment at all.  Would, for example, the advent of an effective anti-Alzheimer’s drug create claims for the millions currently afflicted by that condition?  That really would take the “product” out of product liability.  We also believe it is obvious that product development decisions should not be subject to 20/20 hindsight and that the Supreme Court’s endorsement of drug innovation in Brown v. Superior Court rings very loudly here.  Finally, the defense hack in us sees no one benefitting from this other than litigants and their lawyers.  A new duty to innovate will not result in more beneficial drugs coming to market, and it would likely have the opposite effect by penalizing companies that chose one development pathway other another, as all manufacturers do. 

We will keep you posted. 

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Today’s case, Ganz v. Grifols Therapeutics LLC, 2023 WL 5437356 (S.D. Fla. 2023), involves a biologic but also speaks to drugs and medical devices. The mixed decision dismisses design-defect and failure-to warn claims but allows manufacturing-defect and failure-to-recall claims to proceed. Although we’ll briefly summarize those rulings, the decision is more interesting for noting three issues that it does not resolve—issues involving preemption, pleading standards, and common-law duties.

The Ganz plaintiff alleges that her husband died after experiencing hypersensitivity to a biologic approved by the FDA. She asserted negligence, design-defect, failure-to-warn, and manufacturing-defect claims against the manufacturer and its holding company.

The court dismissed all claims aginst the holding company for lack of personal jurisdiction. It held that the plaintiff failed to carry her burden of establishing general or specific jurisdiction over the holding company because she offered no evidence to rebut an affidavit stating that the holding company was neither incorporated nor headquartered in the forum state and had not engaged in any claim-related conduct in the state. In short, the court applied the uncontroversial principle that conclusory allegations in a complaint are insufficient to overcome evidence tending to disprove jurisdiction. 2023 WL 5437356 at *4­.

As for the claims asserted against the manufacturer, some were dismissed while others were not.

The court dismissed the design-defect claim as pleaded, holding it impliedly preempted under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), because “[i]t would be impossible for [the manufacturer] to comply with both its state duty to change the composition of [the biologic] and its duty under 21 C.F.R. § 601.12(b)(2) not to make such a change without first obtaining FDA approval.” 2023 WL 5437356 at *7­.

Note, however, the caveat. The court dismissed the design-defect claim “as pleaded.” As construed by the court, the complaint alleged that the biologic approved by the FDA is defective as a matter of state law. So understood, the claim rests on the contention that the manufacturer had a state-law duty to change the biologic’s composition notwithstanding the federal duty to leave the composition unchanged. Bartlett clearly forecloses such a clam.

But what if the plaintiff had instead pleaded a so-called “pre-approval design defect claim” premised on a supposed state-law duty to “have come up with a safer design prior to seeking FDA approval”? 2023 WL 5437356 at *7­. Would such a claim be preempted? Courts are divided. As we discussed here, the Sixth Circuit held such claims preempted in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), while as we discussed here, the Seventh Circuit reached the contrary conclusion in Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020). Yates was number one on our 2015 top-ten list; Kaiser was number three on our 2020 ten-worst list. That circuit split notwithstanding, the Ganz court “decline[d] to address” the issue, finding that the plaintiff had not pleaded a “pre-approval” design-defect claim in the complaint but had instead articulated it for the first time in opposition to the manufacturer’s motion to dismiss. 2023 WL 5437356 at *7­. Similarly, because the manufacturer had not raised it until its opening brief, the court refused to consider the manufacturer’s contention that “Florida products liability law does not permit a pre-approval design defect claim.” Id. at *7 n.6. The court directed the parties to brief the issue thoroughly if the plaintiff files an amended complaint purporting to assert such a claim.

Ganz dismissed the plaintiff’s failure-to-warn claim, but not on preemption grounds. Despite “reject[ing]” the plaintiff’s contention that Wyeth v. Levine, 555 U.S. 555 (2009), “broadly eliminates any preemption defense for a brand-name manufacturer of drugs,” the court concluded that the plaintiff’s failure-to-warn claim was not preempted because, in the court’s view, she adequately alleged the existence of “newly acquired” information that would have permitted the manufacturer to unilaterally change its label without prior FDA approval under the changes-being-effected regulation. 2023 WL 5437356 at *8. According to the court, the plaintiff adequately pleaded the existence of newly acquired information sufficient to justify a labeling change when she alleged that the manufacturer had recalled some lots of the biologic after receiving reports of increased rates of hypersensitivity. While there may be some facial plausibility to the court’s finding, it is hard to reconcile with the court’s simultaneous recognition that, “[i]n conducting a review of the safety of [the biologic] following [the manufacturer’s] voluntary withdrawal of certain lots, the FDA concluded … that the risk of hypersensitivity was adequately described in [the biologic’s] labeling.” Id. at *9. Regardless of that inconsistency, the court dismissed the failure to warn claim on Twombly grounds, holding that the plaintiff failed to plead any facts plausibly suggesting that the biologic’s label—which mentioned the risk of hypersensitivity seventeen times—was in fact inadequate. Id. at *10.

It is worth noting that although Ganz dismissed the failure-to-warn claim on pleading grounds, it sidestepped an interesting pleading issue—namely, whether a plaintiff must plead around preemption to avoid dismissal. On the facts of Ganz, the question would have been whether the plaintiff was required to plead facts plausibly suggesting the existence of newly acquired information that would have allowed the manufacturer to unilaterally change its label without prior FDA approval. Finding that the plaintiff had pleaded sufficient facts in any event, the court did not need to determine whether such facts were required to avoid dismissal on preemption grounds. But the pleading issue is a recurring one in medical-product litigation. Hoping to evade preemption for as long as possible, plaintiffs often argue that preemption is an affirmative defense, that plaintiffs are not required to plead around affirmative defenses, and that claims therefore cannot be dismissed on preemption grounds at the pleading stage. When confronted with such an argument, defense counsel should point to the many cases granting motions to dismiss on preemption grounds and remind courts that plaintiffs are frequently required to plead around affirmative defenses, such as the statute of limitations, to avoid dismissal.

Ganz allowed two claims to proceed:  a manufacturing-defect claim and a failure-to-recall claim.

As happens all too often, the court let the manufacturing-defect claim slide on very thin factual allegations. Although the complaint identified no purported manufacturing defect, the court thought the allegations of a manufacturing defect sufficiently plausible given that the FDA had evaluated the manufacturer’s manufacturing processes when trying to identify the cause of the increased rate of hypersensitive reactions. 2023 WL 5437356 at *12. The court did not offer, and we cannot think of, a reason why one could plausibly infer the existence of a manufacturing defect from the mere fact that the FDA had evaluated the manufacturer’s manufacturing processes.

Finally, the court held that the plaintiff had adequately stated a failure-to-recall claim, rejecting the manufacturer’s contention that the complaint failed to allege facts sufficient to adequately plead causation. But here again the court failed to address an interesting issue—whether there even is a common-law duty to recall a defective product. The court did not reach the question because the manufacturer did not raise it in its opening brief. But as we have noted here, here, and here, courts and the Restatement hold that there is no such duty.

Because it granted the plaintiff leave to amend, the Ganz court might yet have an opportunity to address the questions that it put to the side. Stay tuned.

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Tripolskiy v. Boston Sci. Corp., 2023 U.S. Dist. LEXIS 146689 (C.D. Cal. Aug. 18, 2023), is a case that has much to recommend it. The opinion is clear. It is short.  It is from the district where we once prosecuted criminals amidst the palm trees and smog.  Most important, Tripolskiy is a premarket approval preemption win involving a recalled device. 

The plaintiff sued the manufacturer of an implantable cardioverter defibrillator (ICD) because the battery depleted more quickly than it should have. He was not factually wrong about that. Indeed, the ICD  had been subject to multiple recalls because of the accelerated battery depletion. The plaintiff’s battery started beeping after four years, but the battery life had been represented to be over eight years. 

The manufacturer had mailed recall notices to field representatives and implanting surgeons, but the plaintiff alleged that the defendant had failed to furnish adequate notice to his physician.  The plaintiff filed his complaint in state court, but the defendant removed the case to federal court. Then the defendant got the case dismissed on the grounds of express preemption.  But the dismissal was without prejudice and the plaintiff was allowed to file a first amended complaint. That amended complaint included causes of action for negligence, strict liability, breach of warranty, concealment, misrepresentation, intentional infliction of emotional distress, etc. 

Again, the defendant moved to dismiss. 

 The ICD was a class III medical device, meaning it had gone through the FDA’s “rigorous” premarket approval (PMA) process and meaning that any legal claim seeking to impose any requirement “different from, or in addition to” FDA regulations was expressly preempted. Inevitably, the plaintiff tried to salvage his claim by invoking the dreaded and disdained (at least by us) parallel claim exception. (Aside from the “all deliberate speed” language in Brown v. Board, it’s hard to think of SCOTUS language that has visited more mischief on the law than the Riegel parallel claim ditty.)

The court in Tripolskiy did not buy the plaintiff’s parallel claim argument. Mind you, the court managed to worry us for a bit by reminding us that “[t]he Ninth Circuit is particularly hostile to motions to dismiss under Rule 12(b)(6).” But the SCOTUS requirement under TwIqbal of plausibility and concrete, non-vague factual allegations carried the day, at least for now. 

At the defendant’s request, the court took judicial notice of PMA materials, the recall notice, and the defendant’s public device lookup information from its website. The PMA materials on the FDA website were the sorts of things that courts will pretty much always judicially notice. The defendant’s website was a different matter, or at least it could have been.  The plaintiff did not dispute the judicial notice of the website. In any event, the website was considered as it related to notice, not the truth of the contents. 

The problem with the plaintiff’s amended complaint was that its recitation of FDA regulations was conclusory.  For example, references to failed process controls is so broad and vague as to be meaningless. The plaintiff listed FDA regulations without identifying how exactly the defendant violated them. Importantly, neither a device malfunction nor FDA recalls, by themselves, “create a presumption that FDA requirements have been violated.”  

Did we mention that the plaintiff was acting as his own attorney? As is too often the case, the court in Tripolskiy extended undue mercy to the pro se plaintiff, and permitted him to try again. It was not yet clear to the court that the allegation of other facts could not possibly cure the deficiency. 

Really?  Whither finality?

Still, Tripolskiy is potentially useful to the defense side re judicial notice and the effect of product recalls, so we should be grateful for that. 

In life, finality is not always welcome. 

Over the past year the DDL bloggers have lost loved ones, including a father and a sister, among others. There has been entirely too much death.  It hurts. The law matters a lot to us, but it is nothing compared to the departures of family and friends. 

Last week saw the sudden, untimely death of a lovely man, Mike Henningsen, who had the wisdom to marry into our family. He was kind and generous. He solved problems.  He had a ready grin and a hearty, authentic laugh. He always brought the fun. 

Mike shared our Bruce Springsteen fandom. A couple of years ago, he called to tell us he had tickets for a Springsteen concert in Glendale, Arizona. Good tickets. A five hour plane ride later, we were together in the pit, twenty feet from the Boss, and singing along to “Rosalita.” “I ain’t here on business baby/I’m only here for fun.”  Good times. 

On his current tour, Springsteen has been ending his concerts with “I’ll See You in My Dreams.”  We’d rather see Mike in his 1985 Targa, or at a game, or at the dining room table.  But for now, we’ll have to content ourselves with seeing Mike in our memories and dreams. 

“When all our summers have come to an end

I’ll see you in my dreams 

We’ll meet and live and laugh again

I’ll see you in my dreams 

Yeah, up around the river bend

For death is not the end

And I’ll see you in my dreams.”

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Not too long ago we discussed post-remand Pennsylvania Supreme Court filings in the Mallory personal jurisdiction matter. After reviewing both sides’ filings, we observed: “[U]nless the Pennsylvania Supreme Court in Mallory were to act contrary to the positions of both sides, the DCC issue will be decided promptly, on this appeal.”

Well, that’s exactly what happened. On August 29, the Pennsylvania high court entered this order:

AND NOW, this 29th day of August, 2023, Norfolk Southern Railway Company’s Application to Set a Briefing Schedule on Remand from the U.S. Supreme Court or, Alternatively, to Exercise King’s Bench or Extraordinary Jurisdiction is DENIED. Pursuant to Mallory v. Norfolk Southern Railway Company, 143 S.Ct. 2028 (filed Jun. 27, 2023), the judgment of the Court of Common Pleas of Philadelphia County is REVERSED, and the case is REMANDED to that court for further proceedings.

So no relief will be forthcoming on registration-based general jurisdiction from this quarter. We expect Pennsylvania courts, and particularly the unfortunate jury pools in Philadelphia and Allegheny Counties, to be burdened with large amounts of litigation having nothing whatever to do with the Commonwealth.