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Back in 2020, we encountered Gustafson v. Springfield, Inc., 2020 Pa. Super. Lexis  843 (Pa. Super. Sept. 20, 2020), a decision so bizarre that it reminded us of a Monty Python movie.  That decision “employ[ed] a rationale, at once both paleolithically conservative and pro-plaintiffly radical, that would render any federal “tort reform” statute unconstitutional.”  Gustafson involved a federal statute that preempted most tort litigation involving firearms, the Protection of Lawful Commerce in Arms Act of 2005, 15 U.S.C. §§7901, et seq., (“PLCAA”), and declared that the PLCAA violated the Tenth Amendment.

Since it did not involve prescription medical product liability litigation, the Blog did not follow Gustafson all that closely – our last mention of it was in 2021, noting that en banc reargument had been granted and the singular panel opinion had been withdrawn.  However, the decision that resulted from the reargument was a mess.  Gustafson v. Springfield, Inc., 282 A.3d 739 (Pa. Super. 2022) (en banc), produced no majority and five different opinions from the nine judges.  Moreover, the overall result, which was to reverse the trial court’s dismissal of the suit, was contrary to the majority votes of the individual judges.  How could that be?  Here’s a brief description from a Pennsylvania appellate procedure article Bexis wrote about Gustafson:

The outcome in Gustafson thus differed dramatically from the votes of the nine en banc judges on the merits of the two issues.  The outcome was 5-4 in favor of reversal, as four judges would reverse on constitutional grounds, and one judge would reverse solely on statutory grounds.  On both of the two issues, however, the position advocated by the defendants was in the majority.  Seven justices agreed that, factually, the Arms Act was applicable to the Gustafson plaintiffs’ claims.  By a slimmer margin of 5-4, a majority of the Gustafson judges agreed that the Arms Act was constitutional.

J. Beck, “What Happens When Precedent Splinters? A Look at Gustafson,” Law.com (Nov. 17, 2022).

This bizarre result had one beneficial effect, it virtually forced the Pennsylvania Supreme Court to take the inevitable appeal in order to clean up the mess.  Which it did.  See Gustafson v. Springfield, Inc., 296 A.3d 560 (Pa. 2023) (granting review).

And last month, the Pennsylvania Supreme Court did indeed clean up the mess.  See Gustafson v. Springfield, Inc., 2025 Pa. Lexis 442 (Pa. March 31, 2025).

Continue Reading At Least Pennsylvania Is Not That Completely Different
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Bad fact patterns sometimes make bad law. And sympathetic plaintiffs who experience unfortunate outcomes can lead to decisions that stray from established precedent. Today’s decision from the Northern District of Oklahoma addresses a sad fact pattern, but the court conducted a rigorous Erie analysis and concluded that the Oklahoma Supreme Court would not recognize a duty that pharmacies must fill prescriptions.  Scholl v. Walgreens Specialty Pharm., LLC, 2025 WL 950866 (N.D. Okla. Mar. 28, 2025). 

Continue Reading Federal Court’s Erie Analysis Concludes That Pharmacies Do Not Have a Duty to Fill Prescriptions in Oklahoma
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We often say here that we try not to do the other side’s homework for them or give them ideas about new ways to sue our clients.  When the Supreme Court takes a well-known statute and says, essentially, that it can now be applied in personal injury cases that also have economic damages, we do not think we are letting any felines out of sacs.  For 55 years, the civil RICO statute has been broadly understood not to apply to personal injury claims such as those advanced against the manufacturers of drugs and medical devices.  The Supreme Court seemed pretty clear about this less than nine years ago in RJR Nabisco, Inc. v. European Cmty., 579 U.S. 325, 350 (2016).  More generally, we have detailed how rarely RICO claims have survived motions to dismiss in the context of cases that focused on consumer protection claims against medical product manufacturers.  Admittedly, we have not had to spill much virtual ink on the “antecedent-personal-injury bar” in our posts because the plaintiff lawyers had apparently understood RICO’s authorization of a civil claim for someone “injured in his business or property by reason of a [criminal RICO] violation” as not applying to personal injuries.  In fact, while plaintiff lawyers are not exactly known for restraint in pleading, we have seen many cases where the plaintiffs made clear that they did not have personal injuries in the mix as they sought a route to RICO’s treble damages.  That all appears to have gone out the window because of a strange case with an unusual procedural history and an interesting alignment of justices on the Supreme Court.  We will not belabor why we think the dissenting opinion from Justice Kavanaugh, joined by Chief Justice Roberts and Justice Alito, was more persuasive than the majority decision authored by Justice Barrett, joined by Justices Sotomayor, Kagan, Gorsuch, and Jackson.  (Justice Jackson also wrote a short concurrence, and Justice Thomas wrote a dissent focused on justiciability.)  Instead, we will mostly address where things might go from here in drug and device product liability actions.

We say Medical Marijuana, Inc. v. Horn, 604 U.S. __ (2025) (“MMI”) (discussed at prior stages here and here) is a strange case because the “injury”—we will return to that—was that the plaintiff was fired from his job for refusing to complete a substance abuse program after failing a drug test.  Assuming that there was no other possible reason for the failed drug test beyond his use of a “tincture infused with cannabidiol—more commonly known as CBD” that he apparently thought would not show up on a drug test, plaintiff could have done various things to try to keep his job.  Purchasing another bottle of the CBD tincture for testing for THC and then suing the manufacturer for costing him his job, asserting civil RICO and a range of other theories, was not one of them.  We also find it strange that the decision is silent on whether plaintiff had other possible THC exposures, whether the tincture’s manufacturer claimed it would not show up on a drug test, whether plaintiff researched drug tests—surely, everyone has heard the urban legend about poppy seed bagels—how plaintiff obtained the bottle of the tincture, how it affected him, the FDA’s regulatory treatment of CBD products, and the legality of this product with or without THC in it in New York [where plaintiff bought and used at least some of the product, although that is also not in the decision].  The closest to any of this in the decision are references to defendants advertising the product as “0% THC” and “legal to consume both here in the U.S. and in many countries abroad.”  This set of facts might offer a path to a false advertising claim where the alleged damages are the purchase price (of the first bottle, not the one purchased for testing), but no other physical or economic injury.  Without a physical injury—exposure to a recreational drug substance without more is not a cognizable physical injury anywhere—there is not even an arguable product liability claim.  A violation of the Racketeer Influenced and Corrupt Organizations Act?  Forget about it.  (Pronounce that as you see fit.)  Racketeering would include if the seller of the tincture had extorted plaintiff to pay it to keep quiet that he had purchased and used the product.  We have all seen enough shows about organized crime, fictional or otherwise, to know the difference between being the victim of a racket and believing implausible product claims.

We say the procedural history of MMI was unusual because the district court granted summary judgment on the basis that plaintiff’s loss of employment “‘flow[ed] from, and [was] derivative of, a personal injury he suffered’—the introduction of THC ‘into his system through the ingestion of Dixie X.’”  Other than THC ingestion not being a personal injury and plaintiff losing his job for an intervening decision he made, we understand this as a predicate for the correct conclusion that civil RICO provided for damages for injuries to business and property but not for physical injuries.  On appeal, the Second Circuit went a different route.  It concluded that plaintiff had been “injured in his business” by losing his job.  That would have been sufficient to reverse.  Without deciding if plaintiff’s case was based on a personal injury—something he denied—the Second Circuit also went ahead and found that, while RICO “implicitly excludes recovery for personal injuries,” it nonetheless allows for recovery of business losses that are causally connected to a prior personal injury.  Then the Supreme Court’s majority decision considered only the issue of “whether civil RICO bars recovery for all business or property harms that derive from a personal injury.”  That is a strange question to resolve in a case where plaintiff did not claim to have suffered a personal injury and did not have a personal injury that would have been cognizable under state law.  Even setting aside TwIqbal and the heightened pleading required for the fraud-based allegations in plaintiff’s complaint, the fact that the appeal was from summary judgment for the defendant should have obviated the need for the majority decision to rely on so many assumptions about the facts and allegations in the case.  The dissenting opinions spelled out a number of reasons why this history weighed against the decision the majority reached.  As the Thomas dissent stated, “I would not decide whether losses flowing from person injuries are injuries to business of property in a case where no one know whether the plaintiff suffered a personal injury.”

We trust that others will delve more deeply into the competing opinions within MMI, but we will point out some of what principal dissent said that may have implications for drug and device product liability litigation.  The legislative history on RICO made clear that it was “an act designed to prevent ‘known mobsters’ from infiltrating legitimate businesses.”  It was certainly not intended to federalize business torts, let alone personal injury and product liability claims.  See, e.g., Midwest Grinding Co. v. Spitz, 976 F.2d 1016, 1025 (7th Cir. 1992) (“RICO has not federalized every state common-law cause of action available to remedy business deals gone sour.”); Calcasieu Marine Nat. Bank v. Grant, 943 F.2d 1453, 1463 (5th Cir. 1991) (“[A]lthough Congress wrote RICO in broad, sweeping terms it did not intend to extend RICO to every fraudulent commercial transaction.”).  As the Kavanaugh dissent put it:

If the rule were otherwise, as plaintiff Horn advocates here, RICO would federalize many traditional personal-injury tort suits.  When enacting civil RICO in 1970, Congress did not purport to usher in such a massive change to the American tort system . . . . On the contrary, it excluded personal-injury suits.  And it is not remotely plausible to conclude that Congress excluded personal-injury suits under RICO and then turned around and somehow implicitly authorized most personal-injury suits under RICO.

This reminds us of the confusion many courts seem to have when it comes to the presumption against preemption, which applies in the context of field preemption but not to express or implied preemption.  To comply with constitutional principles, federalizing an area that was traditionally the subject of state law needs to be the result of clear congressional intent.  Even though the majority decision in MMI expanded RICO without much support from the statute’s text or legislative history, we are curious whether the narrow purpose of RICO and its particular requirements will prevent a sea change when it comes to product liability cases against drug and device manufacturers.

The following is certainly not intended to be comprehensive, let alone from self-described experts in all things RICO.  There are many fine treatises and other sources out there.  Instead, for the questions we pose of how hard will it be for plaintiff lawyers to add treble-damages RICO claims to their complaints about allegedly defective drugs and devices and how hard will it be to beat those claims, we highlight a few issues.  First, standing is still a thing.  For a “regular” product liability case where plaintiff actually claims a direct physical injury from the use of the product, there tends not be much of a fight over standing.  Expansion into quasi-injuries to get to RICO, as with a class action, may lead to standing issues.  Second, RICO defendants are supposed to be part of an “enterprise,” and a parent company and its own subsidiary are not an enterprise.  So, in a typical case with the plaintiff using a specific company’s device or drug, it should be hard to find sufficiently separate defendants to paint an enterprise.  Although we have seen claims based on the idea that competing drug companies or drug companies and distributors conspire together to create a market or suppress a purported risk, actual factual allegations to support an actual enterprise should be harder to muster.  Third, for a civil statute, RICO requires a high level of intent:  actual knowledge of the criminality of the activities of the enterprise.  Knowledge can be alleged generally under Fed. R. Civ. P. 9(b) or this would be a tougher requirement at the pleadings stage.

Fourth, the core of RICO is that there have to be at least two predicate acts of racketeering activity sufficient to create a pattern of criminal activity by the enterprise.  The statute includes a list of crimes traditionally associated with organized crime, such as extortion and kidnapping, but also broader categories such as mail and wire fraud.  This should present something of a hurdle in the context of a product liability claim against a medical product manufacturer.  We have seen where a drug company’s alleged off-label promotion and kickbacks to physicians were rejected as RICO predicates.  This is where the purpose of the statute should continue to play a role in precluding basic product liability allegations like the inclusion of an inadequate warning on a product label or a webpage from being seen as RICO predicates.

Last, the Court in MMI emphasized that its expansion of the kind of injuries that can lead to civil liability under RICO would be limited by the purportedly stringent requirement of “some direct relation between the injury asserted and the injurious conduct alleged.”  That may prove to be the case, but MMI is itself a case with an admittedly indirect causation theory and it got to the Supreme Court.  This is hardly encouraging for potential RICO civil defendants.  Winning a motion to dismiss or even summary judgment on causation can be a tough sell, and courts are quite variable in distinguishing between direct and indirect relationships.  MMI also cautioned:

“business” may not encompass every aspect of employment, and “property” may not include every penny in the plaintiff’s pocketbook.  Accordingly, not every monetary harm—be it lost wages, medical expenses, or otherwise—necessarily implicates RICO.

Again, we do hope that recognizing the original purpose of RICO will help courts to limit which alleged indirect economic injuries count for RICO.  However, the MMI decision provides no bright lines for what does not count.  Given that the plaintiff in MMI did not even have a cognizable physical injury, we have reason to suspect that the lack of bright lines will not be so good for the defendants.

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These days there are two topics that dominate legal conferences, presentations, and CLEs: artificial intelligence (AI) and Loper Bright.  You will doubtless see us frequently bloviate about the former, but today’s case – American Clinical Laboratory Ass’n v. Food and Drug Administration, 2025 U.S. Dist. LEXIS 59869, 2025 WL 964236 (E.D. Tex. March 31, 2025 – is about the latter.  In fact, American Clinical is the first FDA-specific application of Loper Bright.  Spoiler alert: the FDA lost.  

The lawsuit was brought by various plaintiffs, including laboratory associations, challenging an FDA final rule that would regulate laboratory testing as medical devices.  (The court had no difficulty holding that these plaintiffs had standing to challenge the FDA’s proposed rule because compliance would cost them plenty.) The plaintiffs argued that the final rule exceeded the FDA’s authority, and that it must be vacated under the Administrative Procedure Act.  The parties filed cross motions for summary judgment. 

We have heard a lot lately about the text-history-tradition method of constitutional and statutory interpretation.  In American Clinical, the court framed its analysis in terms of “text, structure, and history.”  The “tradition” component has always puzzled us a bit, and we are not sure how “structure” differs from text, but the American Clinical court’s approach ends up being fairly easy to follow.  

The court starts, as most do these days, with the text. Put simply, the court held that it could not stretch the statutory definition of “medical device” to include laboratory-developed tests.  The Food, Drug, and Cosmetic Act (FDCA) defines “device” as a “instrument, implement, machine, contrivance, implant, in vitro, or other similar related article, including any component, part, or accessory” that diagnoses or treats disease. By contrast, the lab tests at issue here constituted professional medical care, not the sort of “tangible, physical products” that the statute – applying “ordinary, contemporary, common meaning” – includes as medical devices.  Moreover – and maybe this is a “structure” point – several of the FDCA’s device regulations can be “understood to apply only to manufactured products.”

The history at issue involved FDA’s prior positions being inconsistent.  The court observed that “[a]lthough FDA’s view of its authority to regulate laboratory-developed test services as devices has been a moving target for decades, the relevant statutory framework has not changed since 1988.” The FDA’s inconsistency is normal – after all, new presidents mean new FDA people and policies – and was one of the things driving SCOTUS in Loper Bright to inter Chevron deference.  

Congress passed statutes regarding medical devices in 1938 and 1976, but the FDA did not endeavor to regulate laboratory services until 1992, and even then the FDA’s moves amounted to wavering gestures, some of which “were not well received by Congress.”  (But what did Congress actually do to set the FDA straight? Not much. Par for the course, right?  For a while now, Congress has been more performative than functional. The failure of Congress to do its job is part of the Chevron-Loper Bright story.)

After years of vague mutterings about regulating lab tests as devices, the FDA took concrete steps in 2023 when it announced “its intent to move forward with regulating virtually all laboratory-developed test services as medical devices.”  The “FDA acknowledged that the costs of the proposed rule would be significant.”  It also recognized that the rule would “impose major burdens on laboratories.” 

But the FDA’s effort to regulate lab services as devices ignored the Congressional assignment of oversight of such tests to a different agency (the Centers for Medicare and Medicaid Services) governed by a different statute (the Clinical Laboratory Improvement Act of 1967 (CLIA), which was expanded/amended in 1988). The sequence of legislative enactments reflected that “Congress viewed (1) ensuring medical device safety and effectiveness, and (2) ensuring laboratory-testing accuracy, as distinct problems requiring different regulatory solutions.”  And, after all, Congessional intent, rather than agency aspirations, is what matters when it comes to statutory interpretation.

When it issued its final rule in 2024, the FDA stated that the FDCA “has always classified laboratory test services as medical devices and that the entire history of the medical device requirements, FDA has declined to apply them to laboratory-developed tests simply as a matter of ‘enforcement discretion.’”

Pre Loper Bright, a court applying Chevron deference might well have felt constrained to adopt the FDA’s interpretation and assented to the assertion of regulatory power over lab tests. But Loper Bright is the new sheriff in town, and Chevron is on Boot Hill. Thus, the court in American Clinical concluded that the FDA could not rely on non-reviewable “enforcement discretion” to pound the square peg of therapeutic tests conducted by medical professionals into the round hole of medical device manufacturing requirements. The FDA’s “creative attempt to expand its jurisdiction under the FDCA” failed because it had no authority to expand the definition of “device,” and it contravened “the FDCA’s limits on FDA’s jurisdiction.”  Neither the CLIA’s “statutory text nor its legislative history make any reference to FDA’s allegedly preexisting authority to regulate laboratory-developed test services as ‘devices.’”

Under Fifth Circuit precedent, district courts should generally “nullify and revoke” illegal agency action. The American Clinical court concluded that, in light of the profound compliance burdens that the FDA’s proposed rule would have visited upon labs, the rule had to be vacated. The case was remanded to the FDA for “further consideration in light of this opinion.”  

As a practical matter, decisions such as American Clinical, which apply Loper Bright to curtail FDA authority, might not matter all that much in this moment. The current FDA, which seems to be, er, retrenching, does not appear to have the resources to expand into anything new.  We almost said that the current FDA also does not appear to have the ambitions to expand into anything new, but who can really say? Let’s face it: the executive branch is now through the looking glass.  Any talk about abench inconsistency right now sounds like a comical understatement. American Clinical reminds us that the judiciary – the “least dangerous branch” – appears to be the one branch of government that actually does its job with more logic than lunacy.  

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By their very nature, prescription only medical devices—particularly those that require surgical implantation—are complex products, the design and manufacture of which are not lay person knowledge. So, if you are going to claim such a device malfunctioned, you are going to have to prove it with expert evidence.  This is a well-known legal concept.  Yet, for some reason the plaintiff (not pro se) in Sundaramurthy v. Abbot Vascular, Inc., 2025 U.S. Dist. LEXIS 64361 (D. Mass. Mar. 31, 2025), after having all his claims except manufacturing defect dismissed on preemption grounds, failed to proffer expert evidence that such a defect existed in the stent graft implanted during his cardiac surgery.

Rather, in the first instance, plaintiff seemed content to rely on a malfunction theory to prove his case.  The stent graft balloon could not be retracted therefore it did not “perform as intended” therefore it was defectively manufactured.  But the leaps between each step in that equation were far too wide for the court.  To prove a manufacturing defect claim, plaintiff has to show that a manufacturing error caused the particular product at issue to be defective and that the defect was caused by the manufacturer and not some intermediary after the product left the manufacturer’s custody and control.  Id. at *17-18.  The law in the First Circuit, and beyond, is that “expert testimony is required when the nature of the defect . . . and its causal relation to the accident [are] complex.” Id. at *18.  The expert evidence rule exists so that when manufacturing processes are sufficiently complex so as to be outside the scope of “general, lay knowledge,” the jury is not left to “conduct guesswork.”  Id. at *18-19.  That is why Massachusetts courts have not required expert evidence to prove a manufacturing defect in a case involving a sandal but have required expert evidence where the product at issue was a 1964 Pontiac windshield or an epidural catheter.  Id. at *19-20.  Stent grafts are clearly in the latter category.  Indeed, courts have required expert evidence in cases involving Class I and Class II medical devices.  Defendants’ stent graft is a Class III medical device, meaning it was subject to greater FDA scrutiny placing it well beyond a consumer product—like a shoe—on the complexity scale.

Plaintiff’s surgeon testified that the stent graft had certain known risks, such as becoming stuck, the balloon not inflating or not deflating, and that it could puncture an artery wall.  Id. at *8. The fact that one or more of these risks occurred in plaintiff’s surgery is not evidence that the product deviated from its intended design or was defectively manufactured.  Not only would the lay persons on the jury need to understand the manufacturing processes for the stent graft, but also the unique medical circumstances under which the device was employed to be able to determine if plaintiff’s injuries were caused by a defect.  Knowledge that no ordinary juror is expected to have.

Apparently seeing the writing on the wall, plaintiff made an eleventh-hour attempt to recast his claim under a res ipsa loquitur theory.  He advanced this theory for the first time in response to defendant’s motion for summary judgment.  The argument was too late. But more importantly, even if allowed, the court cited multiple cases involving Class III medical devices where res ipsa loquitur was insufficient to survive summary judgment.  Id. at *26.  A Class III medical device simply cannot speak for itself.  It needs an expert to do that.   Summary judgment granted for defendant.

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Plaintiffs often like to sue in New Jersey, but that does not mean they always get what they want.  The California plaintiffs in Serrano v. Campbell Soup Co. sued a beverage company in New Jersey, but the court rejected their New Jersey law claims and left them with only one California claim—and even then, only barely.  No. 24-cv-4660, 2025 U.S. Dist. LEXIS 57128 (D.N.J. Mar. 27, 2025).  Along the way, the court held that plaintiffs who were harmed in California had no standing to sue under other states’ laws, and most of the California claims went away because the product labeling was not the least bit deceptive.

In Serrano, the plaintiffs alleged that they purchased a beverage called “V8 Splash” at stores in California.  These plaintiffs, however, wanted drinks with only natural ingredients, so they claimed that they would not have purchased the drinks had they known the product had artificial flavors.  Here’s the rub:  The product label did not say “all natural,” “100% natural,” “no artificial flavor,” or anything of the sort.  Instead, the front of the container somewhat clinically described the berry-flavored version as “A Berry Flavored Juice Beverage with a 5% Juice Blend From Concentrate and Other Natural Flavors.”  Id. at *3. 

Does that sound like “all natural” to you?  We did not think so.  And for consumers for whom it was not entirely clear, they could just turn the bottle and read the ingredients, which were listed on the back in black and white. 

The court held first that these California-resident plaintiffs had standing to sue, but only under California law.  They alleged a cognizable injury:  They claimed that they would not have purchased the product or would have paid less had they known it contained artificial flavoring—a so-called “price premium” theory.  That might seem imprecise, but the plaintiffs were not required to allege the exact value of their economic injury.  The needed to allege only “some specific, identifiable trifle of injury.”  Id. at *22. 

The plaintiffs did not, however, have standing to assert state-law claims from states where they did not reside and in which they did not suffer an injury.  Article III requires an “injury in fact,” and these plaintiffs did not allege the impairment of any interest protected under the relevant states’ laws.  Importantly, the court also did not see any point in waiting until the class certification stage to determine standing.  The plaintiffs argued that whether a plaintiff can bring a class action under multiple states’ laws was a question of predominance under Rule 23, but the court saw “no practical benefit to waiting.”  Id. at *29.  That’s big, since all too many class action decisions fall for the other side’s blandishments to kick the can down the road,

Even if the plaintiffs did have standing to sue under New Jersey law, that state’s choice-of-law rules cut them off.  The plaintiffs allegedly received and relied on the supposed misrepresentations in California, where they bought V8 Splash, but they alleged that the defendant made its labeling and marketing decisions in New Jersey.  Under the circumstances, California had the most significant relationship with the dispute, mainly because that is where the plaintiffs allegedly experienced financial losses. 

So California law applies, which leads to our favorite part of the order.  The court ruled that these plaintiff did not allege that the V8 Splash label was likely to deceive reasonable consumers.  A claimed labeling violation without more does not equal deception.  Moreover, we have commented before that a “reasonable consumer” is neither “any conceivable consumer” nor the “most gullible consumer.”  The standard is reasonableness.  The court in Serrano explained it this way: 

[A] mere possibility that the label “might conceivably be misunderstood by some few consumers viewing it in an unreasonable manner” is not enough.  A reasonable consumer “is neither the most vigilant and suspicious of advertising claims nor the most unwary and unsophisticated, but instead is the ordinary consumer within the target population.” 

Id. at *54 (citations omitted).  The label here lacked any representation—express or implied—that V8 Splash contained no artificial flavors.  Thus, neither the label’s text nor its pretty pictures of fruits and vegetables would dupe a reasonable consumer into believing that the beverage contained nothing but natural ingredients.  “The reasonable consumer does not leave his or her common sense at the grocery aisle.”  Id. at *64. 

In the end, these plaintiffs held onto one claim—that the defendant allegedly had engaged in an “unlawful” business practice under California’s Unfair Competition Law because they alleged that the product label did not disclose artificial malic acid as an ingredient.  Under federal and California law, if a drink contains an artificial flavor that “simulates, resembles, or reinforces the characterizing flavor” of the drink, the product has to be labeled “artificial” or “artificially flavored.”  Because the plaintiffs alleged that defendant added malic acid as an artificial flavor, their claim survived.  The label, by the way, did disclose malic acid as an ingredient, but did not say whether it was artificial or why it was added.  The court therefore ordered expedited discovery on (1) whether the malic acid was artificial (malic acid can be natural, too) and (2) whether it provided flavor.  Cut to the chase.  We are on board for that.  

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Late last year, we discussed the dismissal of three purported California no-injury class actions alleging that certain over the counter (“OTC”) acne medicines were contaminated with carcinogenic benzene.  That post also commented:

By the way, guess who says they found the benzene in the products?  It was that good, old “independent” lab, Valisure −  which proceeded to file a citizen’s petition with the FDA seeking action against [these] products.  Sound familiar?

Last month, the FDA responded to the petition.  The agency was not impressed.  Its own testing – contrary to Valisure’s overblown claims in its petition (“detected high levels of benzene . . . in many specific batches”) found practically nothing to be concerned about.  It tested “95 acne products containing benzoyl peroxide for possible benzene contamination,” and “more than 90% of tested products had undetectable or extremely low levels of benzene.”  FDA, Statement ¶1 (March 11, 2025). THe FDA initiated a “limited number of voluntary recalls” due to “findings show[ing] a small number of products with elevated levels of benzene contamination.” Id.  Only six of 95 products were recalled, and even then, only specified lot numbers.  FDA Statement ¶7.

Continue Reading It’s About Time – FDA Calls Foul on Valisure
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Today’s guest post is from Reed Smith’s Matt Jacobson. He addresses the latest and greatest result from litigation that has been generating favorable decisions nationwide applying various states’ so-called “blood shield” statutes (practically every state has one) that declare the use of human cells or tissue in medical treatment to be services rather than products, which has the effect of limiting liability to negligence. As always our guest posters deserve 100% of the credit (and any blame) for their work.

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Milovich v. Aziyo Biologics, Inc., No. 1:24-cv-01208-CL, 2025 U.S. Dist. LEXIS 50935 (D. Or. Feb. 24, 2025), involves Oregon’s human blood and tissue shield statute.  The Drug & Device Law Blog has written about similar cases before, but this one might be the best.  Blood shield laws have been around for over 60 years.  They sound like something that Dracula should fear, along with a knife through the heart, the sun, holy objects, and garlic.  But they are not something that should scare anyone who manufactures blood or tissue based products.  While states have different statutory language, the gist of blood shield laws is that blood transfusions and transplants are a service and not a sale (Dracula would agree he is performing a service), thus barring claims for breach of warranty and strict liability.

Continue Reading Guest Post – The Sun Is Not Setting on Oregon’s Blood Shield Statute
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The recent case of Happel v. Guilford County Bd. of Educ., 2025 N.C. LEXIS 191, 2025 WL 879618 (N.C. March 21, 2005), will probably provoke a political debate, but that is not why your friendly neighborhood DDL blog has it up for discussion today.  In Happel, the North Carolina Supreme Court created an exception to the Public Readiness and Emergency Preparedness (PREP) Act , 42 U.S.C. section 247d-6d preemption for a state constitutional claim against governmental actors who allegedly “forcibly vaccinated a child without his or his parent’s consent.” 

The plaintiffs in the case were a 14 year old high school football player and his mother.  After the school spotted a cluster of Covid-19 cases among the football team, it suspended all team activities and required players to undergo testing and to be “cleared by a public health professional” before returning to practice.  The player showed up a clinic for what he thought would be only testing.  Instead, personnel at the clinic wanted to vaccinate the player.  The player did not consent.  The clinic attempted to contact the player’s mother to secure her consent, but could not reach her.  Then – and here is where the facts get ugly – “[i]gnoring additional protests from [the player] himself, the workers forcibly injected him with the first dose” of a Covid vaccine.  The player and his mother later sued the school board and medical personnel for battery and for constitutional violations. 

Notably, the Happel case did not involve a vaccine mandate. Rather, consent was supposed to be a prerequisite to administration of the vaccine. It just did not happen that way in this case. Have you heard the saying that hard cases make bad law? Sometimes easy ones do, too. 

The defendants relied on the PREP Act to immunize them from liability.  We’ve written about PREP Act immunity several times before, including here and here.  The PREP Act confers broad protections  for certain “covered persons” during public health emergencies, rendering them “immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”  To effectuate this purpose, the PREP Act expressly overrides or preempts any conflicting state laws.  The Secretary of Health and Human services had issued a declaration identifying the Covid-19 outbreak as a public health emergency, thereby activating the PREP Act’s immunity provision.

The defendants in Happel argued that they were “covered persons” applying countermeasures, and that they should therefore be immune from the plaintiffs’ lawsuit.  The trial court agreed with the defendants’ arguments about the PREP Act and dismissed the suit.  The Court of Appeals unanimously affirmed.   

But the North Carolina Supreme Court, exercising de novo review, reversed.  An early hint of that outcome is supplied by the majority opinion’s start to the Background and Procedural History section:  “During the Covid-19 pandemic, ‘we may have experienced the greatest intrusions on civil liberties in the peacetime history of this country.’” (quoting from Arizona v. Mayorkas, 143 S. Ct. 1312, 1314 (2023)(Gorsuch, J.)).  Er, okay. 

The opinion goes on to recognize PREP Act preemption of all state-law tort claims, but also holds that “tort injuries are not constitutional violations.”  That means that the battery claim was preempted.  But the constitutional claim was another matter.  The North Carolina Supreme Court held that fundamental rights under the state constitution were in play.  Specifically, the court was concerned about the mother’s “parental right to control the upbringing of her son and plaintiffs’ shared right to [the son’s] bodily autonomy.”  The North Carolina Suoreme Court recognized both rights under North Carolina law, which is hardly a surprising result  

The majority decision held that the PREP Act preemption did not bar the constitutional claims. Remember how the preemption provision reaches “all claims for loss caused by, arising out of, or relating to, or resulting from, the administration to or the use by an individual of a covered countermeasure.”  The court rejected a “literalist interpretation” of that clause, which would seem to favor preemption.  Instead, the court reasoned that the state constitutional claims were not “claims for loss.”  To our eyes, constitutional deprivations look like species of loss, but the North Carolina Supreme Court saw things differently. It saw “loss” as a “measurable and compensable type ordinarily associated with tort law.”  The court saw tort law as protecting citizens from each other, while constitutional law protects citizens from the state.  So goodbye battery claim, but the constitutional claims get to stick around. 

With the caveat that the authors of this blog are usually pro-preemption, we think the majority’s preemption analysis is off the mark because it applies a presumption against preemption in opposition to the express preemption of the PREP Act.  The analysis also mixes in various implied preemption cases.  None of that analysis dislodges the simple fact that the PREP Act preemption clauses do not limit it to “tort” or other particular types of action. The court calls the PREP Act “ambiguous” as to whether it extends to “unconstitutional conduct.”  The court seizes hold of such purported ambiguity in declining to preempt – or “tamper with” – “state family law.”  

In rejecting the defendants “literalist interpretation” – and whatever happened to Justice Kagan’s conclusion that we are all textualists now? – the majority goes through a series of contortions (the dissent describes them as “dizzying inversions”) to poke a hole in the Act’s broad preemption clause. 

None of this is necessary, however, as the scope of preemption is determined by the scope of the HHS emergency declaration, and that declaration provided that “liability immunity is afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means.” 

While the dissent has the better of the preemption issues, the “voluntary means” language of the declaration would seem to control the ultimate outcome, at least at this stage where the factual allegations are assumed to be true.  If courts are wise to avoid constitutional issues whenever possible, the North Carolina Supreme Court might have strayed a bit here.  With the Happel opinion and its blessing (for now) of a lawsuit against administration of the Covid-19 vaccine, the court certainly made news. The niceties of preemption analysis are worthy of debate.  But somehow, we suspect that the social media characterizations of the opinion will be on a less rarefied level. 

Photo of Michelle Yeary

This post is from the non-Reed Smith side of the blog.

We live in a “producer-pays” world.  Our discovery system gives plaintiffs a windfall by allowing them to demand production of millions of dollars’ worth of documents and data and to impose those costs almost entirely on defendants.  Now think about that in MDLs.   Plaintiffs who have no incentive to be reasonable tend to ask for the sun, the moon, and the stars.  MDL courts faced with a few hundred cases thrown together tend to view the scope of permissible discovery through a rather broad lens. That leads to a perfect storm for defendants.  Which is why the recent decision in the In re Allergan Biocell Textured Breast Implants Products Liability Litigation, 2025 U.S. Dist. LEXIS 55497 (D.N.J. Mar. 21, 2025), placing some of the burden back on plaintiffs caught our attention.

Plaintiffs demanded production of all manufacturing records for every biocell implant from 1990 to the present—over thirty years-worth of data amounting to over 4 million pages of records.  Even after the court limited the discovery to only active MDL plaintiffs and named class representatives who had provided a correct serial number, the burden on defendant was still extremely onerous given that all of the records were only in hard copy stored in Costa Rica and each manufacturing batch record (“MBR”) was made up of several parts that were not stored together.  Defendant made several proposals to try to reduce the burden.  First, it asked plaintiffs to review a set of exemplar MBRs to see if there were any parts that could be omitted from production.  Plaintiffs insisted they needed every element of the MBRs.  Next, defendant offered to permit an onsite inspection of the records, which would include detailed instructions from defendant on how plaintiffs could find the records they wanted.  That offer was also refused.  Finally, defendant offered to produce the records without assembling them into individual MBRs, but rather to produce them how they are kept in the ordinary course of business.  Defendant acknowledged that doing it this way would be less time consuming but would be an over-production that would be very expensive and for which they would seek cost-shifting.  With all of that information, plaintiffs welcomed defendant’s over-production. 

Plaintiffs could hardly claim surprise when defendant went forward with its motion to shift or at least split the costs of producing the MBRs which cost over $700,000 to scan.  Defendant argued that those costs were avoidable because it had offered plaintiffs access to the records for inspection and copying pursuant to Federal Rule of Civil Procedure 34(b).  Or, alternatively, that the pursuant to Rule 26(c) the costs were an undue burden because only 1.1% of the production related to a device implanted in an MDL plaintiff.   In opposition, plaintiffs argued that inspection would have been “futile” because of defendant’s “disorganized recordkeeping,” and that shifting costs would have a “chilling effect” on future discovery. 

But really that is the whole point.  Cost-shifting should have a chilling effect.  It should make plaintiffs think twice about whether they really need the sun, the moon, and the stars when just the stars will do.  It should make plaintiffs think about whether they need every document or just exemplars.  It should make plaintiffs think about whether it is better to compromise.  It forces plaintiffs to have some skin in the game.

Which is what both the Special Master and the district court judge concluded in In re Allergan Biocell.  Defendant fully complied with Rule 34 by providing plaintiffs an opportunity to inspect the records, participating in detailed meet and confers about how the documents are organized, creating indices to help guide plaintiffs review of the documents, and providing exemplar documents for plaintiffs to review in advance of any inspection.  Id. at *507.  It was plaintiffs’ refusal to conduct an inspection or otherwise limit the production request in a meaningful way that caused defendant to incur the high costs—which defendant repeatedly warned of. Id. at *508.   

Plaintiffs’ continued request for complete MBRs led to a fork in the road. Plaintiffs were given a choice between waiting for [defendant] to assemble the records or getting access to all the documents quickly, without reorganizing by [defendant], and they chose the latter.

Id. at 526.  Moreover, defendant not only offered to allow onsite inspection, but also to provide “a means of reasonably facilitating that search.”  Id. at *528.  But when asked if they wanted “every piece of paper in the box” regardless of whether every piece related to a plaintiff, plaintiffs said “Yes.”  Id. at *529.  Sun, moon, and stars.  Maybe if they have to pay for the 99% of the documents that were completely irrelevant, next time plaintiffs will actually review the sample set and make a reasoned choice to only ask for what they need—or what they can afford. 

And that was not the only discovery dispute.  Plaintiffs also sought a corporate witness deposition on defendant’s document retention and preservation.  That’s discovery on discovery which is not permitted absent a showing of a “specific discovery deficiency.”  Plaintiff’s deposition notice also sought production of litigation hold notices and related information that is protected by attorney-client privilege that is only trumped by a showing of spoliation.  The only showing plaintiffs could make is that defendant did not produce custodial documents for five c-suite executives who had left the company more than 20 years earlier.   That only got them permission to inquire about the dates and implementation of the litigation holds, “but not the litigation holds themselves” and they could not ask about litigation holds unconnected to the current litigation.  Id. at *513.  In other words, plaintiffs can kick the tires, but they aren’t getting under the hood.   

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