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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. 

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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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We’ve written before about the long-running Muldoon v. DePuy Orthopedics lawsuit.  For one thing, it’s been around forever – its facts are almost as old as the Blog.  As we stated here:

Muldoon . . . is a suit over hip-replacement surgery conducted in 2007.  Suit was not filed, however, until 2015 – undoubtedly Muldoon is another example of the flotsam and jetsam dredged up by MDL lawyer solicitation.  So Muldoon was stale from the beginning.  But it got worse. For some eight years, Muldoon sat in the horribly mismanaged Pinnacle Hip MDL in Texas.  It appears that nothing at all happened during those years . . . [until] 2023, when the case was ultimately remanded, without comment.  So, due to the combined lassitude of the plaintiffs and MDL management, the suit is nearly 14½ years post-surgery, and only now being addressed on the pleadings.

(citations and quotation marks omitted).

Finally, in Muldoon v. DePuy Orthopaedics, Inc., 2025 U.S. Dist. Lexis 34013 (N.D. Cal. Feb. 25, 2025), it was dismissed with prejudice.  And in the end, the plaintiff didn’t even put up a fight.  Faced with the defendant’s latest dismissal motion, “[p]laintiff has declined to file any opposition.”  Id. at *2.  What was at stake this time were the claims that had survived the defendant’s first dismissal motion against the plaintiff’s absurdly excessive 18-count post-MDL amended complaint.  We had some words to say about that complaint as well:  “It is a dog’s breakfast.  Or it is what our dogs deliver to our yard right after consuming their breakfast.”

Continue Reading Muldoon Dismissed – The End of an Error?
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Today’s case has shocking facts but not a shocking result. It should come as no surprise that a complaint attacking the safety of an FDA-approved Class III medical device is squarely preempted by the express preemption provision of the Medical Device Amendments, 21 U.S.C. § 360k(a). But somehow, 17 years post-Riegel, that still does not seem to deter plaintiffs from filing plainly preempted claims.

Continue Reading No Shock Here: D. Mass. Holds Complaint Regarding Class III Medical Device Preempted
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In Hall v. Walgreens Boot Alliance, Inc., the Supreme Court of Washington considered a certified question from the Northern District of Illinois on an issue of Washington state law.  No. 102829-6, 2025 Wash. LEXIS 145 (Wash. Mar. 20, 2025).  The underlying case, a proposed consumer protection class action, involves the labeling of a certain over-the-counter cough syrups.  We have seen several cases like this, most often when they have been decided on preemption.  For quite some time, in posts on a wide range of cases, we have pushed two related propositions:  1) a proper preemption analysis should usually start with determining if the asserted state law claim is cognizable as stated before dealing with preemption; to do otherwise invites reverse engineering a non-preempted claim beyond the scope of state law; and 2) when a federal court is sitting in diversity, the Erie doctrine requires that the court not substitute its judgment on what it thinks the state law show be.  Taken together, these propositions favor the use of certified questions to first determine whether state law would provide the relief plaintiffs seek if not for the possibility of preemption.  So, we think it made sense for the Northern District of Illinois to ask the Supreme Court of Washington to determine how the safe harbor in the Washington consumer protection act applied to plaintiffs’ OTC drug labeling claims before deciding if those claims are preempted.  We wish it did not take three years to get this far, but, like arithmetic and assembling items shipped in pieces, the order of operations matters.  Because the actual decision from the Supreme Court of Washington is so obviously wrong, we will have to take solace in the order of operations.  That and how this claim is even more obviously preempted, which seems like the logical next step.

The term “safe harbor” has been applied to a number of things in the legal and real world.  For a long time, fights over off-label promotion turned on compliance with FDA’s safe harbors about when and how requested off-label use information could be shared.  State consumer protection acts, which can be worded so broadly as to make all sorts of benign conduct actionable, also often include their own safe harbors on when conduct that has been blessed by a governmental entity in some form or fashion is deemed, well, safe.  When the artist formerly known as Bexis put together a list of these provisions eleven years ago, we/he had this to say about the Washington law that would become the focus in Hall:

Some state’s statutes exempt conduct in “compliance” with relevant governmental oversight, which we’re taking to mean “FDA,” regulations (Alabama, Colorado, Delaware, Georgia, Hawaii, Illinois, Maine, Minnesota, Nebraska, Nevada, Ohio, Oregon).   Other states exempt anything “permitted” by the relevant regulatory body (Arkansas, Connecticut, Indiana, Maine, Massachusetts, Montana, Nebraska, New Mexico, Ohio, Rhode Island, South Carolina, South Dakota, Utah, Wyoming).   Some states qualify their safe harbors with modifying adverbs, such as “specifically,” “expressly,” or “affirmatively” (Florida, Georgia, Idaho, Illinois, Indiana, Michigan, New Mexico, Ohio, Tennessee, Utah).  A broader formulation exempts anything that is government “regulated” (Alaska, Nebraska, Oklahoma).  A narrower formulation exempts only conduct “required” by the regulator (Florida, Idaho, Indiana, Ohio, Utah, Wyoming). Another variant is “authorized (with or without adjectives) (Illinois, Michigan, Tennessee, Virginia), or alternatively “authorized or approved” (Kentucky).  Then there are New York (“subject to and complies with”), Washington (“permitted, prohibited or regulated”) and California (a common-law carve out for “business practices which the Legislature has expressly declared to be lawful in other legislation,” see Cel-Tech Communications, Inc. v. Los Angeles Cellular Telephone Co., 973 P.2d 527, 542 (Cal. 1999)), which don’t follow anybody else’s pattern.

With all due respect to the grouping in the prior post, the safe harbor in the Washington consumer protection act, although really poorly written, appears to differentiate based on which governmental entity is providing oversight for the challenged activity.  It starts off by saying that the chapter does not apply to “actions or transactions otherwise permitted, prohibited or regulated under laws administered by the insurance commissioner of this state, the Washington utilities and transportation commission, [strangely missing conjunction] the federal power commission.”  Revised Code of Washington 19.86.170 (emphasis added; conjunction not supplied).  It continues, without punctuation or numbering, with “or actions or transactions permitted by any other regulatory body or officer acting under statutory authority of this state or the United States.”  Id. (emphasis added;strange ending colon converted to a period).  Then follow a number of exceptions and exceptions to exceptions that appear inapplicable to the apparent catchall for a federal regulator unless the “actions and transactions [are] in connection with the disposition of human remains.”  The certified question in Hall was whether, under this murky safe harbor, “labeling as ‘non-drowsy’ an over-the-counter antitussive containing dextromethorphan hydrobromide an ‘action[ ] … permitted by … [a] regulatory body … acting under statutory authority … of … the United States’ such that this labeling decision falls within the statutory safe harbor?”  We are not sure this is the right question, but it is not really the question the Supreme Court of Washington answered.

The question of Washington law really was what is required for a safe harbor based on a non-enumerated federal agency such as FDA.  The question of application and implication to the underlying proposed class, which was reserved by the Northern District of Illinois, was whether FDA’s actions with regard the labeling of the OTC cough syrups met the proper safe harbor standard.  A brief detour to Hall’s allegations about the products and FDA’s role is required.  We say brief in part because the opinion clearly presented any incomplete, plaintiff-friendly view of FDA’s role; the concurrence has a somewhat more thorough examination of monographs, as well as the history of the consumer protection act and its safe harbor provision.  A deep dive into monographs and OTC drug regulation in general is beyond our scope here, but we can say that the regulatory scheme applicable to plaintiffs’ theory is more involved than whether the applicable monograph directly says products with the particular active ingredient at issue in the case can be labeled “nondrowsy.”  2025 Wash. LEXIS 145, *3.  The putative class rep bought “one of these over-the-counter cough medicines”—presumably one labeled as “nondrowsy” although the class allegations cover multiple products with and without the designation—allegedly became “unexpectedly drowsy,” and sued because “drowsiness is a known side effect of medicines containing dextromethorphan hydrobromide.”  Id. at *2.  This case, of course, has all the hallmarks of a lawyer-driven litigation with no real aim but to force a settlement over a non-issue that produced no injuries.  The angle the lawyers like is that the FDA monograph requires OTC cough syrups with diphenhydramine to come with a drowsiness warning, but does not say if the ones without diphenhydramine can identify themselves as nondrowsy.

For the Supreme Court of Washington in Hall, the safe harbor was interpreted narrowly to help to “accomplish [the statute’s] beneficial purposes of protecting the consumer.”  Id. at *5.  That led it to read the statutory provision “actions or transactions permitted” as requiring that “an agency must take ‘overt affirmative actions specifically to permit the actions or transactions engaged in’ by the person or entity involved in a Consumer Protection Act complaint.”  Id. at *7 (emphasis added and internal citation omitted).  Noting that the statute states that specified regulatory entities are covered by the safe harbor based on actions they “permitted, prohibited or regulated,” the difference in phrasing for other regulatory entities means “that the legislature intended the statutory safe harbor for activities regulated by nonenumerated agencies to be limited to actions or transactions expressly permitted by the agency.”  Id. at *8-9.  One problem with this analysis is that states that wanted to make a safe harbor be tied to actions “specifically,” “expressly,” or “affirmatively” permitted by a regulatory agency, such as Florida, Georgia, Idaho, Illinois, Indiana, Michigan, New Mexico, Ohio, Tennessee, and Utah per our old post, actually used those adjectives in the drafting of their own safe harbor provisions.  Interpreting “permitted” to mean the exact same thing as “specifically permitted,” “expressly permitted,” and “affirmatively permitted” does not make much sense, especially when it comes to a regulatory scheme as complicated as applies to monograph OTC drugs.

Hall went a step further and concluded that “[a]s FDA has not specifically permitted labeling these over-the-counter drugs nondrowsy, that activity falls outside the statutory safe harbor.”  Id. at *10.  We can quibble with that conclusion, but it also clear that removing the word “specifically” from standard—that is, making the standard match the statute—should lead to the opposite conclusion.  This is certainly not the first time that a court has contracted its safe harbor to allow a dubious consumer protection case about a drug to proceed.  Here, however, the issue of whether the state law claim is preempted by the FDCA is still alive.  Consumer protection claims are not saved from express preemption under 21 U.S.C. §379r, and the plaintiffs’ claim is Hall is clearly based on a state requirement that is “different from or in addition to, or that is otherwise not identical with” federal requirements.  We would say that means express preemption is a slam dunk, but even dunks get blocked sometimes.

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You can find useful legal precedents in surprising places.  For example, Schmidt v. Schmidt, 2025 Pa. LEXIS 389 (Pa. March 20, 2025), is an interesting off-label use decision coming in a context that that most litigants of such cases will miss: a workers’ compensation case.  But if you have been following this blog, Schmidt will not be much of a surprise, because we covered the earlier ruling in that case here.  In that earlier ruling, a majority of the Pennsylvania Commonwealth Court held that where a doctor prescribed a cannabis oil (CBD) to a workers’ compensation claimant for treatment of pain from a workplace injury, the purchase of the CBD is reimbursable by the workers’ compensation system.  The workers’ comp board had denied coverage, leaning heavily on the refusal of the Food and Drug Administration (FDA) to approve medical use of CBD.  The Commonwealth Court overturned the workers’ comp board.  The majority opinion reasoned that the FDA’s non approval of CBD (indeed, the FDA had even pursued off-label prosecutions against some CBD sellers), did not affect the legality or reimbursability of the CBD in this case.

Now the Pennsylvania Supreme Court has unanimously affirmed the Commonwealth Court and held that an off-label use of the CBD (a use that the FDA “has concluded that it has not been proven safe or effective”) does not make prescription of the product illegal.  That’s right, the employer in Schmidt made essentially the same off-label = illegal argument that we DDL bloggers have been opposing since the Bone Screw litigation of the 1990s. That argument failed then, in the context of product liability/medical malpractice. See Southard v. Temple Univ. Hosp., 781 A.2d 101, 104 (Pa. 2001). In Schmidt, the same argument failed in the context of workers’ compensation. Schmidt held that a compensable treatment need not be approved by the FDA or even regulated by the FDA at all.  “FDA approval of a treatment is not a requirement under the [statute], and despite that the FDA has not approved some firms’ marketing of CBD oil as a dietary supplement, its use is not otherwise illegal.”  CBD oil is lawfully sold over the counter in Pennsylvania. The Pennsylvania Supreme Court saw its task in this case as statutory interpretation, and read the statute to mean that “any item that is part of a health care provider’s treatment plan for a work-related injury falls within the purview of the broad-encompassing phrase ‘medicines and supplies’ in the statute.”  The Supreme Court also held that the claimant was not a “provider,” and therefore did not need to submit specific paperwork containing detailed billings and service codes.  It was a complete win for the claimant.

And now we cannot resist saying a few words about the claimant’s story.  You might have noticed that this is one of those cases with the same name on both sides of the v.  One inevitably thinks of Jaurndyce v. Jaurndyce, the lawsuit in Bleak House that droned on for decades and visited ruin on all parties.  In Schmidt, the plaintiff was a lawyer at a law firm bearing that same name.  Is the plaintiff a name partner in the law firm?  A relative?  Merely someone with the same name?  (We work at a law firm with very common names above the door and at the top of the stationery.  Surely, some luckily surnamed young lawyers have joked to their friends and family that they immediately stepped in as name partners at an AmLaw 100 firm.) In any event, the Schmidt plaintiff was in the workers’ comp system because of a work-related – here, legal work-related – injury.  Specifically, the claimant “was squatting to load files into a trial bag, tipped the trial bag onto its wheels, experienced ‘a sudden sharp increase in low back and right leg pain,’ and fell over onto his side.”  One sympathizes.  A workers’ compensation judge described the work-related injury as “an aggravation of his preexisting degenerative disc disease at L4-5 and L5-S1 with radiculopathy.”  It was a serious injury and the pain “progressively worsened.” The claimant desired “to exhaust all non-surgical options before undergoing surgery due to the inherent risks associated therewith and the likelihood of a prolonged recovery time.”  He took opioids multiple times per day.  Nevertheless, the “extensive driving and sitting in courtroom chairs associated with Claimant’s employment continued to aggravate his pain.”  Again, one sympathizes.  At this point, the claimant’s doctor prescribed the CBD oil.  The hope was that it would alleviate the pain and avoid the need to up the opioid doses.  The good news was that the CBD oil seemed to work.  The bad news was that the employer did not wish to pay for it.  And then the claimant got the adverse ruling from the workers’; comp board, followed by the favorable rulings from the Commonwealth and Supreme Courts.  And we DDL hacks got a favorable ruling we might be able to use when plaintiffs seek to demonize alleged off-label use.

But the Schmidt decision also got us to thinking about legal work-related injuries.  We are now at an advanced age when we can tweak our back without any hint of trauma.  Merely sitting down or reaching for our phone can invite back spasms. One time in our office we were beset by such excruciating back pain that we felt utterly immobilized. We pondered the prospect of planting ourselves at our desk for hours or days, reading advance sheets until some sweet release ended the pain. But it is not as if we can pinpoint any pain to a certain event, such as the Schmidt claimant’s battle with a recalcitrant trial bag.  Thinking back, we can dimly recall moments in court when we might have torn a meniscus by leaping to a conclusion, or sprained a ligament by stretching an argument.  Moreover, the occasional judicial slap-down has, at a minimum, hurt our feelings.  But we doubt that even the magnanimous Pennsylvania Supreme Court would deem any of that compensable by workers’ comp or any system.  If any of you know of weird legal work-related injuries, send them in to us.  As Nora Ephron said, “everything is copy.”  If we get enough legal injury tales of woe, we can turn them into a blogpost.  It might not be a particularly instructive blogpost, but we could all benefit by stretching our powers of sympathy.  Or maybe it would just add up to schadenfreude, which also has therapeutic value.  

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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