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We’ve discussed our Drug and Device Law Blog elder care duties before and how it has educated us about health issues faced by the senior population.  Shingles is one health risk that increases as you get older.  It is often described as a painful rash, but “painful rash” doesn’t really capture how bad shingles can be.  “Intense burning sensation” with pain that “can last for months or even years after the rash goes away” is closer, but still falls short of the acute reality of the experience.

Shingles is caused by the varicella-zoster virus, the same virus that causes chickenpox. If you’ve had chickenpox, you have the varicella-zoster virus in your body and, if it reactivates as you age, it will manifest as shingles.  Fortunately, vaccines can provide protection. 

But where there are vaccines, there will be litigation, and we’ve written before about litigation involving one of the shingles vaccines, Zostavax.  From a defense perspective, the In re Zostavax MDL has had its ups and downs, but mostly ups. 

On the downside, the MDL judge recently gave 43 plaintiffs a pass for failing to serve their complaints within 90 days as Federal Rule of Civil Procedure 4(m) requires.  See In re Zostavax (Zoster Vaccine Live) Prods. Liab. Litig., 2023 U.S. Dist. LEXIS 138412, 2023 WL 5044944 (E.D. Pa. Aug 8, 2023).

But on the upside, the MDL judge has not always indulged plaintiffs who fail to follow through on their procedural obligations.  He dismissed—with prejudice—the claims of a plaintiff who failed to timely serve discovery (the ever-problematic “plaintiff fact sheets” found only in MDLs).  See In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2022 U.S. Dist. LEXIS 143883, 2022 WL 3309471 (E.D. Pa. Aug. 11, 2022).

In fact, Zostavax has made our year-end “best of” lists twice, in 2022 (#10) and 2021 (honorable mention).  The Court entered a Lone Pine order with teeth in In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2022 U.S. Dist. LEXIS 57935, 2022 WL 952179 (E.D. Pa. March 30, 2022), and In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2022 U.S. Dist. LEXIS 219261, 2022 WL 17477553 (E.D. Pa. Dec. 6, 2022), requiring all plaintiffs alleging one type of injury (vaccine-induced shingles) to disclose the results of a genetic test distinguishing between wild varicella virus and the weakened, vaccine strain, and dismissing the claims of plaintiffs who lacked proof their shingles was from the vaccine strain. The MDL Court also entered summary judgment in 2021 against five bellwether plaintiffs after excluding all their experts on Rule 702 grounds.  See In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 579 F. Supp. 3d 675 (E.D. Pa. 2021).

Earlier this year, the MDL Court also dismissed some claims on “warning causation” grounds.  Certain California plaintiffs claimed there was a failure to warn about the risk of peripheral neuropathy, but the prescribing physician “never said that knowledge of such a risk would have changed her decision to prescribe it” and plaintiffs’ experts said they only cared about “common” side effects and offered no opinion about “the incidence of peripheral neuropathy as a side effect of Zostavax.”  In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2023 U.S. Dist. LEXIS 45440, 2023 WL 2562981 (E.D. Pa. March 16, 2023).  In other words, these plaintiffs hadn’t shown that the alleged failure to provide the peripheral neuropathy warning would have mattered.

And that brings us to the latest Zostavax order, In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2023 WL 6465837 (E.D. Pa. Oct. 4, 2023), and it’s another good one.  It involved a bellwether plaintiff who’s alleged Zostavax injury was “persistent daily headache” (or “PDH”), which she described as mild headaches lasting “fifteen to thirty seconds.”  Id. at *2.  

To support her case, this plaintiff offered the testimony of Dr. Joseph Jeret, apparently a frequent-flyer expert witness available to cover any number of medical specialties and alleged injuries.  Dr. Jeret opined that Zostavax can cause PDH (general causation) and in fact did cause PDH in this plaintiff (specific causation). 

But Dr. Jeret never met or examined the plaintiff, and developed his opinion based on a review of a select 44 pages of her medical records and two depositions.  Suffice to say the opinion already had a shaky foundation.

Next, Dr. Jeret’s general causation opinion (that Zostavax can cause PDH) was based on, in Daubert and General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997), terms, ipse dixit.  His chain of not-really-connected links was as follows:

First, it is undisputed that Zostavax is a live-attenuated virus vaccine, which can cause infections and headaches. The Zostavax warning label confirms that headaches can result. Second, the most commonly known trigger of PDH is “infection and flu-like illness.” Id. Dr. Jeret notes that 22% of the cases of PDH are a result of infection. Third, the odds of contracting PDH from an infection increases in individuals with immunosenescence, that is, individuals whose immune systems have weakened with age, and in individuals with prior trauma. Fourth, Dr. Jeret concludes Zostavax can cause PDH in older people.

Id. at *3.

As the Zostavax judge quickly surmised, Dr. Jeret’s general causation conclusion was not reliable because:

It does not follow that simply because Zostavax can cause an infection and headaches in older people or people that have experienced head trauma, that it can cause PDH.

Id. at *4.  No epidemiology supported the conclusion that Zostavax causes PDH.  The Zostavax label reporting headaches as a common adverse event does not mean that Zostavax causes PDH, a distinct medical condition.  Notably, Dr. Jeret’s opinion that “any infection from Zostavax could result in PDH is merely a theory based on biological plausibility” and “is no more reliable than an opinion that moonlight can cause skin cancer merely because there is a study that sunlight can cause skin cancer.”  Id. 

Dr. Jeret’s specific causation opinion also fell short of the admissibility mark.  His PDH diagnosis did not fit the accepted diagnostic criteria, and he failed to account for the plaintiff’s pre-vaccination history of migraine headache in reaching his PDH diagnosis.  He basically decided Zostavax caused PDH in the plaintiff based on temporal proximity, and never performed a differential diagnosis. 

Because Dr. Jeret did not employ reliable methods in reaching his general or specific causation opinions, his testimony was excluded.  Assuming this plaintiff has no other expert testimony on medical causation, we can only assume that summary judgment will be forthcoming.

UPDATE:
A few days after this post, the Zostavax court issued another Rule 702 opinion, In re Zostavax (Zoster Vaccine Live) Prods. Liab. Litig., 2023 U.S. Dist. LEXIS 183958, 2023 WL 6626581 (E.D. Pa. Oct. 11, 2023). This latest opinion relates to a claim that his Zostavax inoculation caused one plaintiff to develop Guillian-Barré syndrome. The experts in this case theorized that administration of a live-attenuated virus process can trigger an autoimmune response through a process called “molecular mimicry”. This time, the Zostavax court concluded that the general causation opinions were sufficiently substantiated (including through epidemiological evidence) to meet Rule 702’s admissibility standard. As to specific causation, however, the expert testimony still fell short. The specific causation opinion was based on a differential diagnosis, but one that did not consider whether the plaintiff’s Guillian-Barré syndrome was idiopathic–even though 1/3 to 1/2 of Guillian-Barré syndrome cases have an idiopathic cause. Failure to consider an obvious alternative cause, without good grounds for doing so, renders an expert’s differential diagnosis opinion unreliable, requiring its exclusion under Rule 702 (and Daubert).

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Long before the Supreme Court decided Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022), Bexis was concerned that FDCA preemption would be dragged into the country’s culture wars by the abortion issue.  He hoped the Supreme Court would adhere to long-established precedent and thus keep FDCA preemption out of politics and in product liability litigation where it belonged.  Dobbs extinguished that hope (and many others), so Bexis decided that he might as well embrace the inevitable.

He proposed writing his own law review article on this subject – about which he knows as much as anyone – to the Food & Drug Law Institute.  FDLI accepted the proposal, and now, over a year later, the article is now published:  Beck, Danziger, Johansen & Hayes, “Federal Preemption & the Post-Dobbs Reproductive Freedom Frontier,” 78(2) Food & Drug L.J. 109 (2023).  The article is available to the public at the journal’s website, here.  Bexis hardly did this alone, being ably assisted by three (then) Reed Smith colleagues, Philip W. Danziger, Sarah B. Johansen, and Andrew R. Hayes.

Continue Reading Bexis Publishes Article Applying FDCA Preemption to Medication Abortions
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[This post is not from the Reed Smith side of the blog.]

Litigation is a game. It is a game with real stakes and broad implications, but it is nonetheless a game played according to certain rules. As in all games, the participants—plaintiffs and defendants alike—try to maximize their advantage within those rules.

In litigation, the rules governing jurisdiction—i.e., the rules that determine which court has the authority to resolve a dispute—are the most important foundational rules. Sometimes those rules, such as the rules controlling personal jurisdiction, allocate cases between courts in different states. Other times, those rules, such as the rules controlling subject-matter jurisdiction, allocate cases between federal and state courts within a single state.

Rules allocating cases between federal and state courts have a significant impact on the course of litigation. Federal rules of procedure and evidence are different, sometimes in material ways. But more than that, federal courts are different from state courts.

Although state-court judges have substantially larger dockets than their federal counterparts, they typically have fewer clerks to assist them (and the clerks that they do have are on average less academically accomplished than federal clerks). As a result, state-court judges often lack the resources that federal judges can devote to individual cases. In our experience, this means that motions to dismiss and motions for summary judgment are more likely to be denied in state court than in federal court because state-court judges, desperate to manage their overloaded dockets, would rather not spend time addressing difficult legal and factual questions when the cases presenting those questions might simply disappear, whether through settlement or otherwise.

Of course, there is yet another significant difference between state and federal courts. Federal judges are appointed for life while many state judges are elected. Dependent on campaign donations and electoral favor, state-court judges are far more susceptible to political influence than federal judges. Given a generous plaintiffs’ bar and the rule of numbers, in many jurisdictions this translates into a pro-plaintiff tendency.

Given those realities, corporate defendants generally do better in federal court than state court. It is for this very reason that plaintiffs, seeking to maximize their litigation advantage, tend to file cases in state rather than federal court. Conversely, it is why defendants often try removing those cases to federal court under 28 U.S.C. § 1441, which allows a defendant sued in state court to have the case adjudicated in federal court so long as the case could originally have been brought in federal court.

That brings us to today’s case, Wood v. Dexcom, Inc., 2023 WL 6064690 (S.D. Cal. 2023). Asserting product-liability claims against the defendant device-manufacturer, the plaintiff initiated suit in California state court. Invoking § 1441, the defendant removed the case to federal court even before the complaint was served, contending that the court had original jurisdiction over the matter under U.S. Const. art. III, § 2, cl. 1 because the parties were citizens of different states. The plaintiff moved to remand the case to state court, arguing that the “forum defendant” rule codified at 28 U.S.C. § 1441(b)(2) barred removal even though there was complete diversity of citizenship between the parties. The court agreed with the plaintiff and remanded the case to state court.

At the heart of the dispute is the validity of so-called “snap” removals—notices of removal that are filed before service on all defendants has been completed.

Under § 1441(b)(2), a case that could otherwise be removed to federal court based on the basis of diversity jurisdiction “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” Known as the “forum defendant” rule, this generally prevents removal when any defendant is a citizen of the state in which the suit was brought.

“Generally” is the operative word because, as in Wood, defendants will sometimes try to remove cases even if one defendant is a citizen of the forum state. Relying on the “properly joined and served” provision, defendants maintain that removal is proper despite the forum defendant so  long as the forum defendant has yet to be properly served.

As we’ve discussed before here and here (but the Wood court failed to acknowledge), courts are divided on the question of snap removals. Courts such as the Third Circuit apply the statute’s “plain meaning,” holding that § 1441(b)(2) unambiguously allows removal so long as no already-served defendant is a citizen of the forum state. Encompass Ins. Co. v. Stone Mansion Rest. Inc., 902 F.3d 147, 152 (3d Cir. 2018). Other courts disregard the statutory text, finding removal-before-service a non-sensical result that fosters gamesmanship.

According to the courts who reject snap removals, the forum-defendant rule embodied in § 1441(b)(2) recognizes that the purpose of diversity jurisdiction—avoiding bias against out-of-state defendants in state courts—has no role to play when a defendant is a citizen of the forum state.

Question whether the presence of a lone in-state defendant is sufficient safeguard against local favoritism. But even if it is, that does not change the fact that state courts are, for the reasons explained above, often tilted against corporate defendants sued by individuals, whether or not those corporations are citizens of the forum state. Nor does it change the fact that plaintiffs bring actions in state court for that very reason. Thus, it blinkers reality to suggest that there is no reason to anticipate disparate treatment when a corporate defendant is forced to defend itself in state court.

Whatever the empirical reality, § 1441(b)(2) says what it says. Once a forum defendant has been properly served, removal cannot be based on diversity of citizenship. But that prohibition applies only after a forum defendant has been properly served. Because they can decide in which forum to file suit, plaintiffs have a built-in procedural advantage that allows them to steer cases to state courts where—because of limited judicial resources and electoral politics—plaintiffs enjoy certain substantive advantages. Courts should not enhance plaintiffs’ advantage by ignoring § 1441(b)(2)’s “unambiguous” text. Encompass Ins., 902 F.3d at 152.

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We acquired our trial chops in the Central District of California, where we were an AUSA.  We had a great time. We learned a lot. We have warm feelings for C.D. Cal.  But we do not love all the decisions that come out of that jurisdiction. 

Burton v. Abbvie, Inc., 2023 U.S. Dist. LEXIS 170907 (C.D. Cal. Sept. 25, 2023), is a not very good decision.  It applies California law to prop up a claim that a prescription drug caused the plaintiff to suffer from Stevens Johnson Syndrome/Toxic Epidermal Necrosis (SJS/TEN). SJS/TEN cases are problematic because they usually involve serious, disfiguring injuries to sympathetic plaintiffs. The Burton case is complicated by a regulatory quirk: before the plaintiff’s use of the drug (eye drops for treating conjunctivitis) the manufacturer submitted a label change that specifically warned of SJS, but not TEN. Does that matter?  Does that make medical sense?  Does that undermine the plaintiff’s claims for failure to warn, negligent misrepresentation, gross negligence, fraud and fraud by concealment?

The plaintiff used a generic version of the eye drops, but sued the brand manufacturer under the theory of innovator liability.  That theory is unsound and unfair, but the case is in California, which gave us the doctrinal abomination of T.H. v. Novartis. Thus, the Burton court pauses only very briefly on the innovator liability issue before getting to – and bungling – the other defense arguments. 

Let’s frame the first defense arguments as a couple of very basic questions: Where’s the failure to warn? What’s the fraud?

The plaintiff claimed that TEN was “different” from SJS, so the amended warning was still defective.  Not citing any case where such a distinction had been recognized, the Burton court held the difference between SJS and TEN, and the significance of such difference, to be questions of fact “that will require medical expert testimony to resolve.”  There are plenty of cases out there discussing the relationship between SJS and TEN (it is a difference in degree), but the Burton court felt bound by the allegations of the complaint, and held that there just might be a valid claim that an SJS warning might be inadequate. Grrrr. To paraphrase our favorite police officer character (Bunk) from our favorite TV show (The Wire) criticizing our favorite villain (Omar), it makes us sick to see how far we’ve fallen. 

Speaking of peak TV, this is the part of the show where preemption rides in to the rescue, right? Wrong. The defendant argued that the plaintiff’s claim was preempted because she did not sufficiently allege the existence of newly acquired information that would have allowed the defendant to change the drug label without FDA approval.  Again, the Burton court stood on procedural ceremony so as to dodge the crucial issue. Here is how the dodge works: (1) Preemption is an affirmative defense, therefore (2) unless a plaintiff does the defense the immense favor of pleading what amounts to Albrecht “clear evidence” that the FDA would have rejected a label change, then (3) a motion to dismiss based on preemption must be denied. 

As if to recognize the sophistry of this syllogism, the Burton court also held that the plaintiff sufficiently pleaded newly acquired information to avoid preemption.  Since TEN is different than SJS (see above), any literature regarding TEN is newly acquired, regardless of the intervening label change addressing SJS.  More sophistry.  And then it gets worse.  Even if the proposed warning information set forth in the complaint is old stuff, that is “irrelevant” because newly acquired information includes data, analyses, or other information that, according to the Burton court, was not previously submitted to the FDA. Because the defendant did not establish that any information available at the time of the label change was necessarily submitted to the FDA, the preemption argument suffers defenestration. (For those of you unfamiliar with that curiously Central European method of dealing with political or religious opponents, defenestration means thrown out of an upper story window). 

We think the Burton court misunderstands what “newly” means, and the only way it can make that misunderstanding work is to violate Buckman preemption.  The case ends up becoming focused on whether the defendant hid information from the FDA. That seems utterly wrong. The Burton court protests (too much) that the plaintiff is not alleging a preempted fraud on the FDA claim, but only a failure to submit information to the FDA pertaining to the defendant’s preemption defense.  That sounds like classic Buckman to us.  

Throw a dart at the Burton opinion and you’ll find something bad. The Burton court smiles upon the plaintiff’s nitpicking of the SJS warning in various ways. For example, the plaintiff insisted that racial and sexual differences in SJS/TEN incidence should have been included.  (The plaintiff was African-American). That is a fairly common claim in SJS cases. That sort of thing is hardly free from controversy, and it would probably make more sense for the FDA, rather than a jury, to decide whether to touch that hot stove.  

In any event, that label nitpicking permitted the plaintiff to escape Rule 9(b) dismissal for want of specificity. Silly specificity is still specificity, and that’s what counts, apparently.  

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We say today’s case is about SIRVA (shoulder injury related to vaccine administration), but plaintiff tried her best to run from that allegation in her opposition to defendants’ motion to dismiss.  That’s because a SIRVA case runs up against not only a preemption obstacle, but also serious duty and causation barriers.  But since the court was not accepting on the fly pleadings amendments, plaintiff’s first amended complaint was dismissed, and she was offered one final opportunity to try to plead a case that could survive preemption and causation.  As we read the opinion, we don’t think that is likely.

The case is Garcia v. Sanofi Pasteur Inc., 2023 U.S. Dist. LEXIS 175717 (E.D. Cal. Sep. 29, 2023).  Plaintiff received injections in her right shoulder for both the pneumonia vaccine and the TDaP vaccine.  Two days later she returned to the clinic complaining of right shoulder pain. The pain continued and eventually, plaintiff was diagnosed with a partial tear of her rotator cuff and “frozen shoulder,” which required surgery.  Id. at *2-3.  In her complaint, plaintiff alleged that the package inserts, patient information sheets, and vaccine information sheets for each vaccine did not include warnings for chronic pain, torn rotator cuff, and frozen shoulder.  Id. at *6.  But that defendants knew or should have known of these side effects because her injuries are typical for someone suffering from SIRVA and that SIRVA claims had been filed “for years” before plaintiff received her vaccinations.  Id.   

Plaintiff’s first failure to warn claim was that defendants failed to warn her directly or the general public of these risks.  That claim is expressly preempted by the Vaccine Act.  Id. at *11 (no liability due to “manufacturer’s failure to provide direct warnings to the injured party.”  42 U.S.C. § 300-aa-22(c)).  Plaintiff tried to argue that her claims fell within a preemption exception because defendant failed to exercise due care.  The court was not sure the exception applied at all to the type of claim plaintiff was asserting but did not have to decide that issue because the complaint did “not contain any non-conclusory factual allegations suggesting the absence of due care.”  Id. at *13.  The complaint merely reiterates that defendants failed to warn and/or that the warnings were defective.  Plaintiff did not plead any facts to establish a due care exception. 

Plaintiff’s failure to warn her directly or the general public also failed under the learned intermediary doctrine.  Under California law, the only failure to warn claim is a failure to warn plaintiff’s medical provider/vaccine administrator.  Id. at *15. 

And, as to that claim, plaintiff failed to plead either a duty to warn or causation.  California does not require a manufacturer to warn of a known or obvious risk.  Id.  Because plaintiff pleaded that SIRVA was a well-known risk in the medical community, it stands to reason that defendants did not have to warn about it.  So, in opposition to the motion to dismiss, plaintiff argued she was not really suffering from SIRVA and tried to introduce facts not alleged in her complaint.  The court was only willing to look at plaintiff’s claims as “currently couched” – “that she suffered a well-known ailment associated with the improper administration of a vaccine.”  Id. at *16.  Therefore, plaintiff failed to allege that defendants had a duty to warn her medical provider.

Plaintiff also failed to plead causation—that a different warning would have changed her doctor’s prescribing decision.  Id.  Plaintiff only alleged that she would not have consented to the vaccines if she had received a different warning.  As noted above, plaintiff has no direct-to-consumer warnings claim, so her decision is irrelevant.  Moreover, plaintiff did not allege that the vaccines themselves, as opposed to their improper administration, caused her injuries.  The complaint alleges plaintiff suffers from SIRVA, which she does not dispute is the result of improper administration.  While plaintiff may actually want to claim she suffered a torn rotator cuff and “frozen shoulder,” the complaint also does not allege how those conditions are caused by the vaccines rather than their administration.  Since the court cannot go beyond the face of the pleadings, plaintiff’s claims were dismissed for failure to adequately plead causation.  Id. at *17.

Plaintiff is going to have to put a lot of distance between herself and SIRVA to plead a case against the vaccine manufacturers that has a chance of surviving preemption or TwIqbal.  She may hope the third time is the charm, but we’re betting on three and out.

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We have often characterized preemption as one of the most powerful tools in product liability defense lawyers’ toolboxes.  It also gets utilized effectively by lawyers defending against a variety of consumer fraud cases about FDA-regulated products.  We have, for instance, covered a number of decisions where plaintiffs complained about a range of food labeling issues that are often quite trivial, like how much air is in a bag of chips or whether a food labeled “organic” meets the plaintiff’s personal standards.  We also have talked about nutritional supplements, which occupy part of the regulatory space between food and drugs.  In 1994, the FDCA was amended by the Dietary Supplement Health and Education Act and carved out requirements for, you guessed it, dietary supplements.  What is a dietary supplement is defined pretty broadly, but it does not include any substance regulated as a drug.

Vitamins are an obvious example of dietary supplements and the case discussed here involved Vitamin E.  Enzymes are also supplements.  If you have insufficient resources of the enzyme lactase to help you digest the dairy you ingest, then you will probably know it, as may those around you.  Well, there is a supplement for that.  Some people with lactose intolerance—that is, people who do not make enough lactase to handle lactose, the sugar found in dairy—consume goodly amounts of the supplement rather than eschew a gooey slice of real cheese pizza.  We can pause to appreciate why complete avoidance of lactose-rich cheese may not be a realistic option for everyone.  And there is an ice cream cone on a hot day, with melt floes that require lingual dexterity, social mores be damned.  If we are done with that bit of dairy decadence, we can turn to DiCroce v. McNeil Nutritionals, LLC, No. 22-1910, — F.4th –, 2023 WL 6056144 (1st Cir. Sept. 18, 2023).  The plaintiff brought a consumer protection suit on behalf of a putative class of Massachusetts purchasers of a well-known enzymatic supplement who were allegedly deceived by its labeling.  Well, it was about the labeling only in a roundabout way.  It was more of a stop selling theory, but not tied to purported risks or lack of efficacy.  We can explain.

Fundamentally, the plaintiff claimed that lactose intolerance is a disease, the enzymatic product treats this disease, and it should really be regulated as a drug instead of a supplement.  Id. at *1.  The labeling claims flow from that.  We suppose a citizen’s petition to FDA would be a way to challenge its regulatory approach, but a consumer protection surely was not.  The district court dismissed the case because the plaintiff had failed to plead the elements of the state law with sufficient facts to state a claim.  Id. at *2.  On appeal, the First Circuit affirmed on a more fundamental issue:  implied preemption of a state law claim predicated entirely on a purported violation of the FDCA.  As we have said many times over the years, only the FDA can enforce violations of the FDCA, which provided no private right of action.  Id. at *3.  As such, “§337(a) [of the FDCA] preempts any state-law claim that exists ‘solely by virtue’ of an FDCA infraction.”  Id. at *4 (citation omitted).  By contrast, conduct that would violate the FDCA and the Massachusetts consumer protection law “if the FDCA did not exist” is not preempted.  Id. (citation omitted).

Plaintiff complained that the supplement’s labeling mislead consumers by “disclaiming [FDA] approval, thereby implying that FDA approval is not required,” which it would have been had the product been regulated as a drug.  Id. at *1.  While simultaneously circular and tenuous, this theory of liability clearly hinges on the hinges on the exist of the FDCA’s regulatory schemes for drugs and supplements.  Without the FDCA, there could be no misleading statement about the lack of FDA approval.  Of course, the supplement label’s statement about the lack of FDA approval was “literally true,” using the redundant language of plaintiff’s complaint.  Id.  Plaintiff “does not contend that [the supplement] did not perform as promised, nor does she provide any basis, independent of federal labeling laws, from which we could conclude that a consumer would be misled by [the supplement’s] label.”  Id.  So, the dismissal was affirmed on the alternate ground that any claim, even if pleaded with sufficient factual support, would be preempted.

Is this decision a victory for the stomachs of lactose intolerant individuals?  Yes.  Will this help deter plaintiff lawyers from bringing lawsuits predicated on the labeling of FDA-regulated products allegedly needing to say things that FDA would not have allowed or on an alternate reality where the FDCA requires different things?  Probably not.  There will still be plenty of lawyers willing to bring such cases, particularly where consumer protection remedies and class action procedures provide the lure of big dollars.

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We don’t write a lot on criminal cases, but published opinions in the Ninth Circuit involving the Food Drug and Cosmetic Act always catch our eye.  In United States v. Marschall, No. 22-30048, 2023 WL 6135771 (9th Cir. Sept. 20, 2023) (to be published in F.4th), the Ninth Circuit held last week that some felony convictions for shipping misbranded drugs do not require proof of scienter, i.e., that the defendant knew that the drugs he or she shipped were misbranded.  Felony convictions are a big deal, and felony convictions without proof of intent or even knowledge are an even bigger deal. 

In our universe of drug and device litigation, you might ask, Why do we care?  We care because the FDCA provision at issue is 21 U.S.C. § 331, which prohibits (among other things) the introduction into interstate commerce any drug that is adulterated or misbranded.  In addition to criminal enforcement, the Act also provides for civil enforcement of Section 331, and the government’s view of “misbranded” drugs can be awfully broad.  The FDA’s prohibition on off-label promotion, for example, is based purportedly on Section 331, on the theory that a drug promoted for one, unapproved purpose is “misbranded” because its label describes another. 

So we read the Marschall case and its treatment of misbranding with some interest.  The defendant was a “naturopathic doctor” (which is new to us, but apparently is a licensed professional who treats patients using mainly natural remedies) who had a prior misdemeanor conviction for selling misbranded drugs.  Id. at *2.  That is a key fact, because when he did it again, the government was able to charge him with a felony under a provision of FDCA reserved for recidivists.  (By the way, although not material to the analysis, the doctor was convicted of selling a “Dynamic Duo” of substances with no active pharmaceutical ingredients, to help prevent, among other things, COVID-19.  Why is it always something about COVID-19?). 

There are two ways to commit a misbranding felony.  One is to violate Section 331 “with the intent to defraud or mislead”—a formulation of scienter that we all recognize from law school.  The second is to violate Section 331 with a prior conviction.  21 U.S.C. § 333(a)(2).  The latter is where the government got the defendant in Marschall.

The upshot is that the recidivist clause of Section 333(a)(2) does not expressly include the element of scienter, and the Ninth Circuit was unwilling to imply one.  Sure, there is a longstanding presumption that criminal laws intend to require that a defendant has a culpable state of mind.  But the government rebutted that presumption here.  First, the statute defines the recidivist version of the misbranding felony by reference to a prior offense that does not itself require scienter, which is allowed for “statutes that regulate potentially harmful or injurious items.”  In other words,

Congress has dispensed with the normal requirement of scienter and has instead “impose[d] a form of strict liability through statutes that do not require the defendant to know the facts that make his conduct illegal.”  [citations.]  Section 333(a)(1), which makes it a misdemeanor to introduce misbranded or adulterated drugs into interstate commerce, is such a public welfare offense, and it does not require the Government to prove “knowledge that the items were misbranded.”

Marschall, at *7.  The recidivist provision ups the ante to a felony, but nothing about the provision adds a scienter requirement to a base offense that lacks a scienter requirement in the first place.  Id.

Second, as a matter of statutory construction, Congress worded differently the two clauses that define the two ways to commit a misbranding felony.  The fact that Congress expressly included scienter (“with the intent to defraud or mislead”) in one clause “strongly confirms” that the other provision—the recidivist provision—does not include a comparable requirement.  Id.  The Ninth Circuit further observed that someone who already has a misbranding conviction has actual knowledge of the statutory prohibition.  That led the court to conclude (somewhat questionably in our humble view) that “a prior criminal conviction under § 333 effectively serves as a functional substitute for a scienter requirement.”  Id. at *8.  The Ninth Circuit disposed of due process concerns with similar reasoning: A person with a prior conviction of the same offense has ample notice of his potential jeopardy.  Id. at *9. 

We have no opinion on whether this naturopathic physician got a raw deal here.  The FDA’s investigation revealed no evidence that anyone was harmed, and the facts suggest that he was up front with at least some purchasers (including the FDA’s undercover agent) that the FDA did not believe in any of his products.  But laws prohibiting the sale of adulterated or misbranded drugs are vital, and the government’s burden in enforcing them appears to be a little different from what you might expect. 

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Our immediate reaction to In re Bard IVC Filters Products Liability Litigation, ___ F.4th ___, 2023 WL 5441793 (9th Cir. Aug. 24, 2023) (hereafter, “Jones” (the plaintiff’s name)), was “popcorn time” – pull up a chair and watch the other side fight like drunken pirates over the MDL spoils.  But there’s more to Jones than that.  The MDL-related “participation agreements” that Jones enforced are something like third-party litigation funding, in that they introduce another party to the settlement mix, even in non-MDL cases.  Defendants thus have a need to know about those agreements when settlement is raised in those cases.

Continue Reading Of MDLs, Settlements, and Common Benefit Contracts
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Thelen v. Somatics, LLC, 2023 U.S. Dist. LEXIS 165819 (Mag. M.D. Fla. Sept. 18, 2023), is the latest chapter in a saga we have covered before. (We discussed decisions on expert admissibility here, invalid claims here, confidentiality of medical records here, and the plaintiff’s highly unusual demand for a plant inspection here.) The plaintiff claimed to have suffered injuries as a result of electroconvulsive therapy (ECT).  The plaintiff sued the manufacturer of the ECT medical device, pursuing causes of action for negligence, strict liability, breach of warranty, and violation of the Nebraska Consumer Protection Act. 

The plaintiff ultimately went to trial on his remaining claims (negligence and strict liability)  and recovered … nothing. The jury found a warning defect, which was nice for the plaintiff, but also found no proximate causation, which was even nicer for the defendant.  Overall, we’d have to say the result was much nicer for the defendant than the plaintiff.  A finding of liability and an award of zero damages is a defense win and a plaintiff loss in anyone’s book, right?

The court clerk entered a judgment in favor of the defendant. Then the court directed the defendant to file a bill of costs.  The defendant did so. Costs exceeded $39,000. Then the plaintiff moved the court to review the costs. The defendant disagreed. Now the costs issue was teed up for the Magistrate Judge. 

So what? While the disposition of individual cost items is case-specific and not especially blogworthy, the court’s rejection of the plaintiff’s two general arguments against taxation of costs is significant.  

First, the plaintiff claimed that, since a defect was found, the defendant was not a “prevailing party” despite its winning an overall defense verdict.  Nice try. (Not really).  The ultimate result, that the plaintiff took nothing, is all that matters.  This was not a mixed outcome case where both parties prevailed on some of their claims.  The judgment here was only for the defendant.  When that happens, the defendant is the prevailing party and is entitled to costs.  “Accordingly, the court finds that Defendant is the prevailing party under Rule 54(d) and is thus entitled to a presumption of taxable costs.”

Second, the plaintiff’s claimed indigency was no basis to deny costs.  The plaintiff argued that “the court should exercise its discretion and decline to award costs because of Plaintiff’s financial status.”  There is, in fact and law, room for judicial discretion in this area. But the Thelen magistrate “decline[d] to recommend considering Plaintiff’s financial status in assessing the taxation of costs.”  Not only did the plaintiff fail to support the claim with anything more than his own self-serving statements, but the “relative wealth” of the parties is not a factor in entitlement to costs.  Limited resources do not overcome the ”strong presumption”  that a prevailing party is entitled to costs.

The Magistrate Judge in Thelen then took a detailed tour through costs of trial transcripts, deposition fees, photocopy fees, scientific article fees, witness fees, and clerk fees. The court ended up sustaining some of the plaintiff’s objections and cut the costs bill down to approximately $27,000. That exercise in flyspecking might be useful for some of you, in which case you should flip through the opinion. We do not find much of general interest in the court’s cost accounting decisions. They are certainly not shocking.

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Is what the court finally had to tell plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2023 U.S. Dist. LEXIS 166742 (C.D. Cal. Sep. 19, 2023) in dismissing his second amended complaint as both preempted and inadequately pleaded.  We posted about the dismissals of the original and first amended complaints on the same grounds here and here.  And really nothing has changed, a consistent theme in this series of decisions.    

The facts have not changed.  Plaintiff was prescribed defendant’s drug to treat his chronic myeloid leukemia.  He alleged that the drug caused him to suffer a loss of vision in his right eye due to hemorrhaging.  Id. at *5-6.  The causes of action have not changed—strict liability failure to warn and negligent failure to warn.  Id. at *1.  The court’s decision to take judicial notice of defendant’s FDA-approved labeling has not changed.   First, courts “regularly take judicial notice of materials prepared by government agencies.”  Id. at *13.  Second, the court was willing to consider the labels under the “incorporation by reference” doctrine because the labels were referenced and quoted in the second amended complaint.  Id. at *13-14.

The court’s preemption analysis has not changed because plaintiff, on his third attempt, still was unable to provide any evidence of any “newly acquired information.”  Prescription drug failure to warn claims are preempted unless plaintiff pleads a labeling deficiency that could have been changed via the Changes Being Effected (“CBE”) regulation.  The CBE regulation permits a manufacturer, without prior FDA approval, to change the label to “reflect newly acquired information” to add or strengthen a warning “for which there is evidence of a causal association.”  Id. at *17.  Newly acquired information is defined as “data, analyses, or other information not previously submitted” to the FDA that demonstrate “risks of a different type or greater severity or frequency than previously included in submissions to the FDA.”  Id.     

Plaintiff’s four “new” allegations purporting to demonstrate newly acquired information that satisfies the CBE regulation are just more of the same old, same old.  Meaning they don’t fit the bill.  First, plaintiff takes issue with how defendant’s clinical trials were conducted but does not allege that any information about how those trials were conducted was withheld from the FDA or that the trials provided any new information.  Id. at *18.  Second, plaintiff tried to argue defendant failed to report adverse event reports to the FDA by relying on adverse event reports that were in the FDA’s FAERS database.  In other words, plaintiff alleged the opposite of newly acquired information, “that the FDA was aware of the adverse event reports but did not take further action.”  Id. at *19-20.  Third, plaintiff pointed to publicly available medical literature but not to what in that literature was unknown to the FDA or different from information already considered by the FDA.  Id. at *19-20.  Fourth, plaintiff alleged that defendant’s patient brochure was inaccurate, which is a challenge to defendant’s marketing materials but has nothing to do with whether defendant had any newly acquired information that would be supported a CBE labeling change.  Id. at *21.  Therefore, for the third time the court concluded plaintiff’s failure to warn claims were preempted. 

The court’s TwIqbal analysis has not changed.   For the third time plaintiff failed to adequately plead causation under the learned intermediary doctrine.  In Roshkovan I, the court told plaintiff that his causation allegations had to include facts sufficient to plausibly support that an adequate warning would have altered his prescribing decision.  In Roshkovan II, the court told plaintiff he still had not done enough on causation because, to plausibly plead causation his complaint had to sufficiently allege how the adequate warning would have altered the prescribing decision.  Yet, in Roshkovan III, plaintiff’s causation allegations remain only that the inadequate warning “proximately caused Plaintiff’s injuries” and if an adequate warning had been given plaintiff’s doctors “would have elected not to use” the drug.  Id. at *23.  Once again, plaintiff is missing the “how.”  Therefore, plaintiff’s causation allegations are “too conclusory” to plausibly plead causation.”  Id. at *24. 

But finally, there is something new to report.  Plaintiff is not getting a fourth attempt.  After dismissing the complaint on the same grounds three times, the court said enough is enough.  Plaintiff’s claims are now dismissed with prejudice.   Id. at *24-25.

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