We have expressed our opinion on “failure to update” claims and have not hidden that we don’t think much of them.  Failure to update claims were manufactured by plaintiffs in response to PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) which basically took the legs out from under products liability suits against generic drug manufacturers.  You know what we mean.  Federal law requires that generic drug manufacturers’ products have the same drug labeling and the same design as their innovator (brand) counterparts—the so-called “duty of sameness.”  Therefore, any claims for failure to warn or design defect are preempted by impossibility.

A “failure to update” claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury.  Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  A few courts, however, disagree and have held such claims are not preempted.  In In re: Fluoroquinolone Prods. Liab. Litig., MDL 2642, 2020 WL 6489186 (D. Minn. Nov. 4, 2020), the court said maybe.

The relevant facts are simple.  On August 15, 2013, the FDA issued a Drug Safety Announcement requiring the warnings for all drugs containing fluoroquinolone be updated to “better describe the serious side effect of peripheral neuropathy.”  See https://www.fda.gov/media/86575/download.  In November 2013, plaintiff ingested generic ciprofloxacin and suffered an adverse reaction.  Plaintiff alleges that the generic manufacturer had not updated its label with the warning set forth in the FDA safety announcement at the time she used the drug.  Id. at *1.

The court started its analysis by finding that the failure to update claim differs from Mensing because unlike the issue before the Supreme Court, here plaintiff is not asking the court to require generic manufacturers to provide additional warnings beyond those required of their brand counterpart.  Because the claim is not about a stronger warning, it does not violate the duty of sameness and therefore does not implicate impossibility preemption.  Id. at *3.  For that reason, plaintiff’s failure to warn claim is limited.  She essentially must concede that the brand warning is adequate and therefore, if provided by the generic manufacturer, would have prevented her injuries.  Id. at *4.

As noted above, implied preemption is another obstacle to the failure to update claim.  Afterall, the requirement to update the warning label is one imposed by the FDCA.  Under Buckman, a private citizen does not have the right to enforce a federal labeling requirement. But the court was willing to entertain a scenario where plaintiff could demonstrate that the failure to update is based on state law as well as a being a violation of the FDCA.  In that case, the claim could thread the preemption needle.  Id.

In sum, the court concluded that if a generic manufacturer failed to update its label to match the brand label, and the claim is limited to the “inadequacies of the non-updated label compared to the updated label,” and there is a state law basis for the claim – it is “not conclusively preempted.”  Id.  In this case, plaintiff did not sufficiently plead any of those elements to survive a motion a dismiss.  Plaintiff did not limit her liability allegations only to the failure to update.  In other words, all failure to warn claims except failure to update must go.  Plaintiff also failed to allege how her failure to update claim is based in state law.  Id.  Because the court was saying “maybe” as opposed to “never,” plaintiff is getting a chance to re-plead her failure to update claim.

Perhaps most importantly, however, the amendment is going to need to address causation.  It is on this ground that other courts in the Eighth Circuit, and elsewhere, have dismissed failure to update claims.  See id. at *6n.3.  Where the learned intermediary has independent knowledge of the risk, the failure to update cannot be the proximate cause of plaintiff’s injury.  As the court noted, “even though failure to update claims are not necessarily preempted, they may be difficult to prove on the merits, particularly in terms of causation between the label and injury.”  Id.   Here the generic and brand labeling already including warnings about peripheral neuropathy.  Based on our own digging, we believe the brand manufacturer added the strengthened warning in July 2013.  The FDA then made its safety announcement for all brand and generic drugs in the class to strengthen their warnings in August 2013.  Regardless of whether it took the generic manufacturer had not updated its label by November, the information was out there.  It was in the medical community.  Further, we know from experience that physicians tend to rely on the brand labeling, not the generic.  Often, the prescribing physician would never have seen the generic label – updated or not.  So, “maybe” may get you over the first preemption hurdle, but causation looms large on the horizon.

It’s Delaware week here at the DDL Blog.  A couple of days ago we brought you a particularly clear-minded order rejecting innovator liability in the First State (so nicknamed because Delaware was the first of the original 13 colonies to ratify the Constitution in 1787), and yesterday we reported on a pair of Delaware orders granting summary judgment in failure-to-warn cases on proximate causation.

Today we highlight another particularly clear-minded application of warning causation in Delaware, and this case has a twist—the product at issue was a generic drug, and the alleged basis for liability was the generic manufacturer’s alleged “failure to update” its label to match the innovator drug.  In the end, however, none of that mattered because the prescribing physician did not read the label and had never heard of the generic company, which means that any “failure to update” could not possibly have made any difference.

The case is Boros v. Pfizer, Inc., No. N15C-04-029, 2019 WL 1558576 (Del. Superior Ct. Mar. 25, 2019), and here is how things played out.  In February 2013, the FDA approved a stronger warning about QT interval prolongation for the innovator version of a common antibiotic.  The agency later requested that the defendant generic manufacturer update its label to match, and it published a Drug Safety Communication about the change.  Id. at *1.  The generic manufacturer complied, and the FDA approved its updated label three months later.  Id. at *2.

In the meantime, the patient at issue was prescribed the antibiotic, and the pharmacy dispensed the Defendant’s generic version.  The next day, the patient died.  Id. at *1.  Because he was prescribed the drug after the innovator changed its label, but before the generic defendant—the manufacturer that actually made and sold the drug the patient allegedly ingested—updated its label to match, the plaintiffs claimed that a “failure to update” caused the decedent’s death.  Id. at *2.

We have expressed our opinion on “failure to update” claims.  We don’t think much of them.  We don’t, however, need to get into all that today because the Delaware court granted summary judgment on warning causation.  The following facts are all you really need to know:

The parties do not dispute that [the prescribing physician] does not recall ever reviewing a package insert for [Defendant’s] generic azithromycin or for any other [Defendant] produced drug.  [He] has never spoken to or had any written communications with any [Defendant] representative.  [He] has never heard of [Defendant].

Id. at *2.  That’s right.  The prescriber did not read the label, never communicated with the Defendant, and never heard of the Defendant.  On those undisputed facts, it was a short way to holding that a “failure to update” the generic label did not cause any harm:

[The prescribing physician’s] failure to review the package insert prevents the Plaintiffs from establishing that the warnings in [the] package insert proximately caused the Decedent’s death.

Id. at *3.  Like other plaintiffs in similar situations, the Plaintiffs tried to get around this stark inability to prove their case.  First, they emphasized the prescriber’s testimony that if he had seen additional warnings, he would have changed his prescribing practices.  This is a version of the “Doctor, wouldn’t you have like to have known” testimony that plaintiffs’ lawyers commonly elicit, usually with an affirmative response.  After all, what doctor will deny that he or she would “liked to have known” additional information about drugs they prescribe?  Be that as it may, the testimony did not prevent summary judgment in this case because the facts were so clear—the doctor never reviewed or received any information from the Defendant.  Under those circumstances there is simply no way that “updated” information would have had any impact on the decision to prescribe the drug.  Id. at *4.

Second, the Plaintiffs argued that the learned intermediary doctrine may be “eroded or even nullified by over promotion of the drug.”  But even if there is an “over-promotion” exception to the learned intermediary doctrine—and Delaware does not have one—it would not apply here because the prescriber never interacted with the Defendant.  Id. at *5.

Third, the plaintiff argued that the learned intermediary doctrine did not apply because the decedent was himself a medical professional and not a “lay person.”  That is a new one on us, and we have never seen any authority that a “learned patient” negates a “learned intermediary.”  Neither had the plaintiffs, nor the Delaware court.  Id.

Finally, the Plaintiffs argued that the Defendant should have sent a Dear Doctor Letter about the strengthened warning to all physicians.  For one thing, since the FDA had already sent a Drug Safety Communication on this topic, we are not sure what difference a Dear Doctor Letter would have made.  Regardless, the court rejected this argument because the Plaintiffs did not plead it, and they raised the alleged failure to send a Letter for the first time at the summary judgment hearing.  Id. at *5.  Moreover, on the merits, because federal law prohibits generic drug manufacturers from sending Dear Doctor Letters unilaterally, any claim based on the failure to send a Letter was preempted under Pliva v. MensingId. at *6.

It would be tempting to think that warnings-based orders like this have little impact on “failure to update” claims generally, but that would be a mistake.  Failure to read as a basis for negating warning causation is well-established nationwide, as our post here demonstrates.  Significantly, Boros is the first Delaware law decision to address this variant of warning causation.  Moreover, because generic manufacturers do not typically promote their products or otherwise communicate directly with doctors, and because physicians commonly do not read package inserts, the exceptionally clear facts of this case are likely to recur.  The Delaware court’s treatment of the law and evidence was right on the money, and other courts would be wise to follow.  Hats off to Delaware.

This post is not from the Dechert side of the blog.

“Failure to update” claims have multiple problems.  You probably already know what we are referring to.  Federal law requires that generic drug manufacturers ‎distribute their products with drug labeling that is the same as their innovator counterparts—the so-called “duty of sameness.”  A “failure to update” claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury.  Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as we pointed out here.

In addition to the preemption issues, “failure to update” claims are highly contrived.  We never saw them before the Supreme Court found most claims against generic drug manufacturers preempted by federal law, and the key principle under tort law is whether drug labeling adequately warns of known and reasonably knowable risks.  Sameness might be relevant to adequacy, but it also might not.  In this regard, “failure to update” claims are nothing more than plaintiffs’ lawyers trying to thread the eye of a needle after Mensing and Bartlett.

True, the duty of sameness does not seem all that onerous to our uneducated eyes:  Just follow the leader.  And it is not like we are talking about absolute liability.  As we have discussed, the plaintiffs still have to prove all the elements of their claims, including (but not limited to) causation.  On days when we are in this generous frame of mind, “failure to update” claims are something we can live with.

Continue Reading Warnings Causation Sinks “Failure to Update” Claim

Today’s post comes from the non-Dechert side of the DDL blog.

This week is the anniversary of the beginning of Facebook.  The question of whether Zuckerberg et al. could successfully “monetize” that platform has apparently been answered.  There are almost as many ads and push notifications as there are things that we actually care about, such as pictures and updates from friends and family.  Even worse than the ads are the political rants, stalker high school classmates, and suggestions to join stupid games.   After a nephew invited us to play Farmville for the fifth time, we unfriended him.  It was an easy call, especially since most of his entries involved home-made backyard mixed martial arts films and his f-bomb quotient would have made the makers of Scarface and Midnight Run blush.   Why isn’t there a “Dislike” button we can click?

But today we will “Like” a pair of decisions out of the Southern District of Texas.  The cases are Jackson v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9286 (S.D. Tex. Jan. 27, 2015), and Garza v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9292 (S.D. Tex. Jan. 27, 2015). The cases involve the same judge, the same defendants, and the same claim that ingestion of Reglan/metoclopramide caused tardive dyskinesia.  They were issued on the same date.  Both opinions are short, well-reasoned, and follow settled Fifth Circuit law.

Continue Reading S.D. Texas Upholds Texas Presumption of Non-liability for FDA-approved Drugs and Rejects Failure to Update Claim

Last week, the Eighth Circuit put the final seal on Pliva’s victory in Brinkley v. Pfizer, Inc., 2014 U.S. App. LEXIS 22742 (8th Cir. Dec. 2., 2014), upholding the district court’s dismissal with prejudice under Mensing and Bartlett.  The case involved a doctor who prescribed Reglan and a pharmacist who, when filling the prescription, switched it out for Pliva’s generic metoclopramide.  Id. at *2.  While the Reglan label had been changed in 2004 to add a warning on long-term use, Pliva, plaintiff claimed, failed to make the corresponding update to its label.  So she pursued a failure to update claim.

In some sense, that’s a good starting point.  By styling her failure to warn claim as a “failure to update,” Plaintiff was conceding that she could not bring a standard failure to warn claim.”  Generic manufacturers can only change their label to match a corresponding change in the branded label, and plaintiff hoped that her “failure to update” claim would avoid Mensing preemption.

But this claim had problems too, and they centered on the learned intermediary doctrine.  Pliva’s duty to warn, if any, ran to plaintiff’s prescribing doctor.  But, as plaintiff alleged, her doctor prescribed Reglan, not Pliva’s generic metoclopramide.  Consistent with that, the doctor consulted the Reglan label, not the Pliva label.  Id. at 2-3.  In short, the doctor never read Pliva’s label.  So no matter what Pliva put there, it could not have affected the doctor’s decision to prescribe the drug to plaintiff.  We lawyers call that a failure of proximate causation.

Continue Reading Learned Intermediary Doctrine Gets an Assist in Preempting a Failure to Update Claim

It’s only a small piece of what product liability claims are all about, but the Sixth Circuit in Fulgenzi v. PLIVA, Inc., No. 12-3504, slip op. (6th Cir. March 13, 2013), has ruled (creating something of a circuit split with the 5th Circuit’s nonprecedential Morris decision from last month), that “failure to update” claims are not preempted in a case involving a generic drug.  Everything else is gone, and Fulgenzi goes to great pains to state that even evidence of any other possible warning isn’t admissible, but this one claim remains.

As is typical with any court that rejects a preemption argument, Fulgenzi references a “presumption against preemption,” slip op. at 8, even though the Supreme Court majority in Mensing did not rely  on any such thing (and four justices would have eliminated it altogether).  Mensing impossibility preemption did not apply because there was nothing impossible – the updating in question had already been ordered by the FDA:

In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process . . . but it had a federal duty to do so.  As a result, compliance with federal and state duties was not just possible; it was required. Impossibility preemption is inappropriate in such a case.

Slip op. at 9 (citations omitted).

The more problematic aspect Fulgenzi is how it dealt with what we’ve always thought of as the strongest argument against failure to update, which is that under Buckman a duty to update claim is an improper disguised attempt to enforce an FDCA updating duty that doesn’t exist under federal law.  We’ve read Fulgenzi twice on this point, and we still don’t see the rationale, so we’ll let our readers noodle over it:

[T]he result of this violation does raise concerns that [plaintiff] is simply attempting to enforce a federal-law violation through state litigation.  Where, as here, the statute specifically excludes a private cause of action, 21 U.S.C. §337(a), state tort suits premised on violations of federal law may be impliedly preempted . . . if the claims “exist solely by virtue of” the regulatory scheme . . . .  Here, [plaintiff’s] suit is not even premised on violation of federal law, but rather on an independent state duty.   The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption.  The federal duty of sameness is not a “critical element” in [plaintiff’s] case.  Failure to update from one adequate warning to another would violate the FDCA, but not Ohio law.  Her suit instead relies upon the adequacy of the warnings and the causation of her injuries.

Fulgenzi, slip op. at 12-13 (emphasis original).  But state law does not have anything to do with “sameness,” one way or the other.  That’s an entirely federal concept.  That “duty” exists only by virtue of the FDCA.  For plaintiffs to substitute that duty (the only one that survives Mensing express preemption), is to put state law in the position of enforcing federal law, which the FDCA explicitly prohibits.  As even Fulgenzi is forced to admit, “violation of the federal duty of sameness is essential to [plaintiff’s] case.  Id. at 13.  Whether or not there’s a “violation” is irrelevant to §337(a), the duty is unquestionably federal.  Only the federal government may enforce it.  Whether the “same” warning is, or is not, also “adequate” under state law amounts to nothing more than coincidence.  At least that’s how we see it.

The court also rejected “purposes and objectives” preemption, holding that no generalized congressional intent to encourage generic drugs prevented any and all product liability claims against their manufacturers.  “A vague policy of encouraging use of generic drugs, untethered from the structure of the Act, is not enough to support purposes-and-objectives preemption.”  Fulgenzi, slip op. at 11.

So what’s left?  A small piece of a claim.  Apparently, after preemption is overcome, the “duty of sameness” drops from the case altogether:

On the merits, whether [defendant] has violated its federal duties is irrelevant to the adequacy of its warnings.  A jury need not know about the duty of sameness at all.

Fulgenzi, slip op. at 13.  The FDA goes unmentioned at trial (even though it is simultaneously “essential”), but the plaintiff is forbidden from challenging the “adequacy” of the generic warning under state law with anything other than the FDA-approved “update.”  Id.

So there’s not that much left, and even the duty to update claim is factually specific to this one generic drug.  We don’t know of any other generic drug litigation where there’s any factual basis for a failure to update claim.  That’s why what bothers us the most about Fulgenzi is the mess the court made when as it tries to fit something into Ohio law that has no basis in Ohio precedent.  The opinion states: “[T]here is nothing in the Ohio product-liability law inconsistent with a claim that a defendant failed to warn, even inadequately.”  Slip op. at 13.  That litodes is just the double negative way of stating that there’s not a scrap of Ohio product liability law affirmatively recognizing a viable claim for failure to give an inadequate warning.

We go on until we’re blue in the face that federal courts sitting in diversity are not supposed to predict expansions of state law that have no support in that law.  It’s not enough that no court might have had occasion to reject a novel and bizarre theory like failure to give an inadequate warning nonetheless being a basis for liability.  There must be state-law precedent somewhere affirmatively supporting a claim for a federal court to predict its adoption.  Ohio imposes a “reasonable care” statutory standard for warning claims.  Nothing supports the proposition that a concededly “inadequate” warning nonetheless constitutes “reasonable care,” and Fulgenzi cites nothing.  This double negative approach is inconsistent with Erie.

[F]ederal courts must proceed with caution when making  pronouncements about state law. Sitting in diversity, we are not commissioned to take a position regarding the advisability or fairness of the state rule to be applied, but must determine the issue as would the highest court of the state.   This Court’s proper reluctance to speculate on any trends of state law applies with special force to a plaintiff in a diversity case. . . .  When given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.

Combs v. International Insurance Co., 354 F.3d 568, 577 (6th Cir. 2004) (citations and quotation marks omitted); see Ventas, Inc. v. HCP, Inc., 647 F.3d 291, 328 n.15 (6th Cir. 2011 (quoting and following Combs); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1429 (6th Cir. 1997) (“A federal court in a diversity case is not free to engraft onto … state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits”) (quoting Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).

So completely apart from preemption, we think that Fulgenzi‘s plucking of a failure-to-give-an-inadequate-warning theory of liability from thin air is more than simply wrong – it’s a usurpation of the rights of the Ohio state courts to determine, in the first instance, what Ohio law is supposed to be.  It’s not merely a matter of causation (not being able to say “that a severely inadequate warning would never cause an injury that a moderately inadequate warning would have prevented,” slip op. at 14), it’s a matter of whether such a duty – that not giving a legally inadequate warning is required as a matter of “reasonable care” – exists in the first place.  No federal court should make that prediction in the first instance.

We’ve said it before, tort preemption makes courts do strange things; but that doesn’t make it right.

Still, what’s left, even after violence has been done to both §337(a) and Ohio law, isn’t very much.  Another “narrow gap” – this time between Mensing and Buckman must be navigated.  Slip op. at 14.

The arguments [plaintiff] makes, the proofs she offers, and the evidence she submits are all subject to limitation by preemption principles. . . .  [Plaintiff] must use the language of the 2004 FDA-approved label in her proximate-cause argument, not (or not merely) the fact of the failure to update.

Fulgenzi, slip op. at 14-15.  That’s all that’s left, and in a generic preemption case involving a different drug where there hasn’t been any failure to update, not even that.

Thus, while to some extent Fulgenzi is a hash, it’s also a tempest in a teapot – unless and until some other court in some other case involving some other product picks up that dead cat of a failure-to-give-an-inadequate-warning claim and tries to run with it.

In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts, why plaintiffs not faced with preemption never bring claims for failure to update a warning – they’re simply lousy claims. The latest example of this fact is Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).

Woods is yet another metoclopramide case – that’s the generic drug that produced PLIVA v. Mensing, 131 S. Ct. 2567 (2011). Stuck between a rock and a hard place, the plaintiff:

Argue[d] that her claims are not preempted because they are based on the generic defendants’ “failure to update” their labels to be consistent with the brand name labeling.

Woods, 2016 WL 1719550, at *1. Woods, after examining various non-binding precedents, concluded that plaintiff “has set out a narrow claim that falls outside the scope of federal preemption” – the failure to update claim involving no more than the FDA-approved labeling. Id. at *8.

OK, so take generic preemption out of the mix entirely – what happens with Woods?

Same ultimate result as if the claim had been preempted; that is to say, judgment on the pleadings for the generic defendants.

Continue Reading Yet Another Failure-To-Update Claim Bites the Dust

We have a long, 50-state survey post entitled “Don’t Forget About A Prescribing Physician’s Failure To Read Warnings,” about a subject as to which we feel strongly enough that we keep it updated on an ongoing basis.  Its proposition is simple, and powerful:  Under the learned intermediary rule, it is impossible to prove causation from purportedly inadequate drug or device labeling when the prescribing doctor to whom the material is directed did not read it.  That fact pattern happens quite often.  Physicians are smart and busy people.  Their familiarity with product risks usually comes from their training and their professional education.  Equally often, they are intimately familiar with the risks of the products they prescribe or use, and thus don’t bother reading what our clients’ FDA-approved labeling has to say.

So, if an allegedly inadequate labeling is never read, it can’t cause anything.

Well, how about physician testimony that almost, but not quite, establishes a prescribing physician’s failure to read?  The fact pattern we address today is:  Instead of denying that s/he ever read the product labels in questions, a prescriber will sometimes testify that s/he doesn’t “remember”/”recall” reading it.  Do the same causation principles apply?

The answer is, usually yes.  See Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) (“the plain language of Rule 56(c) mandates the entry of summary judgment . . . against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial”).

As long as the plaintiff retains the usual burden of proving causation, this kind of “don’t recall” testimony means that the plaintiff has more work to do to establish causation, and if the plaintiff doesn’t do that work, then the plaintiff loses, just as when the prescriber affirmatively denies having read the label.  That’s the bottom line from what appears to be the leading case on this fact pattern, Pustejovsky v. PLIVA, Inc., 623 F.3d 271 (5th Cir. 2010) (applying Texas law).  In Pustejovsky, the plaintiff’s prescribing physician “did not recall ever reading the package insert for the drug or consulting the Physician’s Desk Reference” concerning it.  Id. at 277.  While such testimony – unlike an explicit “I never read” statement – is not necessarily fatal to the plaintiff, neither does it satisfy the plaintiff’s burden of proving causation.  The prescriber’s “lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff’s] burden.”  Id.  What defeated the plaintiff’s claim in Pustejovsky was her failure to adduce any other evidence, which meant the causation element was speculative:

Lacking any evidence that [the prescriber] was aware of [defendant’s] warnings, [plaintiff] instead speculates about other ways an adequate warning might have reached [the prescriber] and altered her decision.  She suggests, for example, that a modification to [the] warning label might have come up in conversations with other physicians or been discussed at a continuing-education seminar.  Certainly, these scenarios are possible.  Ultimately, however, without any summary-judgment evidence to support them, they remain nothing more than possibilities.

Id. (emphasis added).  One “can imagine any number of scenarios,” but without affirmative evidence, none of those castles in the clouds can satisfy a plaintiff’s burden of proof.  “Unsubstantiated assertions  and unsupported speculation are not sufficient to defeat a motion for summary judgment.”  Id. (citation and quotation marks omitted).  Summary judgment affirmed.

Lewis v. Johnson & Johnson, 601 F. Appx. 205 (4th Cir. 2015) (applying Texas law), is a more recent application of Pustejovsky.  On appeal from summary judgment granted in the Pelvic Mesh MDL, the court affirmed for lack of causation evidence under Texas law.

[Plaintiff] presented no evidence that [her surgeon] relied on the warning in [defendant’s] patient brochure in deciding to prescribe the [product].  [The surgeon] testified that she did not recall whether she had a [product] patient brochure at the time of [plaintiff’s] surgery. . . .  [The surgeon] further stated that she would not have verified the accuracy of the information in the brochure.  None of this testimony establishes that [the surgeon] considered the patient brochure warning, let alone relied on it.

Id. at 208.  Following Pustejovsky, Lewis held that the plaintiff “did not offer sufficient evidence to create a dispute as to material fact regarding whether a different warning would have changed [her surgeon’s] decision to prescribe the [the product].”  Id. at 209.

In a recent case controlled by Pustejovsky the relevant testimony of the plaintiff’s surgeon was that while she “sometimes [did] read through” product labeling, she did “not recall for this case or at the time regarding this device.”  Castillo v. Boston Scientific Corp., 2020 WL 2771193, at *7 (W.D. Tex. May 28, 2020) (citations and quotation marks omitted).  Following Pustejovsky, summary judgment was granted in Castillo.  Plaintiff “has not established that a proper warning would have changed [the surgeon’s] decision” because “[h]ypothetical situations . . . do not suffice.”  Id. at *8.  “While it remains possible that [the surgeon] did review the [warnings] . . ., [plaintiff] has not presented the evidence that [the surgeon] did in fact do so.”  Id.  See also Robles v. C.R. Bard, Inc., 2015 WL 11120857, at *2 (N.D. Tex. March 23, 2015) (also following Pustejovsky and granting summary judgment based on prescriber testimony “that he does not recall whether or not he read the instructions”; with no other evidence plaintiff “cannot establish causation”).

The oldest case we’ve found holding that “do not recall” physician testimony is insufficient, without more, to establish a prima facie case of warning causation is Oppenheimer v. Sterling Drug, Inc., 219 N.E.2d 54 (Ohio App. 1964), in which the prescribing physician “specifically said-‘I don’t recall specifically reading the precautions.’”  Id. at 58.  Oppenheimer held:

His recollection was not clear as to the readings in Physicians’ Desk Reference and defendant’s literature circulated to physicians and druggists.  It can hardly be said that he relied upon anything produced by the defendant or found in the general literature.

Id. at 59.  This lack of prescriber reliance was dispositive of plaintiff’s warranty claim, which was the only claim at issue in OppenheimerId. (discussing reliance element of warranty).

Sherman v. Pfizer, Inc., 440 P.3d 1016 (Wash. App. 2019), is substantially more recent state appellate authority than Oppenheimer.  In Sherman, the plaintiff’s prescriber testified that he “did not read package inserts and did not recall ever reading a package insert.”  Id. at 1023.  That testimony was fatal to the plaintiff’s inadequate warning claims.

Based on these undisputed facts, . . . Defendants’ alleged failure to update the package inserts cannot be the proximate cause of [plaintiff’s] condition as a matter of law because even if they had updated the package inserts, [the prescriber] would not have read them.

Id. (citation omitted).

Most recently, in Russell v. Ethicon, Inc., 2020 WL 5993774 (M.D. Pa. Oct. 9, 2020), the implanting surgeon’s “admissions that he does not recall reading the [instructions for use] and that he does not use the IFU when consenting patients are fatal to [plaintiff’s warning] claim.”  Id. at *6.  This failure to recall did not meet the plaintiff’s burden of proof.  “Plaintiff argues that the mere fact that [her surgeon] did not remember whether he had read the IFU creates a genuine dispute of material fact.  It does not.”  Id.

[The surgeon’s] lack of memory, of course, does not preclude the possibility that he read these materials, but neither can it sustain Plaintiff’s] burden.  Plaintiff was not foreclosed from pointing to contrary evidence in the record that would suggest that [her surgeon] did read and rely upon [defendant’s] inadequate warning, but she has failed to do so.  Therefore, even if [defendant’s] warning was inadequate, Plaintiff has not provided evidence that the warning was a proximate cause of her injuries.  Accordingly, the Court grants summary judgment as to the failure to warn claims.

Id. (quotation marks and footnotes citing Pustejovsky omitted).  See Ebert v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2020 WL 2332060, at *7 (E.D. Pa. May 11, 2020) (surgeon could not “recall whether he read [the product label] before implanting the [product]”; “even assuming that the warnings were inadequate, more detailed warnings . . . would have made no difference”) (we blogged about Ebert here).

Another recent case along the same lines is Morris v. Biomet, Inc., 2020 WL 5849482, at *10 (D. Md. Sept. 30, 2020), where the plaintiff’s surgeon “did not specifically recall whether he read the IFU prior to Plaintiff’s surgery” (citation omitted).  “Because Plaintiff cannot establish that [her surgeon] would have relied on more adequate warnings, she cannot prove her failure to warn claims.”  Id.

Similarly, in In re Wright Medical Technology Inc., Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306 (N.D. Ga. 2015) (applying Utah law), the implanting surgeon testified that he did not “recall” ever reading the product’s package insert.  Id. at 1360.  In the absence of any affirmative evidence of some other way the allegedly inadequate information could have affected the plaintiff’s course of treatment, causation was not proven:

The question here is whether the learned intermediary doctrine precludes Plaintiff’s failure to warn claim based on the package insert warning.  The Court concludes that it does.  [Plaintiff’s surgeon] was unequivocal in his testimony about how he determined the risks and benefits of devices he implants.  He prefers to “educate himself” on the product, and review the studies and what went into a design.  He applied that same approach when evaluating the implanted device at issue in this case.  [He] did not recall reading the insert included in the packaging.

Id.  Thus “the evidence here does not support a failure to warn claim based on the warning provided for the implant at issue in this case.”  Id.

In In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices & Products Liability Litigation, 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018) (applying Georgia law), the “[p]laintiff fail[ed] to raise a genuine issue of material fact on the proximate causation element of . . . failure to warn claims.”  Id. at *4.  This result was required because the implanting surgeon “could not recall whether he read the [product] IFU.  If he could not recall reading [it], he could not have relied upon the warnings and other information set forth in it.”  Id. at *3 n.2 (citation omitted).

In In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, 2015 WL 5468712 (M.D. Ga. Sept. 16, 2015), the court, applying Arkansas law, granted summary judgment against warning claims where the implanting surgeon “does not recall reading the . . . product information data sheet, and he does not recall speaking with a [sales] representative about [the product].”  Id. at *1.  Not only did this testimony fail to establish causation, it also rebutted the Arkansas heeding presumption:

[Plaintiff] did not point to any evidence that [her surgeon] would have taken a different approach had [defendant] provided additional warnings.  [Plaintiff] argues that the Court should presume that [the surgeon] would have read and heeded adequate warnings in the product insert data sheet.  But it is undisputed that [the surgeon] did not recall reading the . . . product insert data sheet. . . .  Given this evidence − and the lack of any evidence that [the surgeon] would have altered his treatment . . . had the [product] warnings been different – [plaintiff’s] failure to warn claim fails.

Id. at *2 (citation omitted).  See In re C.R. Bard, Inc., 2013 WL 5591948, at *6 (S.D.W. Va. June 4, 2013) (implanter remembered neither the product’s instructions for use nor reviewing same; summary judgment granted for lack of evidence that the surgeon “would have altered his conduct if adequate warnings were given”) (applying Mississippi law).

In California, the plaintiff in Latiolais v. Merck & Co., 2007 WL 5861354 (C.D. Cal. Feb. 6, 2007), aff’d, 302 F. Appx. 756 (9th Cir. 2008), lost where the prescriber’s “do not recall” testimony was paired with a statement of non-reliance.

[The prescriber] could not recall receiving any information from [defendant] concerning [the drug] that affected his decision to prescribe it to Decedent.  [He] stated that he saw sales representatives from drug companies only “rarely” and could not recall any interaction with [defendant’s] representative. . . .  He could not recall being influenced by any information from [defendant] or any other source concerning [the drug, and] stated that he could not recall if he ever read the package insert regarding [the drug], but, most importantly, stated conclusively that the inserts played no role in his decision to prescribe [the drug] to Decedent.

Id. at *2 (citations omitted).  This do not recall “minus” (as opposed to the “plus” discussed in Pustejovsky) evidence completely failed to establish causation.  Id. at *3 (the prescriber “could not recall if he ever read the package insert, or warnings, regarding [the drug].  Further, [he] stated he could not recall being influenced in this regard by any information from [defendant]”).

Earlier, Harris v. McNeil Pharmaceutical, 2000 WL 33339657 (D.N.D. Sept. 5, 2000), reached a similar conclusion.  The facts were unfortunate – the plaintiff was a physician who was also a drug addict and who “self-prescribed” the drug in question.  Id. at *1-2.  He answered “no” to whether he “recall[ed] . . . reviewing any information about the drug having a potential for abuse or dependence.”  Id. at *2.  Plaintiff therefore lost his case for “lack of causation.”  Id. at *5.

[Plaintiff] testified that he does not recall reading the package insert. . . .  He does not recall reading anything about the mechanism of action . . . or a discussion of the drug having a potential for abuse or dependence, until after he recognized he was addicted.  Nor does [plaintiff] recall reading the package insert portion which [discussed drug dependency], or that portion which [discusses prior opioid use]. . . .

Proximate cause is such an element [essential to plaintiff’s case].  It is this court’s opinion that [plaintiff’s] failure to review the contents of the package insert pertaining to precautions and dependency potential accompanying the [drug] provided to him is fatal to his claims under all theories of liability.

Id. at *4 (citation and footnote omitted).

Finally, what is the kind of additional evidence that, when added to prescriber “do not recall” testimony, can satisfy a plaintiff’s burden of proof?  We’re not going to do the other side’s research for them, but In re Taxotere (Docetaxel) Products Liability Litigation, 2020 WL 4228387 (E.D. La. July 23, 2020), is illustrative.  While the prescriber “could not recall reading the [product’s] label,” the plaintiff adduced evidence that the prescriber “stays informed of drug labels through several third-party sites.”  Id. at *1-2.  That was enough to create a fact question.

Thus, while “not recall reading” testimony is obviously not as definitive as “did not read” testimony, it often can and should be dispositive, given the usual burden of proof, unless the plaintiff can develop some other affirmative testimony that establishes a causal link to purportedly inadequate labeling information.

Most of the controversy in the recent decision, Hill v. Bayer Corp., 2020 WL 5367334 (E.D. Mich. Sept. 8, 2020), revolved around whether the plaintiff could assert a cause of action for failure to report adverse product events to the FDA.  Like the great majority of decisions (particularly since Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. Dec. 18, 2018), exposed Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Jan. 10, 2013) (en banc), as an erroneous decision) Hill refused to allow such a claim.

Plaintiff’s chief problem in Hill was that the contraceptive device she was suing over was FDA pre-market approved, thus providing the defendant with a strong preemption defense.  As a purported “parallel” claim that could escape preemption, the plaintiff in Hill alleged failure-to-report as a “negligent failure-to-warn”:

Despite the heading “negligent failure-to-warn,” the Amended Complaint cites to a lengthy list of alleged federal regulatory violations, the vast majority of which do not involve warning requirements at all, but rather involve the alleged failure to make certain reports including adverse events to the FDA.

2020 WL 5367334, at *4.

Hill wasn’t buying what the plaintiff was selling.  “The law is well established that there is no parallel federal requirement that [defendant] had a duty to warn the general public or the medical community, and thus, those claims are expressly preempted because they are different from, or in addition to,’ the Medical Device Amendments (“MDA”) requirements.”  Id. (citations and quotation marks omitted).  Any duty to report was created solely by the Food, Drug & Cosmetic Act (“FDCA”):

[I]t is the Federal Government, not private litigants who are authorized to file suit for noncompliance with the medical device provisions. . . .  [A] state law tort claim that is “a disguised fraud on the FDA” claim is preempted. . . .  That is exactly what [plaintiff] seeks to do here: to hold [defendant] liable for alleged misrepresentations and withholding of information to the FDA.

Id. at *5 (citations and quotation marks omitted).

The learned intermediary rule is a traditional restriction on warning claims involving prescription medical products, and that rule means that the FDA is not a common-law learned intermediary.

Under the learned intermediary rule, the physician is the proper recipient of necessary information or warnings, not plaintiff.  Thus, under Michigan law, any duty in this case would be one owed to [plaintiff’s] physicians, not [plaintiff] herself, and not the FDA.

Id. at *7 (citations and quotation marks omitted).  Nice and simple – where the learned intermediary rule applies, there is no common-law duty to warn anyone else, including the FDA.  Because plaintiff “has not alleged any Michigan requirement that a manufacturer report adverse events to the FDA” but instead “relies solely on [defendant’s] alleged failure to warn the FDA of adverse events in support of her failure to warn claim,” the claim is preempted.  Id.

Hill is representative of most recent precedent (except for the case we discussed here).  Just since August, three other cases had held reporting-based warning claims preempted when asserted against manufacturers of PMA devices.  In Bayer Corp. v. Leach, ___ N.E.3d ___, 2020 WL 4811506 (Ind. App. Aug. 19, 2020) (discussed here), the court held:

[E]ven assuming that [defendant] failed to comply with federal reporting requirements, other federal law nevertheless required that [defendant] use the approved labeling and packaging.  Under the MDA, a state cannot impose a different or additional requirement.  Thus, the claims that [defendant] is liable for a failure to . . . are expressly preempted.

Id. at *10 (regulatory citations omitted).

Next, in Noel v. Bayer Corp., 2020 WL 5038782 (D. Mont. Aug. 26, 2020) (discussed here), failure-to-report claims failed under Montana law.  First, “no FDA requirement for Bayer to report consumer complaints directly to healthcare providers and consumers or to update its warnings and labeling.”  Id. at *4.  Second, “Montana law provides no such parallel duty” to the federal requirement that “device manufacturers must report any incident to the FDA where their device may have caused or contributed to a death or serious injury.”  Id. (citation and quotation marks omitted).  Under the learned intermediary rule:

A government regulator is not a foreseeable user or consumer of a product.  Nor is it a healthcare professional responsible for a patient’s care.  In neither case did the Montana Supreme Court hold that a manufacturer must warn the FDA (or government regulators generally) of known dangers.

Id. (emphasis original).

Likewise, Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020) (discussed here), joined the “[m]any courts [that] have found claims based on alleged reporting failures preempted.”  Id. at *7 (citations omitted).  Given the learned intermediary rule, Conley rejected the plaintiff’s argument and held that Pennsylvania common law imposed no “general[] . . . duty to warn third parties.”  Id. at *5-6 nn. 5-6.  Without any parallel common-law duty preemption could not be avoided.  Thus, the reporting claim in Conley “failed to state a parallel claim” and was “preempted.”  Id. at *7.

Depending on how a court chooses to view the issue, a failure-to-report claim against a PMA device manufacturer can be expressly preempted (Leach, Conley), impliedly preempted (Noel), or both (Hill).

Recently, largely related to the dubious pleasure of home ownership, we have had multiple occasions on which we were forced to shrug our shoulders and proclaim, “Nothing’s perfect.”  To wit, we recently noticed a small wet spot on our bedroom ceiling.  The roofing company discovered that the corresponding section of the roof was too shallow to be shingled and replaced the section with the correct material.  That spot dried up and stayed dry, but we walked into our bedroom during the next big storm to find water dripping from a recessed light in a different location under the brand-new section of roof.  Nothing’s perfect.

We could go on (trust us).  But we will move, with a similar sense of resignation, to today’s case.  Vardouniotis v. Pfizer, Inc., 2020 WL 3890928 (N.Y. Sup. July 7, 2020), begins as a rare and lovely example of a court applying the correct standard to dismiss a failure-to-warn claim on federal preemption grounds.  In Vardouniotis, the plaintiff took the defendant’s prescription drug to help her quit smoking.  She alleged that it caused her to suffer injuries that included a number of symptoms related to pain in her back, neck, abdomen, legs, and hips, along with movement disorders, “difficulty lifting items, persistent exhaustion, labored breathing, depression; and anxiety.”  Vardouniotis, 2020 WL 3890928 at *1.  She asserted the usual panoply of product liability claims, including a claim that the defendant had not adequately warned of the risks of “movement disorders, serious injury, or death.”  Id.  In its motion to dismiss, the defendant argued that the warnings claims were preempted by the FDCA.

The court explained that, to “update a label without prior FDA approval, a manufacturer must comply with the ‘changes being effected’ (‘CBE’) regulation, which allows manufacturers to add or strengthen label warnings unilaterally to “reflect newly acquired information.”  Id. at *2, citing 21 CFR § 314.70(c)(6)(iii).  The only time the FDCA and its implementing regulations do not preempt a state law failure-to-warn claim is when the manufacturer could have changed the label pursuant to the CBE regulation.  Under that circumstance, “the burden shifts to the party asserting a preemption defense to demonstrate that there is clear evidence that the FDA would not have approved” the label change.  Id. at *2-3 (citation omitted).  This is the Levine “clear evidence” rule that has confounded courts – and produced singularly bad decisions – since 2009.  Not so here.

The defendant argued that the plaintiff had not alleged that the defendant had “information that . . . revealed risks of a different type or severity or frequency than warned of in the . . . label and [that the defendant] had not previously submitted to the FDA.”  Id. at *3.  In other words, according to the defendant, the plaintiff had not alleged the existence of “newly acquired information” that would have triggered the defendant’s ability to change the label without prior FDA approval.  The plaintiff countered with citations to newspaper articles and journal publications describing risks not listed in the label, and she argued that she didn’t know, before discovery, whether or not those risks were identified to the FDA as part of the defendant’s New Drug Application.

The court commented that, although the plaintiff “cite[d] newspaper articles in her memorandum of law, [the] articles were not annexed to the complaint or her opposition to [the defendant’s] motion to dismiss.” Id.  The court also declined to take judicial notice of “materials derived from a Federal Aviation Administration website or a Wall Street Journal article,” because “[j]udicial notice of facts is reserved for matters of common knowledge, well-established and settled.”  Moreover, “[judicial notice of a fact may not properly be based upon a factual assertion simply because the assertion is contained in a newspaper article.” Id. (internal punctuation and citations omitted).“  Thus,” the court stated, “the plaintiff has not identified any newly acquired information that could have justified [the defendant’s] revising the . . . label unilaterally through the CBE regulation without FDA approval.”  Id.  Nor was the court swayed by the plaintiff’s argument that she needed discovery to defeat preemption, commenting that “the mere hope that discovery may reveal facts essential to justify opposition does not warrant denial [of a motion to dismiss].”  Id. at *4 (internal punctuation and citation omitted).  The court held, “As the plaintiff has failed to make a sufficient showing that such facts could be obtained in discovery, the plaintiff’s failure to warn claims are dismissed.” Id.

We remember the days leading up to the Levine decision and our disappointment when the decision came down.  In the ensuing years, we have been frustrated, far more often than not, by courts’ refusal or inability to approach preemption motion-to-dismiss decisions with open-minded rigor.  It’s pretty simple: if a plaintiff properly alleges that a manufacturer failed to change a label in the face of “newly acquired information” about a new or heightened risk, she may be able to defeat dismissal on preemption grounds.  Otherwise, her failure-to-warn claims should be dismissed as preempted by federal law.  So many courts get it wrong, and we were delighted to read a decision that gets it right.

But nothing’s perfect.  The court granted the defendant’s motion with respect to some of the plaintiff’s remaining claims and denied it with respect to others.  But here is where the decision really went off the rails: the court held that the plaintiff had adequately pled her negligence claim when she alleged that she was injured as a result of the defendant’s “failure to adequately test” its drug.  The court also declined to dismiss the plaintiff’s gross negligence and “wanton and malicious conduct” claims based on the same allegations.  Here’s the thing: our “duty to test” cheat sheet includes four cases, including a Second Circuit case, holding that there is no such duty under New York law.  The Vardouniotis court didn’t even discuss the issue when it allowed these claims to proceed.  We are disturbed by this.  The concept of “failure to test” intrudes on territory that is framed by FDA’s comprehensive regulatory scheme.  Our drug and device clients don’t need common-law “failure to test” claims, especially in jurisdictions that have already rejected them.

Nevertheless, we love the preemption portion of this decision. We will continue to keep you posted on the good, the bad, and the merely imperfect.  In the meantime, stay safe out there.