No writer made as strong an impression on us in high school as Albert Camus. The opening of The Stranger is arresting: “Mother died today. Or maybe it was yesterday, I don’t know.” Our teacher pronounced The Plague to be an even better book, and he often quoted the bit about how we had “to be content to live only for the day, alone under the vast indifference of the sky.” [One of our time entries for yesterday is very similar.] Now, in the days of the coronavirus, it is hard not to bump into borrowed lines from The Plague, especially this one: “There are more things to admire in men than despise.” Perhaps Camus would rethink that after wandering down supermarket aisles denuded of toilet paper.

Camus has put us in the mood for absurdity, so let’s take a look at a pro se product liability lawsuit attempting to squeeze into the overused, incoherent, narrow-gap, Riegel “parallel claim” exception. In Jacob v. Mentor Worldwide, LLC, 2019 WL 3229010 (M.D. Fla. July 17, 2019), the plaintiff alleged that a breast implant ruptured and caused her to suffer from a “lupus-like syndrome.” The plaintiff had an M.D. after her name, but we don’t know what sort of doctor she was. What we do know is that she wasn’t much of a lawyer and, as the saying goes, had a fool for a client. The complaint included causes of action for negligence, failure to warn (of the foreign country origin and of the risk of failure), and manufacturing defect. The defendant, represented by actual lawyers, moved to dismiss on the grounds of express and implied preemption.

In responding to the motion, the plaintiff argued that she was adversely affected by the implants, that, as a doctor, she could attest to the harm she suffered, that the implants were unduly porous, and that the defendant’s failure to disclose the risk of syndromes mimicking connective tissues disease led to a misdiagnosis of her condition. What does any of that have to do with preemption? Not a thing. That made life easy for the court: “Defendant is correct that Plaintiff’s claims are the extent that Plaintiff is seeking to recover for Defendant’s alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA. Similarly, Defendant is correct that Plaintiff’s claims are preempted to the extent that Plaintiff is seeking to enforce federal requirements that are not grounded in traditional state tort law.”

The problem for the plaintiff is that all her claims fell into those preempted categories. Her claims talk about failures to warn the public, doctors, and the FDA (can you say Buckman?) and, most obviously preempted of all, failures to “revise the product labeling” and communicate the “true rate” of adverse events.

Moreover, the court was irked by the plaintiff’s wholesale failure to comply with the Federal Rules of Civil Procedure. Rule 8 insists on “short and plain” statements of jurisdictional bases and substantive claims. Each allegation must be “simple, concise, and direct.” Apparently, the plaintiff’s prose flunked these requirements. (She should have read Camus – talk about simple, concise, and direct!). Rule 10 requires numbered paragraphs, and the plaintiff did not even get that right.

The court gave the plaintiff 28 days to amend her complaint, but ordered that any claim that “seeks to recover for Defendant’s alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA, or seeks to enforce federal requirements that are not grounded in traditional state-tort law,” is dismissed with prejudice.

So the plaintiff was free to try again. That possibility puts us in mind of another work by Camus, The Rebel. The central image of that work (a philosophical investigation, not a novel) is the myth of Sisyphus.

In the meantime, we’ll leave you with another quote from The Plague: “What’s true of all the evils in the world is true of plague as well. It helps men to rise above themselves.”

Isn’t enough for standing that is.  And, likely not enough for plaintiff’s case to survive, but that question was left for another day.  We’ve done a few posts on “slack fill” which is defined by the FDA as the difference between the capacity of a container and the volume of product inside.  Slack fill lawsuits have been filed against food and beverage makers, and OTC drug manufacturers, who leave empty space in a container.  The reasons for such empty space could be, for example, to protect the contents or to comply with shipping requirements.  But slack fill is acceptable so long as the container or packaging is not misleading – it contains the quantity, the product weight, the number of servings, etc.

Today’s case is similar to a slack fill case, but also sort of the opposite.  Instead of empty space being the issue, too much product is what the plaintiff in Williamson v. Genentech, Inc., 2020 WL 1281532 (N.D. Cal. Mar. 18, 2020) was complaining about.  Not slack fill but excess fill.  The problem was, he really didn’t have a problem.

Plaintiff was diagnosed with follicular lymphoma and prescribed a medication that was sold in single use vials.  For each round of treatment, plaintiff was prescribed approximately 770 to 780 milligrams of the drug.  Defendant manufactured the drug in 100 mg and 500 mg vials.  So, for each treatment, the hospital had to use a combination of vials totaling 800 mgs, meaning that there were 20-30 mgs that plaintiff did not receive – wasted medication.  Id. at *1.

Plaintiff filed a purported class action alleging that the vials sold by defendant resulted in wasted medication and therefore violated California’s Unfair Competition Law (“UCL”) because class members were forced to purchase more medication than they could use.  Id. at *2.  The case was removed to federal court the Class Action Fairness Act (“CAFA”).  After which, the court sua sponte raised the question of whether it had subject matter jurisdiction – or phrased differently, whether plaintiff had Article III standing to bring his claim.  The court’s concern was whether plaintiff had alleged an injury in fact.  For standing, an injury in fact must be “particularized and concrete,” not “conjectural or hypothetical.”  Id. at *2.  The court also noted that the UCL similarly requires a plaintiff to “allege that he has suffered injury in fact and has lost money or property as a result of a violation.”  Id.

The only out-of-pocket cost to the plaintiff for his treatments was a single payment of $231.15 in March 2017.  But nowhere in his complaint did plaintiff allege that his payment would have been different (less) if the amount of wasted medication was less.  In fact, in his briefing on subject matter jurisdiction, plaintiff clarified that the payment was actually the remaining amount of his insurance deductible and was not tied to the cost of the medication at all and would not have been different if less medicine was dispensed.  Id. at *3.  Therefore, plaintiff had no factual support for his allegation of financial injury.

Instead, plaintiff argued that he could establish standing based on California’s collateral source rule.  Under the collateral source rule, a defendant’s liability for a plaintiff’s financial damages is not reduced by any payments that the plaintiff receives as to those very same damages from a third-party source. This happens most often in connection with a plaintiff’s medical bills.  While the plaintiff’s insurance pays all or most of those bills, the defendant remains liable to plaintiff for the entire amount.  Clearly not a defense favorite as it runs counter to a core purpose of tort law, which is to compensate plaintiffs for damages actually suffered.  So the plaintiff gets a double recovery—once from the collateral source and once from the defendant.

Plaintiff here tried to take this one step further.  His argument was that the collateral source rule allowed him “to recover the entire amount his insurance company paid on his behalf for wasted medicine due to the absence of a smaller vial size.”  Id. at *4.  But the court looked at what the UCL requires for a claim of restitution –

A restitution order against a defendant [ ] requires both that money or property have been lost by a plaintiff, on the one hand, and that it have been acquired by a defendant, on the other.

Id. (citation omitted, emphasis in original).   By definition, restitution is designed to return the status quo.  To return to plaintiff something that he owned that defendant took by means of unfair competition.  Here plaintiff isn’t out anything, by his own admission.  So there is nothing to be returned.  “The collateral source rule does not allow Plaintiff to recover as restitution monies his insurance company paid on his behalf.”  Id. at *5.

In each case cited by plaintiff, the plaintiff had sustained an injury (i.e. stolen art, damage boat) for which he was insured and received compensation from the insurance company.  But none of those cases helped plaintiff here.  First, none concerned Article III standing.  Second, in each the plaintiff was able to allege he suffered the damages for which recovery was sought.  In Williamson, however, plaintiff’s only possible injury was being forced to pay for more medicine than he needed.  But plaintiff conceded he did not in fact suffer that injury.

The rule does not apply where a person cannot plead he suffered the damages for which recovery is sought.  It is thus unsurprising that no court has used the collateral source rule to find Article III standing. This Court is not persuaded that it should be the first.

Id. at *6.

While the court’s analysis led it to conclude that it did not have subject matter jurisdiction, the same analysis should support a finding that plaintiff also doesn’t have statutory standing under the UCL.  The federal court left that question for the state court upon remand “should Mr. Williamson decide to pursue his claim.”  Id.  A word of caution perhaps?  Hopefully it is heeded.  Because sometimes too much of something isn’t a problem at all.

The advent of generic preemption in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (“Mensing”), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (“Bartlett”), left plaintiffs who took generic drugs scrambling to invent bizarre, novel, and in some cases dangerous supposed causes of action.  Before it went under, the erstwhile metoclopramide litigation (which produced Mensing itself) generated a wave of innovator liability claims – thankfully mostly unsuccessful, and allegations concerning failure to update generic labels.  The latter was more successful in avoiding preemption but never got anywhere on the merits because it was simply an nonviable cause of action..

Another batch of plaintiffs left high and dry were those claiming injury from taking generic amiodarone.  They have tried to squirm around preemption in essentially three ways.  Theory one is that the generic manufacturers themselves promoted off-label use.  Theory two is that they failed to ensure than an FDA-mandated medication guide actually made it into the hands of patients.  Theory three is that generics benefited from the original branded manufacturer’s off-label promotion years earlier, and thus had some obligation to correct lingering misimpressions in the medical community left by that promotion.

We now count sixteen amiodarone cases in our generic preemption scorecard.  There was one hot spot in Texas that allowed some of these claims to escape preemption on the pleadings, but those cases failed on the merits when plaintiffs failed to find any evidence of any FDCA violations.  See Mitchell v. Wyeth Pharmaceuticals, Inc., 356 F. Supp.3d 634, 639 (W.D. Tex. 2018); Priest v. Sandoz, Inc., 2017 WL 7172504, at *11 (Mag. W.D. Tex. Dec. 28, 2017), adopted, 2018 WL 582532 (W.D. Tex. Jan. 17, 2018).

The other amiodarone cases have failed miserably at the outset.  What lessons can they teach us?

First, all claims that seek to change warnings concerning generic drugs, however, they’re pleaded – read, disguised – by plaintiffs are preempted.  “[W]hen the FDA has made a conclusive determination, positive or negative, as to the existence of a link between the drug at issue and some adverse health consequence, state law cannot mandate that a manufacturer include additional warnings beyond those that the FDA has determined to be appropriate to the risk.”  Frei v. Taro Pharmaceuticals U.S.A., Inc., ___ F. Supp.3d ___, 2020 WL 1165975, at *4 (S.D.N.Y. March 10, 2020) (citation and quotation marks omitted).  See also Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152, 1171 (E.D. Cal. Feb. 14, 2019) (“To the extent that these claims depend on [defendant] providing or communicating a warning that differs from the FDA approved label . . ., Mensing requires preemption and dismissal.”); Collette v. Wyeth Pharmaceuticals, Inc., 2018 WL 1258105, at *1 (N.D. Cal. March 12, 2018) (warning claims preempted; all other allegations too vague and must be repleaded); Bean v. Upsher-Smith Pharmaceuticals, Inc., 2017 WL 4348330, at *5 (D.S.C. Sept. 29, 2017) (“Defendants could not have changed the content of the warning label or Medication Guide and could not have disseminated additional warnings regarding ‘off-label’ use without violating federal law, [so] each of Plaintiff’s claims premised on Defendants’ alleged failure to warn is due to be dismissed as preempted.”), aff’d, 765 F. Appx. 934 (4th Cir. 2019).

Even of the lousiest case of the bunch, Arters v. Sandoz, Inc., 921 F. Supp.2d 813 (S.D. Ohio 2013), found warning claims, involving Dear Health Care Provider letters, preempted:

[Plaintiffs] claim that . . . defendants have a duty to warn consumers and physicians of known dangers of amiodarone in other ways.  Plaintiffs argue that defendants should have taken steps other than changing the drugs label . . . to “adequately warn healthcare providers or the FDA of all adverse event reports and all warnings mandated by the FDA.”  The plaintiffs in Mensing made a similar argument, that the generic manufacturers could have used “Dear Doctor” letters. . . .  A generic drug manufacturer who warns of risks not present in the approved label or strengthens the warning through “dear doctor” letters or other means creates labeling that is not consistent with the approved label, and is thus inconsistent with the FDCA.

Id. at 819.  See also Frei, 2020 WL 1165975, at *5 (defendant “could not have disseminated post-marketing warnings inconsistent with [branded] warnings and labeling − approved by the FDA − without violating federal law, and also could not have disseminated alternative post-marketing warnings without violating federal law, plaintiffs’ claims are preempted”); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *9 (N.D. Ala. Oct. 31, 2013) (throwing out “Dear Doctor” letter claim as “wholly preempted” under Mensing and Bartlett).  That’s lesson number one, and that’s pretty obvious.

Even if these labeling claims weren’t preempted, they have serious problems – like adequacy as a matter of law.  In Marroquin, the branded manufacturer the drug beat an unpreempted innovator liability claim on this basis:

[T]he FDA label clearly states that [the drug] is approved to treat two serious heart conditions and it is a drug of last resort because of its potentially fatal toxicities.  More than once, pulmonary toxicity is clearly and expressly identified as the most dangerous toxicity/potential side effect.  Percentages of those who experience pulmonary toxicity and the percentage of those who suffer fatal pulmonary toxicity is provided.  Importantly, there is nearly two pages of warnings/information devoted entirely to pulmonary toxicity.  These warnings are clear, do not appear to be inconspicuous, and appear to warn of the exact danger that tragically befell [the decedent].  Without elucidation from [plaintiff], the warning is adequate.

367 F. Supp.3d at 1162-63.  So lesson number two, innovator liability can be beat the same way as any other warning claim.

Arters was more indulgent of plaintiff’s off-label promotion claims, claiming – with no support whatever – that the promoted off-label use was somehow “in violation of [state] law,” 921 F. Supp.2d at 820.  Other decisions took a closer look at such claims and found them wanting.  Off-label promotion allegations were recognized as just one more form of preempted warning/design claim in a second opinion in StephensArters predated Bartlett, so since Bartlett claims that a drug was “not reasonably fit for [an] off-label purpose” were preempted as either a design defect or stop selling claim.  Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp. 3d 1246, 1250 (N.D. Ala. 2014).

Further, most courts recognize that allegations of “inadequate post-marketing instruction” about off-label use are preempted as “a classic ‘failure to warn’ claim, despite plaintiffs’ representations otherwise.”  Id. at 1251.

[T]o the extent those [off-label promotion] claims are not abandoned, they are due to be dismissed as preempted under Mensing and Bartlett because [defendant] could not have changed the content of the warning labels or Medication Guide and could not have disseminated additional warnings regarding “off-label” use without violating federal law.

McLeod v. Sandoz, Inc., 2017 WL 1196801, at *5 (D.S.C. March 31, 2017).  “[A]llegations claim that Defendants’ alleged [off-label] promotion resulted in failure to properly warn and hence are preempted by federal law.”  Connolly v. Sandoz Pharmaceuticals Corp., 2014 WL 12480025, at *6 (N.D. Ga. Dec. 23, 2014) (footnote omitted).  Further:

Plaintiffs’ claims of negligence and negligence per se based on the alleged “off-label” promotion of amiodarone are impliedly preempted under Buckman because the duties Plaintiffs allege [defendant] breached regarding “off-label” promotion exist solely under the FDCA.

McLeod, 2017 WL 1196801, at *7.  Thus, an off-label promotion claim concerning an otherwise non-defective drug is “preempted and cannot succeed as a matter of law.”  Moore v. Zydus Pharmaceuticals (USA), Inc., 277 F. Supp.3d 873, 884 (E.D. Ky. 2017).  Lesson three, use Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) (“Buckman“) to beat claims that plaintiffs crib from FDA regulations.

Eventually plaintiffs stopped claiming that the generic manufacturers themselves engaged in off-label promotion, and shifted to alleging that they had some sort of duty to correct or ameliorate the effects on the medical community of prior off-label promotion committed years earlier by the original branded manufacturer.  In Bean, this latest version of an off-label promotion claim also failed.

Plaintiff’s negligence claims based on the alleged “off-label” promotion of amiodarone are impliedly preempted under Buckman because the duties Plaintiff alleges Defendants breached regarding “off-label” promotion exist solely under the FDCA. Plaintiff has not directed the Court to any . . . state law causes of action that parallel the federal safety requirements limiting the “off-label” promotion of drugs.  Plaintiff’s claim for “off-label” promotion of amiodarone would not exist in the absence of the FDCA.  Accordingly, Plaintiff’s claim for negligence and negligence per se based on Defendants’ alleged “off-label” promotion of amiodarone . . . is impliedly preempted under Buckman and due to be dismissed.

2017 WL 4348330, at *7.  See McLeod v. Sandoz, Inc., 2018 WL 1456739, at *4 (D.S.C. March 23, 2018) (“McLeod II”) (dismissing amended complaint “for the reasons stated” in Bean).

Similarly, Frei, 2020 WL 1165975, held that any duty to “counteract” someone else’s prior off-label promotion failed.  For one thing, it was preempted.  Under Mensing there is no way a generic manufacturer could address prior off-label promotion without changing its label.  “[E]ach alleged cause of action requires [defendant] to either change the labeling for amiodarone, change its design or formation, exit the market, or accept state tort liability.”  Id. at *6 (quoting Bean).  Under Buckman “the duties [plaintiffs allege defendant] breached regarding off-label promotion exist solely under the FDCA.”  Id. (also quoting Bean).  Lesson four is not to let off-label promotion claims off the hook, since the label itself would not exist without the FDCA.

Amiodarone allegations concerning medication guides first surfaced in Stephens, which pointed out why such claims don’t work.  First, FDA “regulations require that Medication Guides be provided by a manufacturer to the distributor of a medication, not the end user.”  Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp.3d 1246, 1252 (N.D. Ala. 2014).  The manufacturer need only provide guides “in sufficient number” or the “means to produce” them to “distributors, packers, or authorized dispensers” – not end users.  21 C.F.R. §208.24(b)(1-2).  “Critically, the regulation does not obligate a manufacturer to provide medication guides directly to patients or their agents.”  Frei, 2020 WL 1165975, at *5.  See Mitchell v. Wyeth Pharmaceuticals, Inc., 356 F. Supp.3d 634, 638 (W.D. Tex. 2018) (“contrary to Plaintiff’s contention, does not place a duty upon [a manufacturer] to take steps to ensure that the Medication Guides are distributed to patients beyond providing them in ‘sufficient numbers’ to distributors, packers, and authorized dispensers”); Moore v. Zydus Pharmaceuticals (USA), Inc., 277 F. Supp.3d 873, 880 (E.D. Ky. 2017).  “[A]t the time a prescription drug is dispensed, it is the pharmacy (or authorized dispenser) that must ‘provide a Medication Guide directly to each patient,’ not the manufacturer of the drug.”  Id. (quoting regulation).  Lesson five is to study plaintiffs’ regulatory claims closely.  Usually, the FDA regulations don’t stand for what plaintiffs claim.

Second, there is no corresponding state-law duty to circulate medication guides.  Thus, a “claim for noncompliance with the federal regulation is preempted pursuant to Buckman.”  Connolly v. Sandoz Pharmaceuticals Corp., 2014 WL 12480025, at *5 (N.D. Ga. Dec. 23, 2014).  “Because the requirement to provide a Medication Guide . . . is based solely in the requirements of the FDCA . . ., and there is no parallel duty . . . under [state] law, Plaintiff’s claims based upon failure to provide a Medication Guide are preempted” under BuckmanBean, 2017 WL 4348330, at *7.  Time and time again, medication guide claims in amiodarone cases have fallen to Buckman preemption:

Although plaintiffs couch their failure to warn claims in traditional state tort law, it is clear the existence of the FDA’s medication guide regulation is the gravamen of these claims.  There is no question [the] amiodarone medication guide is a “critical element” in this case. . . .  Moreover, plaintiffs do not identify a parallel state law requiring [defendant] to make available to distributors an amiodarone medication guide.  And when a plaintiff’s claims “exist solely by virtue of the FDCA . . . requirements,” state law claims are impliedly preempted.

Frei, 2020 WL 1165975, at *5 (quoting Buckman).

Because the requirement to provide a Medication Guide to distributors is based solely in the requirements of the FDCA and related regulations, and there is no parallel duty to provide a Medication Guide under [state] law, Plaintiffs claims based upon failure to provide a Medication Guide are preempted under Buckman.  Stated another way, Plaintiffs’ claims against [defendant] for failure to provide a Medication Guide are preempted and due to be dismissed because the claims would not exist in the absence of the FDCA.

McLeod, 2017 WL 1196801, at *9 (citation omitted).

[Defendant’s] obligation to provide a medication guide arises solely from responsibility imposed by the FDCA. . . .  Since [plaintiff’s] claim concerning receipt of the medication guide exists exclusively due to the federal regulatory scheme, her claim must fail as the cause of action is merely based upon alleged violation of the FDCA.

Moore, 277 F. Supp.3d at 881 (citations omitted).  We’d already learned always to use Buckman, but amiodarone cases are good reinforcement of that lesson.

Frei tried to avoid preemption by claiming the same purported failures to provide medication guides as negligence per se.  Didn’t work.  Negligence per se based on FDCA requirements was Buckman preempted, since the FDCA “is not privately enforceable.”  2020 WL 1165975, at *6.  Plaintiff also asserted the same claims under New York’s “little FDCA” statute.  That gambit also failed:

In one breath, plaintiffs argue “they did not plead that any of the FDA warning[s] were inadequate,” yet in a second [they] argue [defendant] committed negligence per se by “misbranding” its product.  Moreover, and again, the FDA approved the labeling and warning information associated with [the drug], and [defendant], a generic pharmaceutical manufacturer, has on ongoing duty to provide the same warning labels.

Id. at *7 (citation omitted).  This is a reprise of lesson one – Mensing preempts all warning claims, no matter how  plaintiffs try to disguise them.

Medication guide claims in amiodarone cases also fail because they directly implicate the learned intermediary rule – that prescription medical product manufacturers are legally required to provide labels to prescribers in the medical community, and those prescribers, not manufacturers, in turn provide warnings to their patients.  Stevens, 70 F. Supp.3d at 1254 (“failure to allege [the] prescribing physician was not adequately informed about the risks . . . is fatal to plaintiffs’ claims”).  The Fourth Circuit affirmed dismissal of medication guide claims in Bean on this basis (not reaching preemption):

In this case, [the prescriber] is the learned intermediary.  As [plaintiff’s] physician he was best placed to evaluate [his] medical history and circumstances and to decide what information [plaintiff] needed to give informed consent to his treatment.  Accordingly, as long as the [the prescriber] himself. . . .

765 F. Appx. at 936 (quoting Restatement (Third) §6).  But because of Mensing, “It is uncontested that [the prescriber] received all the warnings required by federal law, and that these warnings are, on their own, adequate under state law.”  Id.  Thus,

The manufacturers made [the prescriber] aware of the risk . . . as they were required to do by federal law.  That warning was never contradicted or diluted:  There is no allegation that the manufacturers ever so much as insinuated that this risk was less severe that it really was.  The only allegation is that the manufacturers misled [the prescriber] on an unrelated issue − the benefits of [the drug] − which does not come under the scope of failure to warn liability.

Id. at 937.  Nor did the FDA’s medication guide requirement create any “exception” to the learned intermediary rule.  Id. (“Such an exception would fly in the face of the FDA’s intent that the Medication Guide rule not ‘alter the duty, or set the standard of care for manufacturers.’”) (quoting 63 Fed. Reg. 66378, 66384 (FDA Dec. 1, 1998)).

Other amiodarone decisions agree.  “[P]hysicians may and often do prescribe drugs for unapproved, off-label uses, as [plaintiff’s] physician allegedly did here.  The decision to prescribe [a drug] for an off-label use rested solely with his physician.  Within the context of prescription drugs, … [this jurisdiction] employs the learned intermediary doctrine.”  Connolly, 2014 WL 12480025, at *5.  Same result, slightly different take:

The application of the learned intermediary doctrine to Plaintiffs’ “off-label” promotion claims exposes a conceptual flaw in Plaintiffs’ case.  To avoid preemption . . ., Plaintiffs state they do not challenge the adequacy or content of the FDA approved warnings for amiodarone. . . .  Yet, in order to overcome the learned intermediary doctrine in this case, [the] prescribing physicians would essentially have to testify that they were unaware of a risk that Plaintiffs allege was adequately disclosed in the Medication Guide for amiodarone.  Critically, Plaintiffs have not alleged that the prescribing physicians did not receive the Medication Guide or were otherwise unaware of its contents.

McLeod, 2017 WL 1196801, at *10.  See McLeod II, 2018 WL 1456739, at *3 (learned intermediary rule barred claim where plaintiffs did not allege either lack of prescriber knowledge or anything else that would have “changed their decision to prescribe”).  Lesson six is that, even when a defendant has a good preemption defense, do not ignore alternative state-law grounds.

Second, a medication guide doesn’t make any difference where a plaintiff is simultaneously alleging an off-label use.  Off-label uses aren’t allowed in FDA-mandated medication guides to start with:

The plaintiffs fail to assert how the lack of a Medication Guide has any bearing on a claim of failure to warn for medication prescribed for an off-label use.  [The complaint] suggests that the plaintiffs concede the “content” of the relevant warnings were sufficient, and they seek to recover solely for the failure of decedent to receive the Medication Guide.

Stephens, 70 F. Supp.3d at 1249.  “[T]he court is struck by the inherent contradiction in plaintiffs’ allegations, specifically that they were not provided warnings for a use of [the drug] that was not within those warnings.”  Id. at 1251.  Doctors, not manufacturers, are responsible for off-label uses:

The plaintiffs fail to allege that but for defendants’ misrepresentations or suppressions about amiodarone, [decedent’s] doctor would not have prescribed this medication.  Similarly, while plaintiffs allege [the decedent was not aware that his use of the medication was for an “off-label” use, the relevant inquiry is whether his physician was aware of this.

Id. at 1252 (citation and quotation marks omitted).  Moore recognized the same problems in dismissing an express warranty case – a defendant doesn’t “expressly” warrant anything about an off-label use.  “[Plaintiff’s] use of Amiodarone . . . was ‘off-label.’  Despite her alleged reliance, the express-warranty claims are without merit because the labels never explicitly warranted that [Amiodarone] was safe for” any off-label use.  277 F. Supp.3d at 887.  Lesson seven is always to point out when a plaintiff’s claim just doesn’t make any sense.

We also spotted a couple of one-off arguments in amiodarone cases.  In Frei the plaintiff pushed a consumer fraud claim under a New York statute.  Consumer fraud has never been a good fit with the learned intermediary rule, and wasn’t in Frei:

[B]ecause a drug manufacturer’s duty to warn of a drug’s side effects runs to the doctor prescribing the drug, and not to the user of the drug, the issuance of [prescription] drug warnings . . . is not an act directed at consumers, and therefore any alleged deceptive act related to the issuance of those warnings is not a ‘consumer oriented’ act actionable under [the statute]. . . .  To state a plausible . . . claim, a plaintiff must allege that the act, practice or advertisement was consumer-oriented and misleading in a material respect, and that plaintiff was injured as a result of such conduct.

2020 WL 1165975, at *7.  That’s a repeat of an earlier lesson – pursue all state-law defenses.

Finally, one plaintiff tried to get around the problems with medication guide claims by claiming that the defendant was, in fact, a “distributor” rather than a manufacturer.  Preemption barred that claim, as well, because mere distributors have no power to alter FDA-approved labels.

Outside of the context of fraudulent joinder and removal/remand, courts have extended Mensing to entities that merely distribute prescription drugs, be they generic prescription or brand-name prescription drugs.  These cases recognize that mere distributors lack the ability to make any changes to an FDA approved label, rather only the holder of a New Drug Application (NDA) or the FDA itself can make any change to an FDA approved prescription drug label.  In this respect, a mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label.

Marroquin, 367 F. Supp.3d at 1170 (citations omitted).  That’s the last good lesson, and one that applies broadly to all prescription drug warning claims.  All distributors now have a preemption defense under Mensing/Bartlett.

We’ve posted more times than we can count in support of the position that FDA-regulated manufacturers should be able to engage in truthful “promotion” of the off-label uses of their products.  Well, on nationwide TV – and in the presence of the Commissioner of the FDA – on March 19, 2010 the President of the United States promoted the off-label use of a prescription drug, hydroxychloroquine sulfate (branded name:  Plaquenil), for treatment of COVID-19.  See Video at 12:18-14:56.  We won’t go so far as to call the promotion “truthful,” because we frankly don’t know, and the President has made numerous other statements in press conferences that have later been clarified, qualified, walked back, or otherwise changed soon afterward by his officials.

Indeed, FDA did clarify that any implication that hydroxychloroquine was approved for COVID-19 was false, although it promised to keep reviewing this, and other drugs as possible COVID-19 treatments.  Elsewhere, health experts have widely stated that, despite some interesting in vitro results, there is no evidence that this drug (which has significant risks, including life-threatening cardiovascular disorders) makes a clinically significant difference as an anti-viral in either animals or humans.

Hydroxychloroquine has been around a long time, and is now almost entirely generic, but its FDA-approved labeling has only one intended use:

INDICATIONS AND USAGE

Malaria

PLAQUENIL is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax.

PLAQUENIL is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.

FDA labeling at second-third unnumbered page.

The FDA does not regulate the therapeutic use of approved drugs (and medical devices) for conditions other than those for which such drugs are labeled.  “[O]ff-label use is generally accepted” under the law as a “necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350 (2001).  Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.”  Id. at 351 & n.5. Indeed, elsewhere in the same press release, FDA also stated:

Disseminating information about promising off-label uses of drugs we already have, investigating their effectiveness, and pursuing other therapeutics will help give American healthcare providers the tools they need to save lives.

We do agree with the President, a rare event, that FDA’s current restrictions on truthful off-label promotion are “outdated rules” (video at 9:16-:18) and create “unnecessary” barriers (video at 9:29-:32) to communication of medical information.

Another drug, remdesivir, was also mentioned (video at 14:46-15:50) as supposedly “essentially approved.”  That certainly wasn’t true, as the FDA commissioner later cleared up (video at 23:43-24:20).  Unlike an approved drug, remdesivir could be distributed to members of public only through means like FDA’s “compassionate use” program.

The COVID-19 crisis has thus brought into sharp relief the ongoing tension between communications about potentially meaningful off-label uses of approved drugs and the limits the FDA places on what truthful statements a manufacturer can make about its own approved drug.  Those who manufacture hydroxychloroquine would not have been allowed to say what the President or even the FDA have stated about this potential off-label use of their product.

Today’s guest post is by Tucker EllisDick Dean, a longtime friend of the blog and our most prolific non-Reed Smith guest blogger.  This post is a follow-on to the Blog’s discussions of purposes and objectives preemption in light of increasing skepticism about this aspect of preemption by some members of the Supreme Court.  As always, our guest posters are 100% responsible for their writings, entitled to all the credit and any blame.

**********

To paraphrase Bexis, I would not have even read the Supreme Court’s recent decision in Kansas v. Garcia, ____S.Ct.____, 2020 WL 1016170 (U.S. March 3, 2020), but for the fact that it tripped my automatic searches for cases citing Buckman Co. v. Plaintiffs’ Legal Comm., 475 U.S. 282 (1986), and implied preemption.  See opening paragraph of “Will Agency Deference Ruling Affect Preemption” July 15, 2019.  And I was drafting this post about Garcia when Bexis struck again on March 12, pointing out the concurrences by Justices Thomas and Gorsuch noting their skepticism of purposes-and-objectives preemption and urging use of “logical contradiction” analysis in addition to the traditional purposes-and-objectives preemption argument.  See Nov. 4, 2019 post.  That is both true and important, but I was headed in another direction.

Interestingly, the four Mensing dissenters (Ginsburg, Breyer, Sotomayor and Kagan) were also in dissent in Garcia, but they all supported a finding of purposes-and-objectives preemption.  (So that is four Justices who believe in the concept of purposes-and-objectives preemption; and we know that Chief Justice Roberts and Justice Alito also believe in it from their dissent in Wyeth v. Levine, 555 U.S. 555 (2009).  Seeing how the Garcia dissenters got there makes the case informative to those of us in the pharma space.  It presents an aggressive purposes and objectives argument.

Garcia affirmed a criminal conviction on state-law identity theft charges in an immigration context.  Garcia is a follow-up case to Arizona v. United States, 567 U.S. 387 (2012), where the court relied on obstacle preemption to bar states from making criminal what the federal government had failed to make criminal with regard to alien employment verification.  The question presented in Garcia was whether states could use state statutes not directly addressing alien employment verification to prosecute conduct within that area—or, more precisely, not use because of preemption.

In Garcia, three aliens were charged with a violation of Kansas’s identity theft statutes by falsely using the identity of other persons when they completed I-9 forms (federal proof of legal status to obtain employment) and related W-4s (federal withholding forms) and K-4s (state withholding forms), both of which contain social security information.  Those convictions seem straightforward on their face (false social security information was used to verify employment eligibility), but the Kansas Supreme Court reversed, holding that 8 U.S.C. §1324 a(b)(5) prohibits a state from using “any information contained within [an] I-9 as the basis for a state law identity theft prosecution of an alien who uses another’s Social Security information within an I-9.”  The U.S. Supreme Court reversed and upheld the convictions.  All nine justices found that there was no express preemption (those arguments were incredibly technical, and a tour through the dictionary, and are not discussed here).  But the Garcia Court split sharply on the implied preemption issue.

The majority rejected conflict preemption, noting that the fact Kansas’s laws “overlap to some degree with federal criminal provisions does not even begin to make a case for conflict preemption.”  And in their concurrence, Justices Thomas and Gorsuch noted their dubious views of purposes-and-objectives preemption.  The dissent, written by Justice Breyer, first found that federal immigration laws showed “that Congress has occupied at least the narrow field of policing fraud committed to demonstrate federal work authorization.”  2020 WL 101617020, at *13 (citing Arizona, 567 U.S. at 400).  We know that field preemption decisions are few and far between.  But the dissent did not stop there.

There is much obstacle preemption language and analysis here.  The decision was premised on the obstacle preemption holding in Arizona.  If the states could not make criminal what the federal government had failed to criminalize with respect to alien employment verification, then similarly, the dissenters concluded that criminal enforcement in this area therefore fell to the federal government alone.  By contrast, the dissenters noted that the false social security numbers could have been used by the state in a prosecution for other crimes, for example, hiding a criminal history or paying less in taxes than lawfully owed.  The dissenters cited Buckman for the proposition that even “facially neutral state laws [like identity theft statutes] may be preempted when applied in a particular factual context in particular way.”  In summary, the dissent saw a clear Congressional purpose and that state prosecutions were outside that purpose.  As I was reading this, I was reminded of Justice Breyer’s majority opinion in Geier v. American Honda Motors Co., 529 U.S. 861 (2000), the high-water mark of purposes-and-objectives preemption.

To be sure there are different judicial perspectives on preemption depending on the underlying subject matter, e.g.., tort liability versus immigration enforcement.  Mensing was an impossibility preemption case; Arizona and Garcia were obstacle preemption cases.  But the dissent here is worth a careful read and possible use as we frame our arguments down the road in the pharma space when we advance an obstacle preemption argument.  It shows an aggressive use of a purposes argument to find preemption of an otherwise neutral statute.  Those arguments are not that common in our space.  But they exist. Zogenix, Inc. v. Patrick, 2014 WL 1454696 (D. Mass. 2014) (holding state cannot prohibit sale and distribution of drug approved by FDA) (case was not appealed since state revised its policies) (discussed here).  That case was decided on traditional purposes-and-objectives grounds but it does offer a good example of how Bexis’ logical contradiction argument could be advanced.  One key to that argument is showing that the federal interest does not “wander far from the statutory text.”  Wyeth v. Levine, 555 U.S. at 583 (Thomas, J., concurring).  But federal statutes are very clear that it is only the federal government, more precisely the FDA, that can decide which drugs may be marketed in this country.  It would indeed be a logical contradiction to permit states to invade that exclusive process.

Now comes the pathos of social distance. As with many of you, we are working remotely. The pantry shelves are groaning under the weight of so many soup cans. Our only reliable encounter with other humans is with the UPS delivery driver, through a door-glass darkly.

Per our Spring Break plans, right now we should be touring the distilleries of Islay, Scotland (their product makes for a delightful disinfectant), but we reluctantly canceled after being scolded that we are in a group especially vulnerable to Covid-19. You see, we dwell in geezerdom, with more sugar than hemoglobin coursing through our ancient veins. Sigh.

Time to cocoon with Netflix – and product liability decisions crowding our inbox.

Defense-hack though we undeniably are, we felt sympathy for the plaintiff in Small v. Welldyne, Inc., 2019 WL 2439143 (4th Cir. June 12, 2019). According to the complaint, an elderly woman in North Carolina ingested prescription medications sent to her by mistake. She had been receiving her prescription medications through the mail. We can relate, and it is usually a pretty good deal. One day she received a package containing six prescription medications that looked like the usual package but wasn’t. The package was addressed to her, it was the same size and color, and the individual bottles seemed to be the same as those she had been getting. But the labels on the individual bottles were addressed to a different customer – one in California – and different meds resided in the bottles.

The North Carolina woman was barely literate, did not read the labels, took the pills, began to experience confusion and hallucinations, fell and fractured her leg, went to hospital, experienced other medical problems, and eventually died. Her son brought a lawsuit on behalf of the estate against the shipper alleging negligence and breach of warranty. The district court granted summary judgment, ruling that the decedent’s contributory negligence precluded any recovery (North Carolina is one of the very few states left that applies the old complete bar contributory negligence rule) and that the connection between the medications and the death was too attenuated.

The plaintiff appealed to the Fourth Circuit. That circuit is not known as possessing a particularly pro-plaintiff, bleeding heart. Nevertheless, it reviewed the arguments de novo, reversed the summary judgment on the negligence claims while affirming on the implied warranty claim, and remanded the lawsuit.

Why?

First, the Fourth Circuit held that the contributory negligence issue was one for the jury. It is not clear from the opinion whether it mattered that the patient was geriatric and barely literate. It is clear that there was a North Carolina case on the books holding that failure to read a warning, in certain circumstances, might not constitute contributory negligence as a matter of law. Plus, there were some ambiguities in the record as to the extent to which the woman’s relatives had or had not counseled her against taking the medications.

Bottom line: if you are relying on a warning in a North Carolina case to set up a contributory negligence defense, pay close attention to the case law and the specific facts in your case.

Second, the Fourth Circuit held that the competing expert testimony as to medical causation was an issue for the jury, not summary judgment. The plaintiff experts set forth a chain reaction theory: the wrong meds caused the woman’s blood pressure to drop, which resulted in confusion, which led to a fall, which led to hospitalization, etc. The district court thought that was an “etc.” too far. It was a failure of proximate causation as much as medical causation. The Fourth Circuit again reversed, opining that the expert opinions, on their face, could have supported a verdict for the plaintiff.

But that conclusion assumed that the plaintiff expert opinions were admissible. The court below had not considered the defendant’s arguments that those opinions flunked the Daubert standards. Thus, the Fourth Circuit remanded the case with instructions to conduct a Daubert analysis on the plaintiff expert medical causation opinions.

We’ll await further developments. We’d hate to think we’ll still be hunkered down at home when the district court does Daubert. In truth, cabin-fever is a small price to pay to avoid spread of a much more serious fever. Safety must come first, and we hope you all remain safe and well.

We haven’t had a word to say on the Blog about the biggest health story in the world.  That was because, until now, there wasn’t a product liability angle to it.  That’s now changed.  On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published in the Federal Register a “notice of declaration” conferring broad-based immunity from tort (including product liability) litigation for those engaging in “activities related to medical countermeasures against COVID-19.  This declaration is now published at 85 Fed. Reg. 15198 (HHS March 17, 2020)

HHS is conferring tort immunity pursuant to 42 U.S.C. §247d-6d (the Public Readiness & Emergency Preparedness Act) and 21 U.S.C. §§564A-B (the Pandemic and All-Hazards Preparedness Reauthorization Act), and the immunity grant will be accompanied by a “compensation program.”  85 Fed. Reg. at 15198.  The immunity extends to “any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures.”  Id. (emphasis added).  The immunity extends not only to COVID-19-fighting drugs, but also to “products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic.”  Id.  The only exception is for “willful misconduct.”  Id.

The immunity being conferred shoves other federal laws aside as well as preempting state law.

[A] covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.

85 Fed. Reg. at 15199.

The “covered persons” – those entitled to claim immunity – includes “manufacturers” and “distributors,” which are defined as:

A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

A distributor means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to:  manufacturers; re-packers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

Id.  The immunity extends to other defined entities, “program planners, and qualified persons, and their officials, agents, and employees, and the United States,” falling outside of traditional product liability defendants.  Id.  We’re not addressing that aspect of the immunity declaration.

The “covered countermeasures” – what the immunity applies to – are  “qualified pandemic or epidemic product[s],” “security countermeasure[s],” and “a drug, biological product or device authorized for emergency use.”  Id.  These countermeasures are also defined:

A “qualified pandemic or epidemic product means a drug or device . . . or a biological product . . ., that is

  • manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause;

  • manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device;

  • or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.

85 Fed. Reg. at 15199.  One “example” is “liability claims alleging negligence by a manufacturer in creating a vaccine.”  Id. at 12.

A “security countermeasure” is:

a drug or device . . . or a biological product . . . that (i)(a) The Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat . . ., or (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and (ii) is determined . . . to be a necessary countermeasure to protect public health.

Id.  These “countermeasures” must be FDA “approved or cleared,” “investigational” under the FDCA or else “licensed” or “authorized for emergency use.”  Id.  They include “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19” and “any device used in the administration of any such product, and all components and constituent materials of any such product.”  Id. at 15202.

The universe of immunized claims extends to those brought by anyone “who should be vaccinated or take a drug or other countermeasure” or “who uses or who is administered a Covered Countermeasure.”  Id. at 15200, 15202.  Beyond that, “liability immunity is afforded . . . [t]o manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population.”  Id. at 15200.  Further, “liability immunity is afforded . . . to manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in [any particular] geographic areas.”  Id. at 15201, 15202.

For now (extension is possible), immunity “extends . . . through October 1, 2024 – over 4½ years, and even longer if any given product is “obtained for the Strategic National Stockpile.”  Id. at 15201, 15202.  Immunity from liability extends to claims by persons not eligible for the corresponding compensation program.  Id. at 15201 (“requirements for compensation . . . may not align with the requirements for liability immunity”), 15202 (“immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population”).

The HHS declaration is couched in a lot of administrative word salad, but we think that the prime takeaway is that the scope of tort immunity being conferred by the HHS declaration is quite broad.  It is also very important, since our clients have already been authorized to cut regulatory corners to develop new products and are being asked to do all of this, possibly (it’s hard to tell from one day to the next) at cost or close to it.

The clear import of the declaration is to clear the way for science-based organizations and public health professionals to take control of the situation immunized from legal second-guessing.  We hope this declaration is an indicator of a new direction for the federal government’s, and the country’s, response to COVID-19.

We are just going to dive right into it today.  Because in a world where the rules and the situation are in such a state of flux and unknown, a little taste of something familiar is reassuring.  Such as – no causation, no case.  That’s tried and true.  Music to our ears every time.  So, if you are feeling a little overwhelmed or just a little lost, here’s a little bit of normal.

Plaintiff brought design defect and failure to warn claims against the manufacturer of a robotic device used to assist doctors in laparoscopic surgeries.  Pierre v. Intuitive Surgical, Inc., 2020 U.S. Dist. LEXIS 41474 (S.F. Fla. Mar. 6, 2020).  While undergoing a hysterectomy, she sustained a thermal burn to her bowel.  Id. at *1.  Plaintiff alleged that the device was prone to microcracks that allowed electrosurgical energy to leak to tissue and potentially cause thermal injury, a risk known as arcing.  Id. at *4.

The court began its analysis with plaintiff’s design defect claim.  The first thing to explain is that in Florida, the definition of design defect “is in a state of flux.”  Id. at *13.  While most courts use one of the three design defect tests – consumer expectations, risk utility, or reasonable alternative design – Florida hasn’t picked one yet.  So the court used all three.

On consumer expectations, defendant rightly argued that it should not apply to a complex device such as a robotic surgical device.  The court didn’t find the argument meritless.  After all, medical devices are intended for use by physicians and trained medical professionals, not the ordinary consumer.  Id. at *15-16.  However, the court was more persuaded by the Florida Supreme Court’s general philosophy that the burden should be on the manufacturer, not the injured consumer and therefore, consumer expectations had to come into play.  Id. at *16.   In this case, however, plaintiff failed to establish that the device did not perform to her or her surgeon’s expectations because there was no admissible evidence that the risk, arcing, actually occurred during plaintiff’s surgery.  Plaintiff’s surgeon didn’t notice it, he only assumed it occurred because of the inadmissible hearsay of another physician who watched the recording of the surgery.  So, applying consumer expectations, there was no design defect.  Id.

On risk-utility, plaintiff relied on adverse event reports showing microcracks and that was sufficient to raise a question of fact on whether there was an unreasonable risk associated with the design of the product.  Id. at *18.   So too on alternative design plaintiff was able to present evidence of a safety feature utilized on other products that she alleges should have been used on defendant’s product, id. at *20, despite it not being industry-required.  See id. at *4.  But, while plaintiff may have raised a factual issue for trial as to whether the device was defectively designed, her claims failed for lack of causation.

Plaintiff’s only causation expert was her surgeon.  Because he was not a retained expert, he was not required to submit an expert report – so long as his opinions were formed during and because of his treatment of plaintiff.  Id. at *25.  “However, if a treating physician’s opinion is based on information outside of his or her personal observations, the treating physician’s opinion is inadmissible unless the physician provides a written report in compliance with Rule 26(a)(20(B).”  Id.   Plaintiff’s surgeon’s testimony regarding what he observed directly contradicted his litigation-driven causation opinion.  He did not see any defect in the instrument or witness arcing during the surgery and the injury was more likely related to other pieces of equipment in use at the time.  Id. at *26.  Because his causation opinion was not made based on his personal observations during treatment, it was inadmissible without a written report.  Id. at *26-27.

Plaintiff’s surgeon’s causation opinion was also based on hearsay statements made by a colleague.  He asked the other doctor to review the videotape of the surgery and according to plaintiff’s surgeon, that doctor concluded the injury was due to arcing.  However, the other doctor is now-deceased.  The court found no hearsay exception applied and therefore, plaintiff’s surgeon could not base his opinion on inadmissible hearsay.  Id. at *27-29.  And, as if that wasn’t enough, plaintiff was using her surgeon’s testimony and other circumstantial evidence to attempt to prove causation via differential diagnosis.  Differential diagnosis alone is insufficient to prove causation.  Id. at *29.  Without causation evidence, plaintiff’s design defect claims failed – both strict liability and negligence.

Plaintiff’s failure to warn claim didn’t fare any better.  First, plaintiff had no expert testimony regarding the adequacy of the warnings and with a complex medical device that is a requirement.  Id. at *33-34.  Second, the device’s instructions for use contained warnings about the risk in question.  Id. at *34.  But, even if the court hadn’t concluded that the warnings were adequate as a matter of law, plaintiff’s failure to warn claim also failed for lack of causation.  To establish causation, plaintiff had to show that her surgeon would not have used the device if adequate warnings had been provided.  Id. at *36.  Here, the testimony was that her surgeon not only knew of this exact risk but also warned plaintiff of the risk via a signed informed consent form.  Id. at *37.  Again, no causation, no claim.

Complete summary judgment for this defendant.  Completely satisfying for defendants everywhere.

Like most of you, and like our co-bloggers (from whom you will hear similar laments this week) we are in the midst of “social distancing.” We have locked down our home, begun an indefinite period of working remotely, ordered a case of boxed macaroni and cheese, and fielded emails cancelling an inordinate number of long-awaited events.   The final straw was the not-unexpected cancellation of the Philadelphia stop on Jane Goodall’s lecture tour.  The tour, entitled “Gombe: 60 Years of Discovery” commemorates Dr. Goodall’s 60 years of studying wild chimpanzees at her Gombe Stream Research Center in Tanzania. We have revered Dr. Goodall for many of those years. As an untrained 23-year-old secretary, Jane Goodall telephoned Dr. Louis Leakey and told him she wanted to study great apes. And the rest truly is history.  We are – and always have been – in awe.  (At one point, we could recite the family trees of the key groups of Gombe chimpanzees.)  It would be an understatement to say that we were overjoyed to have tickets to see Dr. Goodall in person for the first time.  And now, like everything else, it is cancelled.

This too shall pass, and such disappointments obviously must take a back seat to much larger global health concerns. We look forward to speaking of all of this in the past tense.  In the meantime, we will look for glimmers of positivity, in life and in jurisprudence.  Today’s case is such a glimmer.

Regular readers will recall that our last post bemoaned a dismal warnings causation decision out of the Eastern District of Pennsylvania.   Lest you conclude that no one ever gets this right, we give you In re Taxotere (Docetaxel) Prods. Liab. Litig. (Kelly Gahan), 2020 WL 1830851 (E.D. La. March 3, 2020), a case out of the Taxotere MDL.   The plaintiff, an emergency room physician, took the defendants’ cancer medication when she was diagnosed with breast cancer.   She asserted the usual product liability claims, including failure to warn, alleging that the drug caused permanent alopecia (hair loss).

The defendants moved for summary judgment (Colorado law applied to the plaintiff’s substantive claims) arguing that, under the learned intermediary doctrine, the plaintiff could not meet her burden of proving that any inadequacy of the defendants’ warnings proximately caused her alleged injuries, because her prescribing physician would not have changed her decision to prescribe the drug even if the warning had been different.

In response, the plaintiff argued that the learned intermediary doctrine did not apply in the absence of a finding that the label adequately warned of the adverse event she suffered, and that the drug’s label did not warn of permanent alopecia (thought the doctor had independent knowledge of this risk).  As we recently have found ourselves arguing over and over, this is backwards. The learned intermediary doctrine informs the entire failure-to-warn analysis by providing that a prescription drug manufacturer has a duty to provide adequate warnings only to the prescribing physician and has no duty to warn the patient directly. Application of the doctrine does not turn on a finding that the warnings were adequate.  That comes next.

The Gahan court agreed, emphasizing that it was the plaintiff’s burden to prove the causation element of her warnings claims; in other words, that “an adequate warning would have changed her doctor’s prescribing decision.” 2020 WL 1830851 at *2.  In this case, the evidence showed that three of the patients to whom the doctor had previously prescribed the drug suffered permanent hair loss, and that the doctor had read numerous relevant articles, including one that described the risk of permanent alopecia associated with the drug.  The doctor shared all of this information with the plaintiff, discussed all of the pros and cons of the drug, provided the plaintiff with an alternate chemotherapy option, and ultimately left the choice up to the plaintiff. The doctor “made her prescribing decision only after several robust discussions with [the plaintiff] about her two options.” Id. at *3. “It was [the plaintiff] who made the ultimate decision” to proceed with the defendants’ drug “after conducting her own research.” Id.  Crucially, the doctor testified in her deposition that there was no label change would have changed her prescribing decision.

The court found that it could not “escape the undeniable conclusion that [the doctor] was aware of the risk of permanent hair loss and proceeded” with the drug regimen anyway.   As such, the court held, the plaintiff had “failed to create an issue of fact on whether [the doctor’s] prescribing decision would have changed if [the defendants] had adequately warned of the alleged risk” of permanent hair loss. Id. a *4. Summary judgment for the defendants on the warnings claims.

We love this decision.   It correctly articulates the applicable burden of proof then follows through to dismiss the claim when the plaintiff cannot satisfy her burden.  Trust us — this doesn’t happen very often. We will continue to bring you best and the worst decisions on this issue.  Meanwhile, stay safe out there.  We are grateful that we can stay in touch during this time of isolation.

The recent spate of gadolinium cases brought by patients with normal kidney function are looking like fertile ground for federal preemption, and we are not saying that just because we like the results.  Our point is that if you had to come up with an example of a case where federal law ought to preempt state-law product liability claims of all kinds—including both design defect claims and failure-to-warn claims—you might come up with a case like Thomas v. Bracco Diagnostics, Inc., No. 3:19-cv-00493, 2020 WL 1016273 (W.D. La. Feb. 27, 2020).  A magistrate judge in Thomas has recommended dismissal of all claims against a gadolinium contrast agent manufacturer on the basis of preemption, and the order is a good example of how preemption under Bartlett and Albrecht should work.

The plaintiff in Thomas allegedly experienced difficulties after being injected with the defendant’s contrast agent, presumably to create sharper images during an MRI.  Id. at *1.  The problem for the plaintiff though was that his amended complaint (like the complaint before it) ran headlong into federal requirements.  His beef was that gadolinium allegedly had toxic effects when retained in the body, which could have been prevented had the manufacturer (1) designed the product using a compound less likely to be retained and/or (2) provided a stronger warning regarding gadolinium retention.

So let’s take the design defect claim first.  When federal law prohibits a drug manufacturer from changing the chemical composition of a drug without FDA approval, federal law preempts a lawsuit alleging that state law requires such a change.  That’s Mutual Pharmaceutical Co. v. Bartlett, the 2013 Supreme Court case holding that design defect claims against a generic manufacturer were preempted because the manufacturer had no ability under federal law to change the design of its products.  We were quick to observe at the time that Bartlett’s rationale applied equally to innovator drugs, and multiple courts have since agreed.  The most notable opinion of this kind is probably Yates v. Ortho-McNeil-Janssen, 808 F.3d 281 (6th Cir. 2015), which we discussed here.

The facts of Thomas fall squarely in the Bartlett bucket.  The plaintiff’s proposed alternate design using a different compound was a “change to the qualitative formula and thus a major change” requiring FDA pre-approval.  As a result, because the defendant manufacturer could not have independently adopted the proposed alternative, any state requirement purporting to compel that alternative was preempted.  Thomas, at *9.

The failure-to-warn claim met a similar fate, but under different Supreme Court authority—Wyeth v. Levine and Merck v. Albrecht.  Implied preemption of a failure-to-warn claim can be a tough row to hoe for innovator drugs (as opposed to generics), owing mainly to the “clear evidence” standard first announced in Levine.  As the standard goes, a failure-to-warn claim is preempted if there is clear evidence that the FDA would not have approved the warning that the plaintiff alleges is required under state tort law.  Thomas, at *9.

Two factors led to preemption of the failure-to-warn claim in Thomas.  First, as faithful readers of the blog know, Wyeth v. Levine relied heavily on the purported ability of innovator drug manufacturers to unilaterally change their drug labels through the FDA’s Changes Being Effected regulations.  The CBE regulations were no help, however, to the plaintiff in Thomas because the plaintiff presented no newly acquired information regarding the product’s risks.  As the court explained, “Notably, the studies and reports included in Thomas’s complaint discuss how gadolinium can be retained, but do not demonstrate proof of any adverse effects from gadolinium retention.”  Id. at *10.  In other words, because there was no newly acquired risk information, the federal CBE regulations would not permit the label change that the plaintiff’s state-law tort claims would compel.  That’s implied preemption.

But even more importantly, the manufacturer produced clear evidence that the FDA would not have approved a warning about the purported adverse health consequences of injection with the manufacturer’s product.  One month before the plaintiff’s injection, the FDA approved a revised warning specifically about gadolinium retention, which said that retention occurred but that no causal relationship between retained gadolinium and any adverse effect in patients with normal renal function had been established.  Id.  The FDA therefore considered the exact risk about which the plaintiff was complaining and approved warning language that contradicted the plaintiff’s state-law claim.  The court concluded that “[t]he language of the label change, issued very shortly before the Plaintiff’s injection . . ., and specifically stating facts contrary to the warning sought by the Plaintiff, is clear evidence that the FDA would not have approved a label change which warned of such adverse events.”  Id.  That’s implied preemption, too.  Moreover, the defendant met the “clear evidence” standard, even though the defendant did not itself request the label change.

The court dismissed the plaintiff’s claims (brought, by the way, under the Louisiana Product Liability Act) for other reasons, but the main show is preemption.  The facts lined up to meet all the applicable legal standards.  A perfect storm maybe.  Or maybe just a fair result.  We like the latter.