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What happens when you have a class action where some putative class members suffered an injury while others did not? Can such a proposed class even be certified? The answer depends on whom you ask. The plaintiffs/class representatives will surely point out that whether any individual class member actually suffered a compensable injury is a mere administrative detail that can be sorted out after the fact. Trust us, Judge. Just certify the class, and we’ll make sure the right people get paid.

The defendants on the other hand will emphasize (correctly) that there is this little thing called due process, which prohibits certifying a class where individual class members have contested injuries or no injuries at all. That was the dilemma that the First Circuit addressed in In re Asacol Antitrust Litig., No. 18-1065, 2018 WL 4958856 (1st. Cir. Oct. 15, 2018), and the court came to the correct conclusion that a class that includes uninjured class members cannot be certified. The First Circuit also poured buckets of cold water on questionable concepts of aggregated proof and statistical modeling.

Here is what happened. The plaintiffs sued the defendant claiming that its discontinuation of one drug and introduction of similar substitute drugs violated the consumer protection and antitrust laws of twenty-six jurisdictions. Id. at *1. The district court later certified a class of “all Asacol purchasers who subsequently purchased [the alleged substitute drugs] in one of those twenty-six jurisdictions.” Id.

But here is the rub. In certifying the class, the district court found that approximately 10 percent of the class members (mostly if not entirely third-party payers) had not suffered any injury attributable to the defendants’ alleged wrongful conduct. Id. And here is the further rub. The defendants claimed that uninjured class members actually made up more than 10 percent of the class, and the plaintiffs claimed that the number actually was less. In other words, it was undisputed that some portion of the class had no compensable injury, and the fact of injury was contested for some additional and unknown portion of the class.

The district court determined nonetheless that the uninjured class members could be removed “in a proceeding conducted by a claims administrator.” Id. When someone suggests relying on a post-certification “claims process” to smooth over disputed individual issues in a class action, the red flags start to wave in our heads. The submission of a form to a “claims administrator” is not an adequate substitute for the due process to which defendants are entitled absent an agreement, such as with a class settlement.

Red flags waived in the heads of the First Circuit too, resulting in an opinion reversing class certification. First, there was the issue of standing. The defendants argued that the class representatives had never made purchases within twenty-two of the jurisdictions and thus lacked standing to sue under those states’ laws. Id. at *3. In the First Circuit’s view, the issue was whether the class representatives had the proper incentive to advance claims under all those states’ laws, and it ruled that they did. Id. at **3-5. The only carve out was New York, which uniquely requires proof of deception. Id.

Second, the First Circuit considered Rule 23(c)(3)’s requirement that common issues predominate over individual issues, and this is where this class action failed. It was undisputed that some number above or below ten percent of the certified class suffered no compensable injury. Id. at *6. The district court’s major error was its assumption that it would be possible “to establish a mechanism for distinguishing the injured from the uninjured class members” and that “Class members will be asked to submit a claim form, along with data and documentation that may be deemed necessary for consideration.” Id. at *7.

That process would not be sufficient, in part because “[o]ne can only guess what data and documentation may be deemed necessary, what the formula will be, and how the claims administrator will decide who suffered no injury.” Id. The First Circuit distinguished the situation where class members would establish their claims through “’unrebutted testimony’ contained in affidavits.” Id. (distinguishing In re Nexium Antitrust Litig., 777 F.3d 9 (1st Cir. 2015)). Here, the plaintiffs did not intend to rely on unrebutted testimony to eliminate uninjured class members, and the defendants had expressed their intention to challenge any affidavits that might be gathered. Id. Because such disputed individual issues cannot be resolved under Rule 23, the First Circuit’s “inability to fairly presume that these plaintiffs can rely on unrebutted testimony in affidavits to prove injury-in-fact is fatal to plaintiffs’ motion to certify this case.” Id. at *8.

This is an important holding. The predominance of individual issues should preclude class certification under Rule 23(c) in every instance, and that rule applies with no less force when the predominating individual issue is whether each class member has suffered an injury in fact. It is not sufficient, as the First Circuit held, to certify the class based on vague promises of sorting it out later.

Nor is it acceptable to promise proof of “class-wide impact” through purported expert testimony. According to the plaintiffs, proof of “class-wide impact” would result in some uninjured class members receiving compensation, but it will all “net out” in the end and “should be of no concern” to the defendants. Id. at *9. Such rough justice ignores that when a defendant is not liable to particular individuals because they suffered no injury, the amount of total damages should be reduced. Id. Moreover, when relief depends on determining whether an individual has been injured, the defendant must have an opportunity to challenge each class member’s proof. Id.

Finally, the First Circuit condemned the reliance on statistical analysis at the expense of due process. The following quote is long, but you should read it because it is powerful:

Accepting plaintiffs’ proposed procedure for class litigation would also put us on a slippery slope, at risk of an escalating disregard of the difference between representative civil litigation and statistical observations of tendencies and distributions. Once one accepts plaintiffs’ “no harm, no foul” position there would be no logical reason to prevent a named plaintiff from bringing suit on behalf of a large class of people, forty-nine percent or even ninety-nine percent of whom were not injured, so long as aggregate damages on behalf of “the class” were reduced proportionately. Such a result would fly in the face of the core principle that class actions are the aggregation of individual claims, and do not create a class entity or re-apportion substantive claims.

Id. at *10 (emphasis added). Read that last line again because it re-emphasizes that Rule 23 is a rule of procedure. It does not bestow substantive rights, nor could it alter substantive law—such as laws requiring proof of an injury in fact before someone can sue—without running afoul of the Rules Enabling Act.

The First Circuit here applied the predominance requirement in a way that essentially enforces the requirement of ascertainability—i.e., you can’t certify a class if you can’t ascertain who would be in the class before certification. The First Circuit also walked back from the Neurontin trilogy, which pushed concepts of aggregated proof beyond the breaking point, which we discussed here. Both are welcome developments.

Did you know that October is National Cybersecurity Awareness Month?  Neither did we, until we started poking around the FDA’s recent press release announcing that it intends to update its guidance on medical device cybersecurity within the next few weeks.  We also learned that National Cybersecurity Awareness Month has been observed each October since its inception in 2004.  Observed by whom?  We’re not exactly sure.  We picture our IT consultants walking office to office handing out hats and stickers with catchy slogans like “A password is like underwear. Change it!”  Or some lame pun involving the work “phishing.”  If it were up to us, we would default to the simple and classic “Ctrl-alt-delete before you leave your seat.”

All kidding aside, cybersecurity threats have moved in recent years from theoretical to very real, and while there remains no reported instance of anyone hacking into a medical device being used to treat a patient, the potential vulnerability is one to which we need to pay attention.

That includes the FDA.  The FDA has published guidance on cybersecurity with regard to both premarket submissions and post-market submissions.  (You can see our take on the postmarket guidance here)  Based on the FDA’s press release, updates are coming to the premarket guidance, specifically to “highlight the importance of providing customers and users with a ‘cybersecurity bill of materials,’ or in other words, a list of commercial and off-the-shelf software and hardware components of a device that could be vulnerable to attack.”  This jibes with the FDA’s general approach to cybersecurity, which is to undertake a risk-based analysis that identifies vulnerabilities, assesses the potential frequency and severity of the risk, identifies mitigations, and proceeds accordingly.  Such a risk-based analysis should be familiar to anyone who operates in the medical device space, where risks and benefits are weighed on a daily basis.

The other news of the press release is the publication of a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which “describes the types of readiness activities that’ll enable HDOs [healthcare delivery organizations] to be better prepared for a cybersecurity incident involving their medical devices.”  This Playbook was prepared by the MITRE Corporation, a government-sponsored research and development organization.  You can get a copy of the Playbook here, and you can that it is aimed at healthcare providers and critical healthcare infrastructure in which medical devices operate.

The purpose of the Playbook is to help HDOs get ready for cybersecurity threats affecting medical devices that could impact continuity of care and patient safety.  More specifically, the playbooks objectives are to:

  • Provide baseline medical device cybersecurity information that can be incorporated into an HDO’s emergency preparedness and response framework;
  • Outline roles and responsibilities for responders to clarify lines of communication “across HDOs, medical device manufacturers (MDMs), state and local governments, and the federal government”;
  • Describe a standardized approach to response efforts;
  • Serve as a basis for enhanced coordination activities among medical device cybersecurity stakeholders;
  • Inform decision making and the need to escalate response;
  • Identify resources HDOs can leverage as a part of preparedness and response activities; and
  • “Serve as a customizable regional preparedness and response tool for medical device cyber resiliency that could be broadly implemented.”

We put that last one in quotes because we’re not exactly sure what “cyber resiliency” means, but we assume it means the ability to fend off a cybersecurity event or at least mitigate its impact.  Toward that end, the Playbook suggests a four phase approach:  (1) Preparedness; (2) Detection and Analysis; (3) Containment, Eradication, and Recovery; and (4) Post Activity.

“Preparedness” means exactly what it says, with an emphasis on mindfulness of cybersecurity when procuring medical devices and keeping an inventory such that the HDO is always aware of what connected devices it has on hand.  HDOs should engage in “hazard vulnerability analysis” (again, a focus on risk) and plan for communicating and responding during an event.  That includes medical device manufacturers, whom the Playbook places squarely within the communication loop with the HDO and the FDA.

“Detection and Analysis” focuses on identifying when an incident has occurred and assessing its priority on a numerical scare that strangely assigns “Emergency” events to “Category 0.”  Analysis and documentation are important parts of the process, too.

The core of the response falls under “Containment, Eradication, and Recovery,” which appropriately focused on patient safety.  Is the device safe to use?  Is there a reliable way to test the device and confirm it is working correctly?  Are there spare or backup devices?  How quickly can the problem be fixed, and has there been collateral damage to the broader healthcare system?  These are the questions that HDO should be asking.

Finally, the “Post Activity.”  The Playbook recommends attention to lessons learned, including possibly retaining a digital forensics expert and updating the plan.

As we have said before, medical device cybersecurity is here to stay, and the FDA has been busy.  In addition to the Playbook (which is not an FDA document, but still, you get the gist), the FDA has entered into memoranda of understanding to form information sharing analysis organizations (“ISAOs”), which are “groups of experts that gather, analyze and disseminate important information about cyber threats.”  The Agency has participated in cybersecurity exercises and summits, and has engaged discussions with other government agencies, including the Department of Homeland Security.  It has proposed a Center of Excellence for Digital Health, which “would help establish more efficient regulatory paradigms, consider the building of new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices.”  We will keep you posted.

Multidistrict litigation is not special. By making this pithy observation, we do not mean to denigrate what has become the mother of all procedural mechanisms.  What we mean is that multidistrict litigation is, at its core, nothing more than a bunch of venue transfers, bringing multiple cases involving common issues before a single district judge for coordinated pretrial proceedings.  The MDL statute does not grant an MDL judge any extraordinary or special powers.  In fact, the statute purports to augment a district judge’s prerogative in only one way:  An MDL judge “may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions.”  28 U.S.C. § 1407(a).

Not very Earth-shattering stuff, but the point is that whatever exceptional gravitas you might attribute to an MDL comes not from an act of Congress.  It comes from the fact that one judge has all the parties and their attorneys in front of him or her with the power to preside over all their cases at the same time.  That includes deciding which cases will proceed, and which will wait, and how proceedings will be conducted for those chosen to go ahead, maybe a few at a time, or maybe in entire “waves.”

It also includes naming the plaintiffs’ Lead and Liaison Counsel, a function that is uniquely important for the plaintiffs’ side because there are usually many more plaintiffs’ lawyers involved and they are generally being paid based on the results. That requires a leadership structure with defined responsibilities and a common-benefit compensation structure to go along.

But where do Lead and Liaison Counsel’s responsibilities begin and where do they end? According to the Yaz MDL judge, who as far as we can tell is the first judge anywhere to address this particular issue, they begin and end with the court’s order creating those roles and defining those responsibilities.  That was the ruling in Casey v. Denton, No. 3:17-cv-00521, 2018 WL 4205153 (S.D. Ill. Sept. 4, 2018), where the district judge presiding over the Yaz hormonal contraceptive MDL held that the plaintiffs’ Lead and Liaison Counsel owed no general fiduciary duty to plaintiffs in the MDL, other than their own clients.  After the bulk of the cases in the MDL resolved, the MDL judge entered an order placing the unresolved cases on separate litigation tracks, with all the deadlines that you would expect:  Fact sheets, case-specific expert reports etc. Id. at **2-3.

Here is where is got ugly. Many of the non-settling plaintiffs blew the deadlines, resulting in motions to dismiss.  The plaintiffs blew the deadlines to oppose those motions, too.  Presented with violations of court orders and utter indifference from the plaintiffs (and their individual attorneys) toward their own cases, the MDL judge justifiably dismissed their cases. Id. No one appealed or sought reconsideration. Id.

So, what is a plaintiff to do, after rejecting settlement and opting to litigate, only then to blow off the resulting litigation deadlines? Of course, you sue your lawyer.  But not your own lawyer.  You sue the Lead and Liaison Counsel who created this whole mess, right?  That is exactly what these plaintiffs did, claiming that the Lead and Liaison Counsel “breached purported fiduciary duties by failing to address (or failing to delegate) the directives laid out” in the court’s orders. Id. at *2.  The plaintiffs analogized to duties owed by attorneys representing classes of plaintiffs, i.e., that Lead the Liaison Counsel’s duties arose from and were created by the court’s order creating those positions and “bestowing” certain duties. Id. at *3.

That proposition was a nonstarter for this judge. First, the court found no fiduciary duty:

It is well established that a “fiduciary” is a person, having a duty, created by his undertaking, to act primarily for another’s benefit in matters connected with such an undertaking. The Court finds the ending of that statement to be the pinnacle instruction on this entire dispute: One can only act in a fiduciary capacity, and thus have a fiduciary duty, to the extent his actions comport within the boundaries set by the agreement initially creating the relationship.

Id. at *4 (emphasis added).  In this case, the document creating the relationship was Case Management Order No. 2, which created the roles of Lead and Liaison Counsel and “very clearly set[ ] out what responsibilities the Lead and Liaison Counsel . . . owed to plaintiffs.”  Moreover, “it is clear from the text that Order No. 2 only imposed tasks geared towards facilitating general work product that could be used for the common good of all plaintiffs,” such as coordination of document depositories, preparing agendas, and conducting common discovery. Id. As the MDL judge concluded, “It was never the intention or spirit of Order No. 2 to supersede the authority or importance of each plaintiff’s individually-retained counsel when it came to specific matters unique to each case.” Id. at 5.

That is not to say that Lead and Liaison counsel own no duty to MDL plaintiffs.  The court analogized to a trustee, who owes a duty to pursue the “good of all.” Id. at *6.  As Judge Cardozo reminded us all in law school, “A trustee is held to something stricter than the morals of the market place. Not honesty alone, but the punctilio of an honor the most sensitive, is then the standard of behavior . . . .” Meinhard v. Salmon, 164 N.E. 545 (N.Y. 1928) (emphasis added).  Whatever the “punctilio of an honor” encompasses, it does not extend to representing an individual plaintiff when her or her own lawyer fails to do so.

Second, the court decided it would be a bad idea to create the fiduciary duty that the plaintiffs wanted.  After all, who would want to be Lead and/or Liaison Counsel if those roles came saddled with the duty to respond to every deadline and otherwise represent individuals with whom they have no engagement?  We have no qualm with the idea that the plaintiffs’ leadership in an MDL should earn their pay, and we know from our view from the other side of the aisle that they work very hard.  But even we have to admit that the plaintiffs in this case were asking too much.

The lesson here is that Lead and Liaison Counsel’s duties are defined by court order, and not so much by common law principles governing fiduciaries. So be careful in drafting and presenting those proposed orders for the judge’s signature.  They may be used against you.  A little gratuitous advice to plaintiffs’ attorneys, who are very unlikely to read our blog.

We sometimes sit around trading stories about the dumbest lawsuits we have ever seen. Our personal favorite is a class action that the Drug and Device Law Spouse defended years ago seeking damages against a national shipping company because items sent by “Second Day Air” did not always go in an airplane.  The packages arrived as promised, but the plaintiffs were shocked, shocked to learn that items sent from San Francisco to Palo Alto were carried in an ordinary (and Earth-bound) truck.  There is also the one about the guy who sued his dry cleaner for $67 million after the cleaner lost his pants.  It was reported that the cleaner showed up in court and tendered the trousers—cleaned and pressed.  The plaintiff was unimpressed.

Many cite the famous McDonald’s coffee spill case of the 1990s as a dumb and frivolous lawsuit, but at least that plaintiff suffered a serious injury—third degree burns that required skin grafts and an extended hospital stay. It was uncontested that the coffee drinker had standing to sue, regardless of what you think about the ultimate allocation of fault.

We cannot say the same for the plaintiff in a class action that an MDL judge in New Jersey dismissed last year for lack of standing, which the Third Circuit has now affirmed. In In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Liability Litigation, No. 17-2980, 2018 WL 4225028 (3d Cir. Sept. 6, 2018), the plaintiff used the defendants’ talcum powder, which worked exactly as it was supposed to without any ill effect.  She did not allege any defect in the product; she did not allege any injury or disease; she did not allege any increased risk of injury or disease; and did not allege any fear of developing any injury or disease in the future. Id. at *2.  She also allegedly used up the product. Id. In other words, there was no durable good or remaining product that she claimed she could not use.  Whatever she purchased, she used it until it was gone. Id.

What a frivolous lawsuit that no intelligent and scrupulous lawyer ever should have filed, right? Well, not exactly.  The district court’s order dismissing the case and the Third Circuit’s opinion affirming that result are clearly correct.  And, “frivolous” is probably a fair description.  Be that as it may, this class action was not a random misfire conceived in the minds of attorneys who didn’t know any better.  This class action was a deliberate and calculated attempt to test the limits of Article III standing and to stretch even further the wrongly decided opinion on standing in Cottrell v. Alcon Laboratories, the Third Circuit opinion that we ranked as the fourth worst drug and device decision of 2017.  That was the opinion where the Third Circuit held that purchasers of eye drops had standing to sue, even when the product labeling was indisputably accurate and the product worked exactly as expected.  How then did the eye drop purchasers suffer any compensable injury?  The bottle dispensed drops that were too big, allegedly resulting in the users paying more than they should have.  We are being charitable in our description of Cottrell.  In fact, the allegations of injury there were too speculative to support standing, as other another Circuit has found and as we have explained here, here, and here.

But at least the plaintiffs in Cottrell attempted to plead an economic injury.  The plaintiff in the J&J Talcum Powder case wanted to take Cottrell one step further by establishing standing to sue while affirmatively pleading no injury at all.  She and her lawyers lost.  The plaintiff in J&J alleged that she suffered an economic injury because, had she been informed that using baby powder could lead to an increased risk of ovarian cancer, she would not have purchased the powder in the first place. Id. at *2.  In other words, she had buyer’s remorse and sincerely wished she had not purchased the product after she consumed it with no harm or worry. Id. at *1.

Those facts did not allege an economic injury. As the Third Circuit explained, there are generally three ways to plead an economic injury.  A plaintiff can allege an “alternate product theory” by alleging that, but for the defendant’s conduct, he or she would have purchased an alternative, less expensive product.  A plaintiff can also allege a “premium price theory,” under which he or she claims that wrongful advertising of a product as “superior” induced the plaintiff to pay an unfair premium.  Finally, a plaintiff can allege that he or she was deprived of the “benefit of the bargain” and did not get what he or she paid for.

The plaintiff’s allegations missed all of these theories. She did not allege that any cheaper alternative existed, and she did not identify any unlawful “premium” paid for her powder. Id. at *2-*3.  As for the “benefit of the bargain,” she alleged only that she was promised that the baby powder was “safe,” when it allegedly was “unsafe” because of an increased risk of ovarian cancer. Id. at *3.

Let’s keep one thing straight. We do not believe there is any reliable scientific evidence that talcum powder can cause ovarian cancer, and we reported on a California court finding exactly that here.  But even taking the plaintiff’s allegations as true, conclusory allegations of purchasing an “unsafe” product did not establish an economic injury sufficient to support Article III standing.  Distinguishing Cottrell, the Third Circuit held that “a plaintiff must do more than offer conclusory assertions of economic injury in order to establish standing.  She must alleged facts that would permit a factfinder to value the purported injury at something more than zero dollars without resorting to mere conjecture.” Id. at *4.

Having used the product, and having failed to allege any injury or even an increased risk or fear of injury, the plaintiff did not have the facts. So what did she offer instead?  A promise of “models for calculating damages and restitution that are linked to her theory or relief and are based on the evidence in the case.” Id. at *6.  Aha, the experts will take care of it all in “models.”  Forgive us for being skeptical, but also give the Third Circuit credit for insisting that a plaintiff still must allege facts:

[E]ven at the pleading stage, a plaintiff must set forth sufficient factual allegations that, if proven true, would permit a factfinder to determine that she suffered at least some economic injury.  . . .

[Plaintiff] fails to allege even that the Baby Powder provided her with an economic benefit worth one penny less than what she paid. We must, therefore, conclude that she received the benefit of her bargain and has suffered no economic injury.

Id. at *7.  The Third Circuit also ruled that an alleged increased risk to others did not count because the plaintiff’s “references to Baby Powder being unsafe to others are not relevant to determining whether [she] has standing herself.” Id. at *8 (emphasis in original).

The Third Circuit found the plaintiff lacked standing to sue for restitution and injunctive relief for similar reasons: Her restitution claim rested on mere conjecture, and her claim for injunctive relief made no sense because she was not at risk of suffering an economic injury.  We don’t blame the plaintiffs’ lawyers for trying to stretch Cottrell beyond the breaking point, but in the end they did not succeed.  The Third Circuit summed it up this way:  “[Plaintiff’s] wish to be reimbursed for a functional product that she has already consumed without incident does not itself constitute an economic injury within the meaning of Article III.”  Amen.

We understand that we write a lot about federal preemption. You might even be rolling your eyes at yet another post on this most powerful of defenses, but we just can’t help ourselves.  Federal regulation runs deep in the drug and medical device world, and the possibility that federal law might preempt state-law claims is an ever-present possibility.  To be sure, there is no shortage of litigation alleging that drug and device companies have violated state law duties, so we don’t want to overstate matters.  Regardless, federal preemption remains the bright shiny object from which we cannot avert our gaze.

Federal preemption demands our attention also because it is so often misunderstood and/or misapplied. We have said at times that some judges are hostile to preemption, and that might be true for some of the obviously result-oriented opinions that we review.  It is more likely that courts confront the many branches of preemption and the spider web of cases applying preemption in its various flavors, and they just get it wrong.  God only knows that the authorities are not always clear.

This is a long lead-in to a recent case that got preemption wrong on so many levels that we’re not completely sure what to make of it. In Tryan v. Ulthera, Inc., No. 2:17-cv-02036, 2018 U.S. Dist. LEXIS 140111 (E.D. Cal. Aug. 17, 2018), the plaintiffs sued the manufacturer of a medical device that uses ultrasound to tighten skin and reduce wrinkles on the face, neck, and chest.  The FDA cleared the device for marketing through the 510(k) premarket notification process, which is different from the more rigorous premarket approval (or “PMA”) process that some other devices go through.  The plaintiffs’ beef was that the manufacturer represented that the device was “FDA approved” (as opposed to “FDA cleared”) in violation of FDA regulations. Id. at **2-4.

The case seems fairly straightforward. Plaintiffs based their claims on an alleged violation of the Food Drug & Cosmetic Act (“FDCA”) and its regulations.  Moreover, the plaintiffs did not allege any complication with their procedures, or even that the device did not work exactly as it was supposed to.  Instead, they alleged that had they known the device was not FDA approved, and that it was merely FDA cleared, they would have paid less for the therapy or considered alternative treatments. Id. at *4.

Whatever you think of those allegations and the likelihood that any consumer would draw any distinction between “FDA cleared” and “FDA approved,” these plaintiffs were suing because of a violation of the FDCA, which runs directly into implied preemption under Buckman and 28 U.S.C. § 337(a).  Whether the device was FDA “approved,” “cleared,” or whatever, without the FDCA, there would be no FDA action at all. Buckman is the Supreme Court case that held that state-law claims conflicting with the FDCA are impliedly preempted, and Section 337 mandates that only the federal government can enforce the FDCA.  Whenever a purported state-law cause of action includes as a “critical” element some sort of FDCA violation, it runs afoul of § 337(a) and is therefore impliedly preempted under Buckman. Buckman involved a 510(k) device, so device categories do not affect implied preemption.

The manufacturer therefore justifiable moved to dismiss on implied preemption, and in denying the motion, the district court got off on the wrong foot, and it got worse from there. The district court began its discussion with the express preemption clause of the Medical Device Amendments, which expressly preempts any state law requirement which is “different from or in addition to” federal requirements. Id. at *10.  This is a valid legal principle as far as it goes, but it is completely irrelevant to this case:  The defendant did not assert that federal law expressly preempted the plaintiffs’ claims.  The defendant asserted implied preemption, under which federal law preempts state law where the state law conflicts with federal law or stands as an obstacle.

You might ask what difference that would make? Well, it makes a big difference, because in its next breath, the district court invoked the questionable and often-misunderstood “parallel claim” exception to preemption.  As the “exception” goes, because the MDA’s express preemption clause preempts state-law requirements that are “different from or in addition to” federal requirements, claims based on state-law duties that “parallel” federal requirements are not preempted.

We can debate whether the “parallel claim” exception is a good idea or whether federal authorities actually support its existence. One thing, however, is certain:

There is no parallel claim exception to implied preemption.

The district court’s introduction of express preemption at the outset of its opinion was therefore no harmless error. It started the opinion down a legal path from which the opinion would never recover, as the court forced the plaintiffs’ allegations into an “exception” that does not exist.  For example, the district court noted with approval that the plaintiffs alleged that California law “incorporates and mirrors the FDCA.” Id. at *11.  In the context of implied preemption, that observation alone should have been the death knell of this case because it acknowledged in plain terms that the plaintiffs were suing to enforce the FDCA.  We know from Buckman and section 337(a) that such actions are not allowed.  The “mirroring” of California law matters only in food cases, to which a statutory exception to section 337(a) applies.  That exception does not apply to medical devices (or drugs), which we detailed here.

Unfortunately, the district court misapprehended this point again and again. It noted the “linkage” between state and federal law and cited the plaintiffs’ use of federal “regulatory and statutory violations” as the predicates for their state-law claims. Id. The court noted that California statutes adopt federal regulations as state-law standards. Id. The court observed that California law prohibits false and misleading advertising.  And why is it misleading to say a Class II medical device cleared through the premarket notification process is “FDA approved”?  Because such a statement allegedly violates federal regulations.  All paths lead back to the plaintiffs suing to enforce the FDCA, which is the epitome of implied preemption.

The district court also wrongly cited federal law in support of its opinion. It relied on Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), to describe the FDA’s 510(k) process. Id. at **5-6.  The court certainly is not alone in citing Lohr on this point, but as we have explained here and here, Lohr understates and marginalizes the 510(k) process’ focus on safety and efficacy and was outdated even before it was published.  The district court also stated that “FDCA regulations appear to directly preclude preemption,” but once again the cited regulation defines the scope of the Medical Device Amendment’s express preemption provision.  That provision did not apply, nor did the defendants argue that it should. Id. at *13.

Finally, the court observed that 510(k) clearance does not preempt “state statutes of general application.” Id. at **13-14.  Of course the mere fact of 510(k) clearance does not create a blanket of preemption over “statutes of general application,” and we highly doubt the defendant argued that it did.  However, when the plaintiffs is claiming that a medical device manufacturer violation a state statute of any kind because its conduct violated the FDCA, that’s implied preemption, and that is exactly what the plaintiffs alleged here.

In the end, we have a class action alleging that “FDA approved” and “FDA cleared” are different enough to consumers that the law should require awarding damages to patients who allege no injury and for whom the device may have worked exactly as advertised. We are not so sure, nor are we sure that this order will survive an appeal.

A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of the devices’ 510(k) regulatory pathway.  Most or all of these orders rely on the Supreme Court’s 1996 opinion in Medtronic, Inc. v. Lohr, where the Court held that federal law did not preempt certain medical device warnings claims involving 510(k) devices.  In so holding, the Court distinguished the pre-1990 510(k) clearance process from the more involved and “rigorous” premarket approval (“PMA”) process and observed that the old 510(k) process was “focused on equivalence, not safety.”  518 U.S. 470, 493 (1996).

The Supreme Court did not hold that 510(k) clearance has no bearing on safety and efficacy, but the language quoted above provides a foothold for those inclined to marginalize the FDA’s role.  Indeed, we believe the Supreme Court’s view of the 510(k) process was already outdated in 1996.  As we have explained multiple times (including here), the 510(k) clearance process is keyed directly to safety and efficacy, and the Supreme Court has been retreating from Medtronic v. Lohr almost since the day the opinion was filed.

A district judge in Los Angeles recently provided what we think is the correct perspective. The case is Otero v. Zeltiq Aesthetics, Inc., No. CV 17-3994, 2018 WL 3012942 (C.D. Cal. June 11, 2018), and it is not a preemption case, or even a product liability case.  Instead, patients sued the manufacturer of a non-invasive fat-reducing system under California’s permissive consumer fraud statutes, claiming that the company made partial statements that were misleading and failed to disclose material information about the product. Id. at **1-2.

What were the misleading partial statements and omitted facts? The plaintiffs alleged that the manufacturer stated (truthfully) that the product was “FDA-cleared” and “FDA-cleared as safe and effective.” Id. at *1.  And the manufacturer failed to explain the difference between “FDA clearance” on the one hand and “FDA approval” on the other.  That’s the omission.

We have unending sympathy for individuals who fight weight gain and for whom the condescending admonition to exercise more and eat less is not helpful. Be that as it may, these claims have no arguable merit, and the district court correctly dismissed them.  With regard to the alleged “partial” representation that the device was “FDA cleared,” the district court ruled that “Plaintiffs fail to explain how that true representation—on its own—could cause reasonable consumers to erroneously believe that the system received FDA approval.” Id. at *2.  The court continued:

Plaintiffs simply point out that under California law, true statements may mislead reasonable consumers if other relevant information is omitted. Although that is an accurate legal proposition, it does not establish that “FDA-Cleared” gives rise to viable [California statutory] claims, especially because the “mere possibility” that some consumers acting unreasonably will conflate FDA-clearance and FDA-approval is insufficient.

Id. So can a true statement ever support a claim?  Under some circumstances not presented here, it appears that one could, although that would be truly exceptional case.  Can a true statement support a claim where it is merely possible that a consumer will unreasonably misconstrue it?  This court ruled that it cannot.

There is more. The plaintiffs also argued that adding the words “safe and effective” to “FDA-cleared” was misleading because that claim can only be made in connection with FDA approval, citing Medtronic v. Lohr.  (See, we were going to get back to Medtronic v. Lohr eventually, and here we are).  In the part of the order that we like the most, the district court convincingly debunked the myth that “safe and effective” is unique to the PMA process:

It appears that this argument relies on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which allegedly establishes that “‘[t]he § 510(k) notification process is by no means comparable to the PMA process’ and in no way warrants that the device is safe and effective.”  [quoting Plaintiffs’ brief.]  Although Medtronic observed that obtaining Section 510(k) clearance is not as onerous as the “rigorous” PMA process, the Supreme Court did not find that the former has no bearing on a device’s safety and effectiveness. In fact, Medtronic acknowledged that “the FDA may well examine § 510(k) applications . . . with a concern for the safety and effectiveness of the device . . .”  The Supreme Court later clarified “the FDA simultaneously maintains the exhaustive MPA and the more limited § 510(k) process in order to ensure . . . that the medical devices are reasonably safe and effective.

Id. at *3 (first emphasis added, second in original).  In other words, the plaintiffs (and others before them) were relying on a snippet to misread Medtronic and overstate its holding.  The district court went on to state that the FDA’s regulations connect 510(k) clearance to safety and effectiveness, too:

Indeed, the FDA regulations provide that if the agency has found that a device is substantially equivalent to—but has “technological characteristics” that are different from—a predicate device, then that means the agency has concluded that “[t]he data submitted . . . contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device.”

Id. (emphasis in original).  Finally, the district court noted that compliance with general and special controls, which Class II medical devices must do, further provides “reasonable assurance of the safety and effectiveness of the device.” Id. There was no deceptive, no misleading statement.  Only true representations of a medical device’s regulatory pathway.  That is not the basis for a consumer fraud claim.

Nor is it consumer fraud when a manufacturer does not explain the difference between FDA clearance and FDA approval. The district court ruled that a manufacturer’s duty to consumers is limited to warranty obligations, absent an affirmative misrepresentation or a “safety issue.” Id. at *4.  We are not sure this is an accurate statement of a medical device manufacturer’s duty to consumers, especially considering the presence of prescribing physicians (i.e., the learned intermediaries) for many devices.  We also can’t imagine a situation where a medical device manufacturer would be under a legal obligation to explain FDA regulations to consumers.  But even taking the rule at face value, the plaintiffs alleged no safety risk. Id. at *5.  Maybe they were unsatisfied with the results (i.e., effectiveness) and wanted their money back.  Whatever their beef was, it was not about safety.

The plaintiffs walked away with their core claims dismissed without leave to amend. The district court gave them another chance to plead that they actually observed other statements that they claimed were misleading, based on counsel’s representations at argument that their clients might have seen them. Id. at **5-6.  We don’t know.  It seems to us that if those facts existed, the plaintiffs would already have pleaded them.  The takeaway for us is the reality that the 510(k) process does tie into safety and efficacy.  Don’t let anyone tell you otherwise.

We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic.  That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA.  As we have said here and here (and other places), we are not convinced that such a duty even exists.  That is why we liked the district court’s order from last year dismissing the Complaint in Ebrahimi v. Mentor Worldwide LLC, mainly because the district court emphasized another befuddling aspect of Stengel:  How on Earth can a plaintiff plead and prove that a purported failure to report adverse events to the FDA caused him or her any injury?

The plaintiff in Ebrahimi could not allege causation last year, and despite multiple opportunities to amend, she still can’t, resulting in another order granting another motion to dismiss.  The order is Ebrahimi v. Mentor Worldwide LLC, No. 16-cv-7316 (C.D. Cal. May 25, 2018) (you can view the order here), and the pleading at issue was the Second Amended Complaint.  The plaintiff again alleged injuries resulting from treatment with silicone-gel breast implants, and as in the initial Complaint, she alleged two failure-to-warn theories:  (1) The defendant allegedly failed to report “adverse events” to the FDA, and (2) the defendant allegedly failed adequately to warn patients and doctors. Id. at 3.

But neither of those theories stated a parallel claim sufficient to avoid express preemption. The Medical Device Amendments expressly preempt any state-law requirement that is “different from or in addition to” any federal requirement related to safety or effectiveness. See 21 U.S.C. § 360k(a).  Under the much-misunderstood “parallel claim” exception, a plaintiff can sometimes plead a non-preempted state-law claim if the asserted state law duty “parallels” the federal requirement.  Theoretically, that claim would not be “different from or in addition to” federal requirements.

The alleged failure adequately to warn doctors and patient was clearly preempted. Imposing a state-law duty to warn that is different from what federal law requires runs headlong into the Medical Device Amendments’ express preemption provision.  That is Riegel v. Medtronic to a tee.

As for the alleged failure to report adverse events to the FDA, that was not an actionable “parallel claim.” As the district court observed, “To state a parallel claim under California law, Ebrahimi ‘will ultimately have to prove that if [the manufacturer] had properly reported the adverse event to the FDA as required under federal law, that information would have reached [her] doctors in time to prevent [her] injuries.’” Id. at 3 (quoting Stengel v. Medtronic, Inc., 704 F.3d 1224, 1234 (9th Cir. 2013)).

Of course, this gloss on a parallel claim assumes that a state-law claim for failure to report claim to the FDA actually exists, and we don’t think one does. But setting aside that fundamental disagreement, this district court has again correctly zeroed in on causation as essential to pleading a claim based on an alleged failure to report adverse events.  This plaintiff failed for two reasons.  First, the “adverse events” that she alleged were not “events” at all.  Plaintiff alleged “potential statistical issues” with six post-approval studies, but none of those “issues” was an “ailment or injury resulting from gel bleed.” Id. at 3-4.  Second, and we think more importantly, the plaintiff failed to allege a “causal nexus” between her injuries and the manufacturer’s alleged failure to report:

In particular, she does not allege any specific facts showing that had [the manufacturer] not “covered up” these purported adverse events, the FDA would have required [the manufacturer] to modify its labeling and marketing materials or otherwise warn patients and doctors that “significant gel bleed was a potential risk. . . .” Therefore, Ebrahimi’s failure-to-warn claim cannot escape express preemption because she has not shown that [the manufacturer’s] failure to report adverse events to the FDA resulted in her injury

Id. at 5. We have blogged on parallel claims on multiple occasions, but Ebrahimi is particularly strong on folding causation (or lack thereof) into defining which claims avoid express preemption and which do not.  This is more than TwIqbal.  This is a district court ruling that federal law preempts your claim unless you can allege specific facts showing that the violation of a “parallel” state-law duty actually caused you harm.  Other courts should do this, too.

This time around, the district court dismissed the failure-to-warn claims without leave to amend, which makes sense. The plaintiff filed a First Amended Complaint, and then a Second, and if she has not alleged a non-preempted claim by now, she never will.  The district court did grant leave to amend for the manufacturing defect claim, based on allegations that the implant suffered from “poor workmanship” and the like. Id. at 5-6.  So she gets another chance, but if all she is left with is a manufacturing defect claim in a medical device case, she does not have much.

Kudos to the attorneys at Tucker Ellis for achieving this result, and our thanks to Dustin Rawlin for sending the order our way.

The Nebraska Supreme Court issued a gem of a Daubert opinion in an Accutane case last week, Freeman v. Hoffman-La Roche, Inc., No. S-17-800, 2018 WL 2296772, at *2 (Neb. May 18, 2018).  We don’t write much about Nebraska, but the last time we waxed on about the beauty of the Platte River Valley, we actually received a few emails.  That was when we wrote last year about the Daubert order that the Nebraska Supreme Court has now affirmed, in an opinion that is as correct and straight-headed as the order it was reviewing.  Indeed, the current opinion might actually be the end of this case, which has been kicking around in the Nebraska state courts amazingly since the late 1990s.

Nebraska keeps a low profile. Growing up in California, we were told that Nebraska is in the Midwest.  But then we went to college in New England and learned that Nebraska is just plain “West,” unqualified by any prefix.  Sandwiched in between Colorado and Iowa, we suppose that either moniker could justifiably apply.  Nebraska has the country’s largest railyard, including a tall public viewing tower from which you feel as if you are looking down on a sprawling model train set.  We know because we have been there.  We had a few hours to kill in North Platte one day (don’t ask why) and we Googled “things to do in North Platte.”

There is a city in Nebraska named Kearney and a street in San Francisco named Kearny. They are spelled differently and pronounced differently (Nebraskans say Car-nee,” while Californians say “Ker-nee.”).  But they are named after the same guy.  Go figure.

Legalwise, Nebraska is the only state with a unicameral legislature—i.e., one chamber, with no separate house and senate.  The Nebraska state motto is “Equality Before The Law.”  We like that motto a lot, and we were even more impressed when we learned that it predates the Fourteenth Amendment by one year.  We begrudgingly admit that we prefer “Equality Before The Law” over our home state’s motto, “Eureka!”  The former echoes a bedrock principle of our post-Civil War legal tradition and is both declaratory and aspirational.  California’s motto celebrates sudden wealth.  Must have been sponsored by plaintiffs’ lawyers.

We like the Nebraska Supreme Court’s opinion in Freeman v. Hoffman-La Roche a lot, too.  The plaintiff was prescribed Accutane for chronic acne and allegedly experienced Crohn’s disease in her colon and rectum as a result.  2018 WL 2296772, at *2.  There is, however, no reliable scientific evidence showing a causal relationship between Accutane and this particular condition, so when it came time to produce the expert opinions necessary to prove her claims, the plaintiff could not come through.

She banked on a single expert, whom the trial court found to have applied an unreliable methodology and who “unabashedly cherry-picked supporting studies from an overwhelming contrary body of literature.” Id. The trial court’s 42-page order is among the more thorough orders on expert opinion that you will see, and you can review our take on it here.  It’s a strong order showing that the trial court understood who this expert was and what he was offering.

The Nebraska Supreme Court agreed, and it affirmed the exclusion of the expert’s opinions and the trial court’s order granting summary judgment. The Nebraska Supreme Court must have been as impressed with the trial court’s order as we were, because it affirmed the result in just a few pages.  Under Nebraska’s standard—known as the Daubert/Schafersman framework—the court must determine whether an expert’s methodology is reliable and whether the expert applied the methodology properly to the facts. Id. at *3.

This expert employed a “weight of the evidence” methodology, under which he purported to form an opinion based on a variety of disparate data—animal tests, case reports, epidemiological studies, etc. Id. at *4.  That methodology, according to the Nebraska Supreme Court, is generally accepted.  But the problem was and remains that the expert did not apply the methodology in a reliable fashion. Id. He recognized that there was no study determining that Accutane use was a risk factor for Crohn’s disease, but theorized that it would be a risk factor for a particular type of Crohn’s disease—Crohn’s disease of the colon.

Where did he get that? Well, essentially from nowhere.  He disregarded all but one of the epidemiological studies finding no significant relation between Accutane use and irritable bowel syndrome, which is a disease of the colon.  He also found studies reporting no association between Accutane use and Crohn’s disease a “waste of time” because they did not account for the “different manifestations” of Crohn’s disease.  He admitted, though, that the scientific community does not agree that “different manifestations” of Crohn’s disease make any real difference.  He also admitted that Crohn’s disease has a different clinical presentation and different causes than ulcerative colitis, but then he still relied on one study on ulcerative colitis to support his causation opinion. Id. at *4.  So Crohn’s disease is different, except when it isn’t.

Most tellingly, the expert rejected epidemiological studies on Crohn’s disease that showed no association because they did not focus narrowly on Crohn’s disease of the colon.  But then he relied on anecdotal case reports of Crohn’s disease in Accutane patients whether they reported disease of the colon or not.  So the location of the disease was critical when it helped him, but was immaterial when it did not.  As we said before, this is called talking out of both sides of your mouth, and it is neither good nor scientific.

Taking its cue from the trial court, the Nebraska Supreme Court thus concluded:

The objective of the trial court’s gatekeeping responsibility is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field. Clearly, cherrypicking studies from an overwhelming contrary body of literature without valid, supporting reasons for why the other studies were disregarded does not meet the standard of intellectual rigor required of expert witnesses.

Id. at *5.  Without admissible expert opinion, the plaintiff tried to fill the gap with “internal documents,” but that fell short, too.  To the extent the documents were in the record, they did not show a causal relationship.  Id.  Summary judgment affirmed.  This expert’s opinion was shallower than the Platte River itself—a mile wide at its mouth and six inches deep, as some Nebraskans like to say.  We got that saying, by the way, from Bexis.

A case from Alabama this week got us to thinking about two topics on which we write a lot — innovator liability and personal jurisdiction. We thought the most interesting part of Bexis’ recent post on innovator liability was its suggestion that innovators sued over the use of generic drugs should consider objecting to jurisdiction.  After all, it is one thing to say that an innovator manufacturer can be potentially liable for a generic manufacturer’s warnings under state tort law.  It is a fundamentally different question whether the innovator manufacturer can be subject to personal jurisdiction in that state under the U.S. Constitution.  The plaintiff’s use of the generic drug cannot alone support specific personal jurisdiction over the innovator for the simple reason that the innovator did not make or sell the drug.

How does any of this relate to the aforementioned case from Alabama? Well, what if an enterprising plaintiff argued that a prescription drug manufacturer is subject to personal jurisdiction in the forum state because the manufacturer submitted a New Drug Application for its product to the FDA.  Seems like a strained proposition, but that is what the plaintiff argued in Blackburn v. Shire U.S., Inc., No. 2:16-cv-963, 2018 U.S. Dist. LEXIS 78724 (N.D. Ala May 10, 2018).  Innovator liability was not at issue in Blackburn, but innovator manufacturers are all NDA holders.  Thus, if the Blackburn plaintiffs are correct and merely submitting an NDA can result in personal jurisdiction in distant forums, then innovators will not get very far with the jurisdictional challenges that Bexis has suggested.

Fortunately, the district court in Blackburn faithfully applied the law and properly rejected NDA-based personal jurisdiction.  The plaintiff took a prescription drug and sued five different companies with “Shire” in their names over allegedly inadequate warnings after developing a kidney injury. Id. at **1-2.  The district court dismissed three of the defendants for lack of personal jurisdiction, but the plaintiff later moved to reinstate one of them, the holder of the drug’s NDA. Id. at **3-4.  According to the plaintiff, the court could exercise specific jurisdiction because the defendant, “as the NDA holder” for the drug, “placed [the drug] into the stream of commerce to reach Alabama consumers, such as himself.” Id. at *16.

The issue was specific jurisdiction, and the district court started by quoting BMS:

In order for a state court to exercise specific jurisdiction, the suit must arise out of or relate to the defendant’s contacts with the forum.  In other words, there must be an affiliation between the forum and the underlying controversy, principally, an activity or an occurrence that takes place in the forum State and is therefore subject to the State’s regulation.  For this reason, specific jurisdiction is confined to adjudication of issues deriving from, or connected with, the very controversy that establishes jurisdiction.

Id. at *15 (quoting Bristol-Myers Squibb v. Superior Court, 137 S. Ct. 1773, 1780 (2017) (emphasis in original).  As a general rule, it is not sufficient that a defendant might have predicted that its goods would reach the state.  Rather, the defendant must have “targeted” the forum and “purposefully availed itself of the privilege of conducting activities within the forum.” Id. at **15-16 (citations omitted).

The plaintiff did not dispute that the defendant had not actually manufactured or sold the drug. Instead, the plaintiff contended that the defendant, as the NDA holder, should be deemed a “manufacturer” for jurisdictional purposes.  The district court had little difficulty rejecting these “semantics.” First, the plaintiff argued that the defendant established sufficient minimum contacts when it sought permission from the FDA to manufacture, market, and sell the drug in Alabama and other states.  But merely seeking permission from the FDA or submitting an NDA “does not rise to the level of targeting Alabama or invoking the benefits and protections of its laws (especially when none of these activities occurred within Alabama or were directed at Alabama).” Id. at *17

Second, the plaintiff argued that the defendant purposefully availed itself to Alabama by crafting a “defective label that it knew would be purchased by Alabama residents.”  But this is just a version of “the defendant might have predicted its product would be sold in the state,” which is not sufficient to establish personal jurisdiction. Id. at *17. Third, the plaintiff argued that the that the actions of the entities that actually sold the drug should be attributed to the defendant under some sort of alter ego theory, but the plaintiffs’ proposed amended complaint did not allege any facts supporting such a theory. Id. at *17-18.

There are other aspects to the order, but jurisdiction over the NDA holder is what caught our eye. Although we are not fond of saying that an argument “proves too much,” we think that statement applies here.  If merely submitting an NDA creates personal jurisdiction in Alabama, then it would arguably create personal jurisdiction in any state within the FDA’s regulatory reach, i.e., within the United States and its territories.  “NDA holder jurisdiction” would therefore be a form of universal jurisdiction that the Supreme Court condemned in Bauman.  It does not fly.  So for now, Bexis’ advice to innovators remains sound.  Innovators and NDA holders can and should consider challenging personal jurisdiction in cases where they did not make and did not sell the drug at issue.

The Eleventh Circuit has lately become a bit like Forest Gump’s box of chocolates—you never know what you’re going to get. The news today is positive.  The Eleventh Circuit recently issued a gem of an opinion on the learned intermediary doctrine under the law of Alabama, which also happens to be the home of the aforementioned Mr. Gump.

The Eleventh Circuit is not always so good. While the court got everything right in Tutwiler v. Sandoz, Inc., No. 17-13985, 2018 WL 1719024 (11th Cir. Apr. 9, 2018), readers of our 2017 Ten Worst post will recall that the Eleventh Circuit issued three of the ten worst drug and device opinions of 2017, making it 2017’s most noteworthy performer among the circuits.  Maybe we can read something into that.  Or maybe it was fate, like a feather floating in the wind.  After all, if Forest Gump taught us anything, it was that history is arbitrary and that sometimes bad things happen to good people.  The latter, of course, is a reference to Forest’s hard-luck childhood friend Jenny, played beautifully by a young Robin Wright in a performance that was both poignant and memorable.  (Much different, by the way, from Wright’s more recent portrayal of an Amazon warrior in 2017’s reboot of Wonder Woman, which awkwardly fell flat in what was otherwise a perfectly decent superhero film.  We have not yet binged the last season of House of Cards on Netflix, so we will withhold comment on Wright as the relentlessly power-hunger President Claire Underwood.  But we digress.)

So what flavor did the Eleventh Circuit recently give us on the learned intermediary doctrine? A good one, or two, or even three.  In Tutwiler, the plaintiff alleged that she suffered pulmonary issues as a result of taking generic amiodarone for non-life threatening atrial fibrillation.  2018 WL 1719024, at *1.  According to the plaintiff, she did not receive the patient Medication Guide that the manufacturer allegedly made available to distributors and thus did not know that her doctor prescribed the drug off label. Id.

The district court dismissed the plaintiffs’ failure-to-warn claims on two bases: (1) federal regulation of generic drug warnings impliedly preempted the state-law warnings claims and (2) the learned intermediary doctrine barred the plaintiff’s claims absent allegations that inadequate warnings to the physician proximately caused the alleged injury. Id..  The Eleventh Circuit affirmed under the learned intermediary doctrine.  This is slightly surprising, given that the Supreme Court’s opinion in PLIVA v. Mensing provides such a clear path to implied preemption in failure-to-warn claim involving generic drugs.

Regardless, the Eleventh Circuit’s opinion on Alabama’s learned intermediary doctrine is in equal parts concise and well reasoned. There are three takeaway points. First, the plaintiff alleged that her physician prescribed the drug off label.  But that did not make a difference to her failure-to-warn claims, nor should it have made a difference.  We have seen other plaintiffs try to establish or amplify failure-to-warn claims by highlighting that their physicians prescribed drugs off label.  It usually does not work, for the simple reason that a prescription drug manufacturer has a duty to warn about known and reasonably knowable risks, not uses.  Of course, some states’ laws might impose a duty to warn regarding dangers of a product’s foreseeable misuse.  Be that as it may, a bare allegation of off-label use does not an inadequate warning make.

Second, and most importantly in our view, the Eleventh Circuit rejected the argument that the learned intermediary doctrine did not apply because the drug manufacturer did not adequately warn the plaintiff’s physician—and all other physicians—of the drug’s dangers.  In other words, the physician lacked sufficient information to be considered a “learned” intermediary. Id. at *3.

We have seen this argument before too, and a small number of courts have regrettably fallen for it. It is nonsense.  The learned intermediary doctrine is not so named because drug and medical device manufacturers have a duty to create “learned intermediaries.”  The manufacturer’s duty is to warn about a product’s known and knowable risks, and the learned intermediary doctrine defines to whom that duty is owed—highly educated physicians who are already “learned.”  This in turn defines the two critical elements of a warnings claim in drug and medical device cases:  (1) whether the warnings are adequate and (2) whether any inadequacy in the warnings caused the alleged injury.  Those elements are defined by reference to a reasonable physician’s skill and knowledge (his or her “learnedness”) and the warnings’ impact on the prescribing physician’s conduct.

The Eleventh Circuit explained it this way:

[I]n Alabama, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product. The adequacy of the manufacturer’s warning is “measured by its effect on the physician, [ ] to whom it owed a duty to warn, and not by its effect on the consumer.”

. . . . In such a situation [where the patient alleges inadequate warnings] the patient must show that:  “[T]he manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient’s injury.  In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient.”

Id. at **2-3 (citations and quotations omitted).  In Tutwiler, the plaintiffs alleged that the drug warnings were insufficient, but that alone does not erase the learned intermediary doctrine.  She also had to allege causation.  That is where she failed:

On appeal Ms. Tutwiler again argues that the learned intermediary doctrine does not apply because she alleged that [the manufacturer] did not adequately warn Dr. Plumb. This argument, however, does not address Alabama’s separate requirement that she also plead proximate causation—that Dr. Plumb would not have prescribed her amiodarone had he known of its dangers.

Id. at *3.  Because the plaintiffs did not allege that different or additional warnings would have changed her physician’s prescribing physician, she failed to allege causation, and the learned intermediary doctrine barred her claim. Id.

Which brings us to our third takeaway.  The plaintiff could not avoid the learned intermediary doctrine by alleging that she would have avoided the drug had she known of its dangers.  “Regardless of what Ms. Tutwiler would or would not have done with the information, Alabama law requires a showing of what Dr. Plumb would have done with it.” Id. (emphasis in original).  Plaintiffs routinely give self-serving testimony or execute affidavits attesting that they would not taken the drug “had they known.”  That won’t work, at least not in Alabama.

The opinion’s only drawback is that it is not published. Still, the Eleventh Circuit has set a tone that we hope will continue throughout 2018 and beyond.  Run Forest Run.