For the better part of a decade, Bexis has participated in the Food & Drug Law Institute’s (“FDLI”) annual Top Food and Drug Cases project.  For 2019, he wrote about (surprise!) Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  These haven’t been discussed previously on the Blog because, due to the publication process, these articles are not particularly timely, particularly when judged by the speed of time on the Internet.  However, the impact of COVID-19 slowed FDLI’s publication process more than usual this year, and Bexis was given the opportunity to update his Albrecht article shortly before publication.  This article has now been published, and it is timely.

Here’s a link.  Here is the necessary legalism:  Shared with the permission of FDLI.  Here, moreover, is a link to the entire FDLI top cases publication for 2019.

Should you bother clicking on the link?  Well, here are some of the topics Bexis’s article addresses:

  • The reasons why preemption should be treated as a question of law.
  • All preemption issues being questions of law.
  • Impact of question of law ruling on use of expert witnesses in preemption litigation.
  • The standard of review for judicial factfinding.
  • “Clear evidence” after Albrecht
  • Albrecht’s emphasis on “formal” FDA procedures
  • FDA citizen petitions as a “formal” FDA procedure
  • Implications and proof of “fully informed” FDA element
  • The post-Albrecht rise of the “newly acquired information” prerequisite for utilization of unilateral “changes being effected” label changes

While there is probably nothing in Bexis’s article that we haven’t blogged about somewhere, the article does provide a useful Albrecht overview, with current citations, and consolidates these discussions in one place.

Kelly v. Ethicon, Inc., 2020 U.S. Dist. LEXIS 191665 (N.D. Iowa Oct. 16, 2020), is a remanded pelvic mesh case. The complaint included the usual panoply of causes of action for negligence, strict liability, fraud, and breach of warranty. Failure to warn, as usual, was central to the plaintiff’s case.

During the years while the case was in the MDL in West Virginia, the plaintiff in Kelly did not depose the implanting surgeon. This inactivity continued after remand to the Northern District of Iowa. Only after the defendant obtained partial summary judgment, in significant part because there was no evidence of warning causation, did the plaintiff belatedly seek to take the implanter’s deposition, along with seeking reconsideration of the summary judgment.

Leave to take the deposition was denied for lack of any good cause for the delay. The plaintiff had missed the discovery deadlines. Whether applying Fed. R. Civ. P. 16(b) or 60(b), the Kelly court found no good reason, no excusable neglect, for the plaintiff’s failure to depose the implanter. Even if it took skip-tracing to track the doctor down, the plaintiff lawyers could have done so sooner. They bemoaned their allegedly heavy workload – 26 cases within the particular “wave” of MDL cases. Too bad. The court had no sympathy. Nor should it have. Let’s face it: 26 isn’t that many, there was plenty of time, and why file cases if you cannot work them up properly?

Denied the opportunity to depose the implanting doctor, the plaintiff’s reconsideration motion was doomed. But the plaintiff went through the motions, so did the Kelly court, and so shall we.

The plaintiff tried to save its failure to warn claim by arguing that the learned intermediary rule does not apply in Iowa. The Kelly court disagreed, holding that Iowa would follow the learned intermediary rule. The plaintiff next argued that even if the learned intermediary rule applied in Iowa, it was called off in this case because of the physician’s lack of knowledge of the relevant risks. But the physician’s lack of knowledge was purely speculative (remember – no deposition), and the exception makes no sense.

The plaintiff next argued that she should have been permitted an opportunity to make out a case of failure to warn post-sale. There were several problems with that argument. The plaintiff had never before claimed post-sale failure to warn, no Iowa precedent supports a post-sale duty to warn, and, even if it did, the learned intermediary rule would still apply and the plaintiff would again lose on warning causation for not deposing the implanter.

Also denied was the plaintiff’s attempt to rescind her abandonment of design claims.

The defendant’s victory went beyond preserving the partial summary judgment. For, you see, the defendant had also filed a motion. The defendant sought leave to file a successive summary judgment motion on the statute of limitations to get rid of the remaining claims. The only cause presented for the late summary judgment motion was judicial efficiency. No problem. It is never too late for judicial efficiency. The Kelly court found that “it is ultimately in the interest of all involved to address the statute of limitations issue on a successive motion for summary judgment rather than ignoring it until trial.”

As a defense lawyer reading the Kelly opinion, we have to wonder, like the resurrected baseball player in Field of Dreams, is this Heaven?

No. It is the Northern District of Iowa.

It’s a unique relationship based largely on knowledge and trust.  Doctor’s not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient.  Knowledge that often develops overtime through trust.  Patients want and need to be able to trust their doctors.  Sometimes patients share information with their doctors before anyone else in their lives.  It’s a consensual relationship but it’s also a fiduciary relationship where the doctor takes on certain obligations.  And, it’s a relationship that has been evolving over the last several decades which numerous influences such as managed care, direct-to-consumer advertising, internet medical information.  Things that can interfere in the traditional doctor-patient relationship.  Some of that, like more knowledgeable patients who want to partner in their healthcare, can be good developments.  Managed care – removing a patient’s choice of physician or a physician’s choice of treatment – perhaps not so much.

Here, in the DDL world, we are firm believers in the independent practice of medicine.  Doctors making patient-specific medical decisions based on all known and available information, but not dictated by either drug/device manufacturers or the FDA.  That means doctors are free to use drugs and devices in ways other than their approved uses.  Doctors can use drugs and devices off-label.  And, that is what is at the core of the decision in Smith v. Surgery Center at Lone Tree, LLC, 2020 WL 6066273 (Col. Ct. App. Oct. 15, 2020).

This is a hospital liability case.  Plaintiff received a series of epidural steroid injections at defendant hospital that left her permanently paralyzed below the waist.  Id. at *1.  Plaintiff’s doctor used a corticosteroid that had not been FDA approved for epidurals.  Id. at *2.  Plaintiff sued and settled with the physician who performed the procedure.  Id. at *1.  Plaintiff proceeded with her claims for corporate negligence, uninformed consent, and negligence per se against the hospital.

Plaintiff argued that the hospital had a duty to “prevent” the doctor from using the drug off-label or to ensure that the plaintiff gave her informed consent to the off-label use.  Id. at *2.  Colorado applies the corporate practice of medicine doctrine, “which prohibits a corporation that employs a physician from interfering with the physician’s medical judgment.”  Id. at *3.  It may be a hospital case, but we’ve argued the following in products cases as well:

The decision to administer a certain medication to a patient in a certain situation is, without question, a medical decision made by a physician alone.

Id. at *4.  Not the drug manufacturer, not the sales rep, not the FDA, and not the hospital.  Plaintiff claimed that simply by making the drug available in the hospital, the hospital had an obligation to dictate how physicians used it.  Fortunately, the court rejected the argument.  A decision to the contrary would have us wondering about the ramifications for manufacturers.  You get a drug approved for one use and that makes you the watchdog to make sure doctors don’t use it off-label.  If hospitals can’t interfere with the practice of medicine, neither can manufacturers.

On the issue of informed consent, the court ruled that providing the patient with the necessary information to obtain informed consent is the practice of medicine, and therefore not the hospital’s responsibility.  If the hospital undertook to advise the patient, it would be unlawfully practicing medicine.  If it didn’t, it would violate the duty of care plaintiff wanted to impose.  The court was unwilling to put the hospital in that no-win situation.  The court also recognized that forcing the hospital to interfere in the doctor-patient relationship was problematic because it is “the surgeon, and not the hospital, who has the technical knowledge and training necessary to advise the each patient of the risk of the surgery.”  Id. at *6.  That’s why we have the learned intermediary rule in products cases.  It would be just as problematic for a drug manufacturer to step in the shoes of the doctor and give a patient advice about whether or not she should undertake a certain course of treatment.

There is also the question of whether informed consent is necessary for an off-label use.  While that question wasn’t before the court, id. at *7, the decision does include a footnote that indicates sympathy for the proposition that the FDA regulatory status of a drug is not a proper subject for informed consent.  Id. at *10n.3.

The court also dismissed plaintiff’s claims for negligence per se for off-label use that supposedly violated certain state and federal regulations because those regulations related to licensing.  To be the basis for negligence per se, the regulations needed to have been enacted for public safety and intended to protect people like plaintiff from the type of injury plaintiff suffered.  Without that, plaintiff could not sustain her negligence per se claim.

Big win for hospitals, physicians, and off-label use in general.

The Pelvic Mesh MDLs are now all but over, with all but a few stragglers either settled or remanded.  But the specious logic used in that litigation to overturn decades of precedent that had recognized compliance with FDA regulatory actions as relevant and admissible evidence, is still afoot to haunt medical device manufacturers.  As we’ve discussed, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had nothing to do with evidence or common-law issues.  It was a preemption case, and the phrase that was latched upon in that litigation – “the 510(k) process is focused on equivalence, not safety,” id. at 493 – isn’t even true anymore, as the Supreme Court subsequently recognized in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349-50 (2001) (§510(k) clearance intended “to ensure . . . that medical devices are reasonably safe and effective”); cf. In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067, 1074-75 (9th Cir. 2020) (device specific “special controls” imposed through §510(k) process may be preemptive if “relevant” to the claims at issue).

In Pelvic Mesh, this misuse of Lohr nullified state compliance presumption statutes nationwide, since such statutes serve no purpose where design defect claims are preempted and (in Pelvic Mesh) compliance became irrelevant in §510(k) cases.  These rulings served to induce settlement, since they ensured that no Pelvic Mesh design defect case would ever be dismissed as a matter of law.  To further enable design defect claims, Pelvic Mesh decisions attacked the “unavoidably unsafe” provision of Restatement (Second) of Torts §402A, comment k (1965), which, in a number of states such as California, New York, and Pennsylvania, had been applied across the board to all prescription medical products.  See, e.g., Mullins v. Ethicon, Inc., 117 F. Supp.3d 810, 820 (S.D.W. Va. 2015) (calling comment k – which almost every state follows in one form or another – a “useless relic”).  Contra Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996); Brown v. Superior Court, 751 P.2d 470, 481-483 (Cal. 1988); Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75-76 (2d Cir. 1993) (applying New York law).

The Pelvic Mesh idea that created an all or nothing approach where FDA requirements are either conclusive or irrelevant, with no middle ground, has been rejected in other MDL litigation, but it still persists.  Today’s case, Taupier v. Davol, Inc., 2020 WL 5665565 (D. Mass. Mag. Sept. 23, 2020), is an example of how Lohr continues to be misused.  Massachusetts, like the aforementioned states, has applied although the precedent had been made in prescription drug cases.  See Payton v. Abbott Labs, 437 N.E.2d 171, 189 (Mass. 1982) (adopting “policy” of comment k); Burnham v. Wyeth Laboratories, Inc., 348 F. Supp.3d 109, 112 (D. Mass. 2018); Lareau v. Page, 840 F. Supp. 920, 933 (D. Mass. 1993), aff’d 39 F.3d 384 (1st Cir. 1994) (applying Massachusetts law).

Latching onto the Pelvic Mesh decisions however, the magistrate in Taupier decided – without citing a scrap of actual Massachusetts authority – to exempt medical devices from the prior Massachusetts rule that had barred strict liability design defect claims.

Although Massachusetts cases have exempted drugs from breach of warranty liability under comment k, courts in other jurisdictions that have applied comment k to bar strict liability claims for design defects in prescription drugs have distinguished drugs from medical devices based, in part, on the FDA’s “more rigorous oversight” of drugs.  Therefore, even courts that exempt manufacturers of prescription drugs from strict liability based on comment k have applied a case-by-case analysis to medical devices.

2020 WL 5665565, at *8 (citations omitted).  Taupier cited two cases, one of the Pelvic Mesh decisions and Burningham v. Wright Medical Technology, Inc., 448 P.3d 1283, 1290 (Utah 2019).  As we pointed out when Burningham was first decided, that decision also relied on the misapplication of Lohr outside of preemption that first gained traction in Pelvic Mesh.  Prior to those decisions, there was virtually no precedent for, and massive precedent against, distinguishing between prescription drugs and medical devices in the comment k/”unavoidably unsafe” product context.

That’s the bad part of Taupier, and we have to admit, it’s pretty bad.  Not a mention of the Erie principle that federal courts should not predict expansions of state tort liability.  But the decision has some redeeming features.  Plaintiff’s express warranty claim was dismissed for “fail[ure] to identify any ‘affirmation of fact or promise’ made by Defendant.”  2020 WL 5665565, at *3 (quoting Massachusetts UCC).  Plaintiff’s warning claims were also dismissed – TwIqballed, to be precise:

While recognizing that Plaintiff has not conducted discovery, he fails to offer any description of the warnings and instructions that Defendant provided or should have provided to his physician.  His assertions that he “was not informed of and had no knowledge of the known complications and risks” . . . and that the warnings and instructions were incorrect, inadequate, and incomplete are conclusory and insufficient to state a claim for negligent failure to warn.

2020 WL 5665565, at *11.  See Id. at *12 (same result for strict liability warning claim because any difference between negligence and strict liability “has effectively collapsed” in Massachusetts).

While the other rulings in Taupier are nice, they are only a silver lining around a rather dark cloud.  Overall, Taupier is yet one more reason why our side needs to find a way to have the Supreme Court re-examine Lohr itself.

Today we have another guest post from friend-of-the-Blog, Dick Dean at Tucker Ellis.  He’s familiar with the ongoing Pradaxa litigation and is pleased with the preemption pummeling Pradaxa plaintiffs have been receiving.  Here’s his post about yet another favorable decision from the state-court Pradaxa proceedings in Connecticut.  With decisions like this, who needs snap removal?  As always, our guest posters deserve 100% of the credit (and any blame) for their work.


No commentator or blog has more precisely and persistently probed preemption and its “newly acquired information” component than has the Drug and Device Law Blog.  And the Blog has done it with poetry, or at least alliteration.  If you went right to the story and didn’t savor the headlines you missed:  “Post-Albrecht Preemption Pummels Pradaxa Plaintiffs,” followed shortly by “Post–Albrecht Preemption Persistently Pummels Pradaxa Plaintiffs.”  But what started this parade was “Plaintiff’s Pyrrhic Pradaxa ‘Victory’,” reporting on Roberto v.  Boehringer Ingelheim Pharmceuticals, Inc., No. CPLHHDCV166068484S, 2019 WL 5068452 (Conn. Sup. Ct. Sept. 11, 2019).  The Roberto court found a labeling claim about the bleeding risk from a blood thinner preempted because there was no newly acquired information on a general bleeding risk that would have warranted a CBE label change.  But the trial court also found that there was sufficient evidence to sustain a verdict of a heightened risk of bleeding in GERD (gastroesophageal reflux disease) patients, specifically.  Indeed, the court concluded in Roberto that it was unclear whether information bearing on the GERD risk had been submitted to the FDA.  But the Pyrrhic Victory post recognized that the bigger picture was the general bleeding risk, and that there were only a few GERD cases in this litigation.  So the GERD finding was a pyrrhic victory.

But now even that plaintiff’s Pyrrhic Pradaxa victory has been put out to pasture.  No longer are there GERD outliers that escape preemption.

In Estep v. Boehringer Ingelheim Pharmaceuticals, Inc., No. X03 HHD CV17-6075319S, 2020 WL 5290777 (Conn. Sup. Ct. Aug. 25, 2020), the same court that decided Roberto considered a follow-up GERD case, which had an “expanded record” on the newly acquired information issue that had allowed the Roberto plaintiff to escape preemption.  Id. at *7.  The Estep Plaintiff likewise claimed the new information on the GERD issue was a European label and a 2013-2014 medical journal article.  The court again found that these items showed reasonable evidence of different or greater risks not stated in the U.S. label.  Id. at *8.  But that left the issue of “newness.”  The definition of “newly acquired information” uses phrases like “not previously submitted to the Agency” and “previously included in submissions to the FDA.”  21 C.F.R. §314.3(b).  Defendant argued that it had submitted data to the FDA that were equivalent to what plaintiff cited in the European label and the journal article—specifically, it relied on reports of bleeding in GERD patients.  Id. at *9.

Plaintiff in Estep argued that the information submitted to the FDA had to be “tethered to a proposed label change” in order to qualify as “previously submitted” to the agency.  Id.  That novel argument was to no avail.  The Court found that a straightforward application of the rules of statutory construction supported the defendant’s position.  It then looked closely at the information submitted to the agency to determine whether it was “equivalent to the claimed newly acquired information.”  Id. at *9.  The defendant pointed to several reports submitted to the FDA prior to the original approval in October 2010 that showed gastritis-like symptoms, defined to include GERD, were associated with an increased risk of GI bleed.  Id. at *13.  The court then cited almost an entire page of tables and charts linking bleeding risks in gastritis-like symptoms, which had been submitted.  Id.  In addition, in the “expanded record” defendant showed that it had submitted the very European label relied upon by plaintiffs to the FDA in September 2012, after approval but before a December 2013 label change and before plaintiff’s bleed in February 2015.  Id.

Estep is a significant decision.  It is the first holding that hard data submitted without a specific request for a label change can defeat a claim of newly acquired information.  Not that it should make any difference, but it’s another plaintiff propaganda point put down, and recognized for what it is, a distinction without a difference.

Estep stands in stark contrast to Evans v. Gilead Sciences, Inc., No. 20-cv-00123-DKW-KJM, 2020 WL 5189995 (D. Haw. Aug. 31, 2020), which the Blog discussed here last month.  That post noted the adverse warning holding in Evans that “…even if there was little or no ‘newly acquired information’ relevant to Evans’ claim, that did not make it impossible for Gilead to change its….label.”  Id. at *11.  The opinion in Estep provides a detailed refutation explaining why Evans was erroneous.  2020 WL 5290777 at *10-*11.  Estep cited to the FDA’s comments supporting the rule change in 2008 adding the concept of “newly acquired information.”  Those comments pointed out that allowing sponsors to change labeling for a product without limitation based on previously submitted information would undermine the FDA label approval process.  Id. at *11.

If a plaintiff is going to allege an inadequate warning because a CBE could have been made, then the CBE regulation’s newly acquired information prerequisite must be confronted—not glossed over.  Estep also provides an excellent summary of the law in regard to pleading “newly acquired information.”  Id. at *5-*6.  Once a defendant makes an initial showing of a preemption defense, then a plaintiff must specifically identify the “newly acquired information” he relies upon.  Numerous posts on this blog have treated this issue.  In addition to the “Pummels” posts, seeOnline Reviews Are Not ‘Newly Acquired Evidence,” “On Newly Acquired Evidence,” “‘No Newly Acquired Evidence’ Argument On Implied Preemption Gaining Traction,” and “Plaintiffs Have Burden To Plead Newly Acquired Evidence.”  As the Blog’s post about Evans discussed, that decision stumbled badly on this increasingly key pleading issue—ignoring many cases in the last three years directly on point while citing to a 2018 Ninth Circuit decision having nothing to do with “newly acquired information.”  2020 WL 5189995 at *10.

Estep underscores what an outlier decision Evans truly is.

There was an awful lot for defense counsel to contend with in Cavanaugh v. Stryker Corp., 2020 WL 5937405 (Fl. Dist. Ct. App., 4th Dist. Oct. 7, 2020).  The patient died during surgery when the defendant manufacturer’s suction device damaged his heart.  Another patient died under similar circumstances two years earlier.  The manufacturer issued a notice updating its warnings as to those circumstances five months earlier.  The FDA said that the device was potentially adulterated three months earlier.  The manufacturer issued a recall notice limiting the device’s use two months earlier.  The nurse who misused the suction device during the surgery did not read the warnings.  And the description of the patient’s death was unsettling.

But a good defense team can find within those facts, and certain others, a reasonable story to tell a jury about why they should not hold the manufacturer liable and should instead look to the medical  staff’s misuse of the device in the face of revised warnings, a recent training session and broad industry knowledge that the device should not be used in the manner that it was.  They told that story well, and the jury agreed.  (We note that the plaintiff wasn’t out of luck because she settled with the medical defendants before trial).  The trial was a big victory for the defense.

But at least as big was the defense’s victory on appeal last week.  Plaintiff challenged the trial court’s decision not to instruct the jury on the consumer expectations test for plaintiff’s design defect claim.  This challenge had support from the Florida Supreme Court, which held only five years earlier in Aubin v. Union Carbide Corp., 177 So. 3d 489, 510 (Fla. 2015), that “in approaching design defect claims, we adhere to the consumer expectations test.”

The defense, however, effectively showed Florida’s Fourth District Court of Appeals that medical devices are different from the product involved in Aubin.  Convinced, the appellate court held that Aubin was “distinguishable” because it “involved asbestos, which is not a complex product.”  Sure, “an ordinary consumer could form expectations about” asbestos.  But the “consumer expectations test cannot be logically applied” to medical devices, which are available to “an ordinary consumer only as an incident to a medical procedure.”  The suction device in Cavanaugh, not surprisingly, was never “marketed to ordinary consumers.”

In fact, any attempt to apply the consumer expectations test in Cavanaugh, if it could be done at all, would have required a modification clarifying “that the relevant expectations are those of the health care professional.”  But the plaintiff never asked for such an instruction.  And so the defense got its appellate win:

Accordingly, we conclude that the Plaintiff’s proposed [consumer expectations] instruction was not an accurate statement of the law under the specific facts of the case and would have been confusing to the jury.  We therefore find no abuse of discretion in the trial court’s decision to withhold the instruction.

The appeal in Cavanaugh involved several other issues, all of which went the defense’s way, including plaintiffs’ challenge to the trial judge’s highly unusual decision to allow peremptory strikes of alternate jurors just before deliberations were to begin.  Despite what appears to have been a tactical battle for jurors between counsel (again seemingly won by the defense), the appellate court also rejected this challenge because, in the end, the jury consisted of qualified, impartial jurors.

This was a big win.  It put into the Florida appellate books a clarification that Aubin’s consumer expectations test does not apply to medical device and, presumably, drug cases.  Shout out to Dan Rogers at Shook Hardy for his appellate win and for alerting us to the decision.

Last Saturday was World Mental Health Day. We hope you celebrated by getting outdoors in the very pleasant weather typical of early October throughout this beautiful country. We hope you also spent a few moments taking stock of your own mental wellbeing. Lawyers do not conduct such a self-assessment nearly enough. We are focused on solving the problems of our clients, issue-spotting, and scenario-spooling. It can be an unhealthful immersion in negative thinking.

Third Circuit Judge Cheryl Krause and one of her former law clerks, Jane Chong, authored a law review article at least as worthy of our attention as the latest learning on preemption or personal jurisdiction: C. Krause & J. Chong, “Lawyer Wellbeing as a Crisis of the Profession,” 71 S. Carolina L. Rev. 203 (2019). The article begins with a grim pronouncement: “The legal profession is in the throes of a mental health crisis.” The high rates of lawyer depression, anxiety, substance abuse, and suicide are alarming in themselves. They also pose a threat to the quality of client representation. Model Rule 1.1 (competence) and 1.3 (diligence) are implicated. As Arthur Miller wrote in Death of a Salesman, attention must be paid.

The Krause/Chong article builds on the lessons of self-determination theory, looking at how maladies in our profession lead to debilitating self-doubt, decreased autonomy, and diminished connectedness to others. Hours are longer, opportunities for young lawyers are reduced, commercialization is pervasive, and civility is … erratic. The article offers proposals for cultivating competence, encouraging autonomy, and modeling civility. There are many concrete suggestions, and they are all animated by a sense of reviving the concept of the legal profession as a noble calling.

Lawyers are inherently skeptical. It is part of the job description. The word “noble” might prompt embarrassment. It shouldn’t. What we do is important and the way to do it well calls upon the highest human talents. Resolving disputes via persuasion rather than force represents one of the great achievements of our species. Moreover, lawyers are overwhelmingly an intelligent, interesting lot. Even our opponents, and even those who write critical comments to this blog, are largely constructive and insightful. Smart and funny go a long way.

There is plenty of stress, to be sure. But stress represents caring for something that matters, and we’ll take that over indifference anytime. Reframe those stressors as challenges permitting you to show your stuff in a discipline that you have chosen. Put aside relentless perfectionism. If you talk to your colleagues long enough and candidly enough, you’ll realize you are not a mere imposter and are, in fact, pretty good at what you do.

Politics right now is making most of us miserable. We have friends and relatives who seem to be speaking a different language when it comes to the election. The less we say about that, the better. This too, will pass. We have much more, and much more of real significance, in common than whatever drives our quibbles. We’ll keep hitting the like button for pictures of kids and vacations, and otherwise steer clear of social media.

The pandemic is undoubtedly contributing to stress, but many of us have, mirabile dictu, overcome aversion to technology and discovered that remote meetings, depositions, and court hearings work quite well. We have learned things that we will not unlearn once we overcome Covid-19. Meanwhile, eat well, get enough sleep, and exercise. (We can introduce you to a terrific Zoom Pilates instructor.)

Finally, if you feel you need help, get it. It is out there. For example, take a look at the ABA’s directory of lawyer assistance programs.

Good luck. Stay safe. Stay well. Stay in touch.

The heat waves of summer haven’t been gone long enough for those of us in the North East to be longing for 90° days anytime soon.  But we have no problem reaching back to the dog days of summer for today’s decision.  Which got us thinking, what are the dog days of summer?  Days that are so hot all you can do is lie around like a panting dog?  Not exactly.  It turns out the dog days are typically considered to run from somewhere around July 20th to August 20th  and are said to coincide with the time when the Sun occupies the same region of the sky as Sirius, the Dog Star.  We’re sure many of you knew that already, but we (at least this member of the Blog) had to Google it.  So, yes in most parts of the United States you are talking about the hottest days of the year.  But that has nothing to do with dogs, and really nothing to do with Sirius either.  That’s just when the Earth is tilted at an angle that lets the sun’s rays hit it more directly and for a longer period of time.  And yes, we may also be eavesdropping on the virtual middle-school science class going on down the hall.

Which brings us to Cleeton v. Siu Healthare, Inc., 2020 WL 5875947 (Ill. Cir. Ct. Aug. 21, 2020), decided over a month ago just on the cusp of those dog days.  It is a defense win in another attempt by plaintiffs to avoid preemption by blaming a PMA device manufacturer’s sales representatives for not supervising plaintiff’s treating physician.  The Illinois trial court saw through the preemption dodge and granted summary judgment.

The device at issue is a multi-component drug infusion pump used in the treatment of chronic pain.  There was no dispute that it was pre-market approved by the FDA.  Therefore, plaintiff had the Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) preemption analysis to withstand – meaning his claims would be barred if they imposed any different or additional requirements beyond those mandated by the FDA.  But as that applies to the manufacturer, plaintiff opted to focus his attention on two sales representatives, suing them both.

The first question the court tackled was whether the sales representatives owed a duty to plaintiff.  The answer was no.  While plaintiff tried to recast the representatives as healthcare providers, their sole role was to provide “technical support and assistance” upon the request of a healthcare provider.  Cleeton, at *1.  The sales representatives’ job is to be available to provide information to the treating physician who in turn could use that information in his clinical judgment to treat his patient.  The sales reps “owed no duty to diagnose, . . . offer medical advice, or insert themselves into the middle of the doctor/patient relationship.”  Id. at *2.

Indeed, one of the sales reps was never present during any of plaintiff’s treatments.  Rather she was contacted about providing equipment that might be necessary to perform a procedure that the physician ultimately elected not to do.  Id.  Other than a 20-year old nursing history, the sales reps had no medical training and they were not responsible for plaintiff’s medical care.

The physician is responsible for providing medical care. Putting such a duty on the [sales reps] would exceed the scope of their duties as field representatives and impose a burden on [the manufacturer] to monitor the actions of medical providers.

Id.  The sales representatives undertook no duty beyond their role as technical support for the treating physician.

That left plaintiff’s failure to warn claim.  Here, plaintiff alleged that the sales representatives failed to give the treating physician “additional copies of the FDA-approved guidelines.”  Id.  It appears there was no argument by plaintiff that the FDA-approved guidelines were in some way deficient or inadequate.  Not that those would have survived either, but this claim is really thin.  The FDA-approved warnings are good enough, the manufacturer just didn’t give the treater an extra copy.

Plaintiff did not produce any evidence that the defendant failed to comply with FDA requirements in the distribution of its warnings.  In fact, the hospital requested a copy and defendant provided them.  Id. at *3.  Manufacturers “are not required to provide warnings above and beyond what has already been approved by the FDA.”  Id.  And, plaintiff could point to no federal requirement that defendant’s sales representatives had a duty to provide a separate copy of information that was already provided.  Because that would impose a requirement different from or in addition to federal requirements, plaintiff’s failure to warn claim was dismissed.

It was sunny and in the mid-80s in Springfield, Illinois the day this decision was entered.  A memory to cling to when the high only reaches 40° and the sun sets before 4 o’clock in the afternoon.


When we last examined the FDA’s sporadic effort to update the archaic “intended use” regulations (primarily 21 C.F.R. §§201.128 (drugs), 801.4 (devices)), the 2017 bait-and-switch amendment to these regulations had been put on ice.  That has led to the bizarre Westlaw “currentness” notice for these regulations:

<Text of section effective upon the effective date of the amendment by 82 FR 2217, delayed indefinitely by 83 FR 11639.>

First, a brief orientation.  As we’ve discussed, the FDA has largely given up trying to justify the sentence in these regulations that can be read as creating a new “intended use” based on nothing more than the regulated party’s knowledge of off-label use of its product.  In 2015, it tried to sneak through such a change, hoping to avoid First Amendment-based comments.  This Blog helped blow the whistle on that.  The final rule, however, issued in January, 2017, three days before the new administration took power, was completely different – and much worse – than the proposal had received notice and comment.  The new administration thus put that proposal into suspended animation – and that’s where it remained until just recently.

Last month the FDA decided to try again.  See Regulations Regarding “Intended Uses,” 85 Fed. Reg. 59718 (FDA Sept. 23, 2020).  First, the abortive 2017 final rule will be finally interred.  “This action will . . . repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective.”  Id. at 59718.  Second, the FDA proposes eliminate the mere knowledge language – without the 2017 bait and switch.  Here is what the new language looks like, compared to what was previously on the books (ignoring the abortive 2017 attempted change):

The words intended uses or words of similar import in [relevant substantive regulatory sections] of this chapter refer to the objective intent of the persons legally responsible for the labeling of [drugs/devices] (or their representatives). The intent may be shown is determined by such persons’ expressions, the design or composition of the article, or may be shown by the circumstances surrounding the distribution of the article.  This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.  It Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or and used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm’s knowledge that such drug was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer.  If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the [drugs/devices] article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.  But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

Added language underlined, deleted language struck through, and language differing between drug and device-related regulations in brackets.  The most critical additions and deletions are bolded.

Thus, the FDA appears to have reverted to the Agency’s original September 25, 2015, proposal simply to eliminate the 1950s-era “mere knowledge” language from its definitions of “intended use.”

Health care providers sometimes prescribe or use approved or cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients.  In such circumstances, FDA does not consider a firm’s knowledge that a health care provider has prescribed or used its approved or cleared medical product for an unapproved use to be sufficient by itself to establish the intended use element of a prohibited act related to the lack of premarket approval or clearance.

85 Fed. Reg. at 59722.  This time, however, the FDA is going about this directly, rather than hiding the proposal in an unrelated Federal Register notice (as it did in 2015).  Back then, when the Blog helped blow the whistle on the FDA’s concealment, and encouraged commentators to force the FDA to address the First Amendment implications of defining “intended use” to criminalize truthful scientific speech about FDA-regulated products.

We don’t have to do that again.  The FDA’s Federal Register notice this time around directly addresses the First Amendment.  85 Fed. Reg. at 59722-23.  The FDA continues to stick with its increasingly discredited (see, e.g., our recent Facteau post) rationale that it’s OK to chill truthful speech by consider ing it “evidence” of intent.  Id.  As we pointed out at the time (and since), the Second Circuit flatly rejected that approach in United States v. Caronia:

[E]ven if speech can be used as evidence of a drug’s intended use, we decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech.  We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.

703 F.3d 149, 168 (2d Cir. 2012).  Instead, the FDA relies on dictum in a footnote in a subsequent opinion written by a judge who had dissented in Caronia.  85 Fed. Reg. at 59724 (citing United States ex rel. Polansky v. Pfizer, Inc., 822 F.3d 613 n.2 (2d Cir. 2016)).

Good luck with that.

We fully expect that the Medical Information Working Group, the Washington Legal Foundation, and others to make their First Amendment arguments by the time the comment period ends on October 23, 2020.  If the FDA persists, then maybe the avenue for resolution of the First Amendment/truthful off-label speech issue once and for all will occur in the context of an Administrative Procedure Act appeal from the next FDA final rule.  That would certainly be a safer way for the industry to litigate this issue than to run the risk of an actual criminal prosecution.

A couple of weeks ago, we walked around the Drug and Device Law Suburban Abode with a critical eye.   The Abode was built the same year we were built, and we were struck by its similar cries for invasive cosmetic help.   As a stopgap, we arranged to have the exterior painted, a finger in the “replace all of the siding” dike.  The painter arrived, worked all day, and called us to view the results.  Sure enough, a fresh coat of paint created the illusion that someone was on top of the necessary upkeep.  Except when we looked up.  In the middle of all that was bright and new were two small dormers that had not been touched.  Upon questioning, the painter responded that we had told him what we wanted him to paint and had not included the two dormers in the current project.  Those who know us will not be surprised that our reaction was less than ladylike.  The upshot was that the painter offered (screamed) that he would throw them in “as a freebie.”  To which we responded, at a similar volume, that we had hired him, at substantial expense, to paint the outside of the house, and there was nothing “free” about finishing the job he had agreed to do.  We learned several lessons, but the one that allows us to draw a (very) tenuous connection to today’s case is that “maybe later” often is not enough.

In that vein, we are pleased to report that Illinois has joined the vast majority of states that do not permit plaintiffs to base negligence claims on “increased risk” of “maybe later” developing an injury.  This is the “medical monitoring” arena, and you can read some of our previous posts here and here and here.   And here is our “no injury” cheat sheet.  Berry v. the City of Chicago, — N.E.3d —-, 2020 WL 5668974 (2020), is not a product liability case, but its holding should delight all who defend drug and medical device manufacturers.  In Berry, the named plaintiffs were representatives of a class (these are invariably class actions) of Chicago residents whose water mains were replaced in a manner known to be associated with leaching of lead into the water.  Tests on the water in both homes revealed lead levels high enough for concern, though neither named plaintiff had any symptoms related to lead exposure.  Instead, in their negligence claim, they alleged that the City caused them and the class members “an increased risk of harm.”  Berry, 2020 Il 124999 at ¶ 28.  They sought to recover the costs of medical monitoring – of blood tests to detect the presence of lead

The City moved to dismiss the negligence claim, arguing that “increased risk of harm” was not an “injury” under Illinois law.  The City relied on Williams  v. Manchester, 228 Ill. 2d 404, 888 N.E.2d 1 (2008). In Williams, the plaintiff terminated her pregnancy after learning that her fetus was at risk for complications from an auto accident the plaintiff had suffered and from x-rays performed after the accident.  She filed a wrongful death action on behalf of the fetus. In Illinois, a wrongful death action is barred “if the decedent, at the time of death, would not have been able to pursue an action for personal injuries.”  The Williams court held that the “increased risk of future harm” to the fetus was not a “present injury,” and dismissed the case.  Fast forward to Berry.  The court explained that “the rule set forth in Williams” and other Illinois cases “is consistent with the traditional understanding of tort law,” the purpose of which is “not to punish or deter the creation of risk but rather to compensate victims when the creation of risk tortuously manifests into harm.”  2020 IL 124999 at ¶ 33 (citation omitted).  The court concluded, “A person may pursue a cause of action in tort once harm occurs.  Given this fact, there is little justification for imposing civil liability on one who only creates a risk of harm to others.”  Id.

The plaintiffs conceded that, under existing precedent, an increased risk of harm could not, by itself, form the basis of a negligence claim.  But they tried to draw a distinction, arguing that they had pled a need for medical monitoring, which was a cognizable injury.  The court wasn’t buying it, holding that “plaintiffs’ allegation that they require[d] “diagnostic medical testing” [was] simply another way of saying they [had] been subjected to an increased risk of harm.  And, in a negligence action, an increased risk of harm is not an injury.” Id., ¶ 37, citing Restatement (Third) of Torts, Liability for Physical and Emotional Harm § 4, cmt. c (2010).  Negligence claim dismissed.

We love this decision.  In the mass torts that compose the bulk of our practice, we struggle to implement Lone Pine orders and similar measures that give us the ability to cull plaintiffs who are not “injured” from the queue of outstretched hands.  Bright lines, like those the Berry court drew, aid immeasurably in these efforts.  We will keep you posted on states that have yet to fall in line.  In the meantime, stay safe out there.