We have always wondered why judges are hesitant to sever the claims of plaintiffs who never should have joined their claims together in the first place.  You know what we mean—multiple plaintiffs, sometimes dozens of them, who join their claims together in one complaint based only on the allegation that they used the same or similar products.  This is not only about avoiding filing fees (although it partly is).  Plaintiffs and their attorneys frequently use improper joinder to manipulate the forum and evade federal jurisdiction.  That occurs when multiple plaintiffs whose claims unquestionably presented complete diversity of citizenship combine their claims into one complaint with one or more plaintiffs whose citizenship is not diverse with one defendant.

The proper approach here is to sever the separate plaintiffs’ claims so each can proceed on its own, and a recent case in California illustrates the two ways by which to do that.  In Kline v. Mentor Worldwide, LLC, No. 2:19-cv-00877, 2019 WL 3245102 (E.D. Cal. July 19, 2019), plaintiffs from California, Pennsylvania, Mississippi, and Florida sued Pennsylvania and California defendants alleging personal injuries from breast implants.  As you might expect, each plaintiff had her own story—different doctors, different alleged injuries, different procedures over extended periods of time, etc.—so the defendants removed the case to federal court.

But what about the lack of complete diversity?  The defendants urged the district court to (1) find the California defendant (a holding company that neither made nor sold a product) fraudulently joined and (2) asked the district court to sever the claims of the individual plaintiffs, who were completely unrelated.  This is the first way to address the improper joinder of unrelated plaintiffs—remove to federal court and argue “fraudulent misjoinder” (which is different from “fraudulent joinder”).  We explained fraudulent misjoinder in some detail in one or our earliest posts here, but in short it just means that the district court should sever the individual plaintiffs’ claims and retain jurisdiction over those where there is complete diversity.

That is what the district court in Kline should have done, but it only partly delivered.  To begin, the district court found that the plaintiffs had fraudulently joined the California holding company because “plaintiffs have not articulated any legal theory under which they could potentially recover against defendant [holding company].”  Id. at *4.  The California holding company’s citizenship therefore was disregarded.  Id.

The district court deferred, however, on whether to sever the plaintiffs’ claims as misjoined.  It mattered for diversity jurisdiction because there were still a Pennsylvania plaintiff and a Pennsylvania defendant left in the case.  But the district court decided that the state court on remand “could evaluate the propriety of joinder under state law.”  Id.  The district further observed that “[i]t does not appear that doing so will frustrate defendant’s statutory right of removal in the event that the state court should subsequently severe plaintiffs’ claims.”  Id.

It seems to us that remanding under these circumstances was unnecessary, especially where the district court expressly contemplated that the case might be removed again.  But the order does lead us to the second way to address the improper joinder of unrelated plaintiffs—file a motion to sever in state court.  That is what the defendants did on remand, and it worked.  Citing the binding authority of David v. Medtronic, 237 Cal. App. 4th 734 (2015) (which came in fourth on our top drug and device opinions list for 2015 and which you can read more about here and here), the state trial court ruled that plaintiffs are not properly joined where they are merely implanted with the same medical device during different surgeries performed by different surgeons who had different levels of knowledge.  Kline v. Mentor Worldwide LLC, No. 34-2019-00255852-CU-PL-GDS, Slip op. at 2 (Cal. Superior Court Nov. 13, 2019).  In so ruling, the state court cited the plaintiffs’ different residences, different procedures at different times, and their different alleged injuries.  Id.  The state court also rejected the argument that an alleged failure to follow FDA regulations and report adverse events was sufficient to support a finding that the plaintiffs’ surgeries were “part of the same series of transactions.”  Id.  Moreover, the duty to report adverse events was not the same for each plaintiff’s case anyway because of different requirements at different times.  Id.

In the end, the state court ruled as follows:

Under these circumstances, the Court finds that Plaintiffs have not alleged a single scheme, depending on the same misrepresentations, and leading to transactions exactly similar in kind and manner of operation.  [citing David v. Medtronic].  The Court finds that Plaintiffs’ separate surgeries, conducted at different times by different physicians in different states, are separate and distinct transactions.  Accordingly Plaintiffs were not properly joined under Code of Civ. Proc. § 378 and severance is proper.

Id.  This is the correct result, and we will return to our opening observation:  Why are court hesitant to enter orders like this one?  We don’t know.  We do know that the federal district court in Kline expressed its view that the defendants could remove again if the state court severed the plaintiffs’ claims, which it did.  We also know that the federal district court has already ruled that the California holding company defendant (a forum defendant) was fraudulently joined.  We like the defendants’ chances going forward.

We are rounding the final curve of the Fall academic calendar, so now come the sessions in the litigation class we teach at Penn Law when we discuss story-telling. It is not as if we have anything novel to say. The best (most attention-getting, understandable, memorable, and persuasive) stories are ones we have already heard before and already believe. Some of those stories usually work well for our side (people need to exercise personal responsibility, a deal is a deal) and some usually work against us (dollars over lives, David vs. Goliath).

It is utterly distasteful, but we feel obliged to devote time to schooling the students on the reptile mode of storytelling. Most of you have probably heard of this plaintiff ploy. It slithers along on the notion that the reptilian part of human brains is fully intact, active, and lurking under our higher paleomammalian and neomammalian brain -bits. That reptile lobe is always fretting over potential dangers to ourselves. The plaintiff lawyer reptile strategy is to make jurors worry about how the defendant’s conduct did not merely harm the plaintiff in the case, but posed a threat to the community – more pointedly, to the jurors and their loved ones. Thus, so the reptile theory goes, the jurors will feel (and it is a feeling, not a thought) that a verdict for the plaintiff, with punitive damages, is necessary for self-preservation.

There are books out there on the reptile theory. The seminal text is D.Ball & D. Kennan, Reptile: The 2009 Manual of the Plaintiff’s Revolution. Another one is C. Bettinger, Twelve Heroes, One Voice: Guiding Jurors to Courageous Verdicts. Guess what “courageous” means. These books are not made readily available to defense hacks. There are restrictions and high prices (check out eBay). But the books do not really tell you anything you haven’t heard hundreds of times. Plaintiff lawyers put the reptile theory in motion by badgering company witnesses to buying into broad “safety rules.” The next step is to show that the defendant did not satisfy those rules. The gap between the Ought and the Is gets filled with money.

We laid out the reptile theory to our students and we could tell by their facial expressions that they were skeptical. In the parlance of the times, they were unconvinced that the reptile theory really is “a thing”. To their ears, the reptile theory sounded sort of insipid. (Bright students!).

Then, as if to supply us with a convenient heuristic tool, a case came out recently demonstrating that the reptile theory is, indeed, “a thing,” that it can work, that it is improper, and that plaintiff lawyers can nevertheless get away with it. That case is Fitzpatrick v. Wendy’s Old Fashioned Hamburgers, ___ N.E.3d ___, 2019 WL 5792847 (Mass Ct. App. Nov. 7, 2019). The plaintiff bit into a fast-food hamburger and broke a molar on small bit of bone that snuck its way past the manufacturing process. That manufacturing process seems to have been as good as it can be – it sorted through the meat as carefully as possible whilst still being capable of producing hamburger meat. The manufacturers were stuck with the truest yet weakest defense: sometimes bad things happen through nobody’s fault. The case proceeded on a warranty claim. The theory of that claim is that the consumer did not reasonably expect to find an injury-causing substance in the food.

The plaintiff counsel’s closing argument exploited the reptile theory for all that it was worth. Here are the points it hit, and hit hard:

• Imagine the plaintiff’s surprise when she bit into the hamburger thinking it was safe, only to discover bone in it. “See what (the plaintiff) did not know, and what [defendants] did know, is that bone can get into the final burger. They have insider knowledge…. I asked Wendy’s do you tell your customers? No. How are people supposed to know if they’re not told? They don’t have the insider knowledge.”
• “[W]e all use thousands of things and we all eat thousands of foods, and companies manufacture thousands of products. Things that only hurt people once in a while. Maybe something hasn’t hurt somebody yet. But when a product hurts somebody, the company always says, oh, that never happened before. The safety rules says that the company must make safe food. And the law says that if they did not make safe food and you reasonably expect it, we reasonably expect it to be safe, they’re responsible. Because if you add up all the people that are hurt by things that hardly ever hurt anyone, that adds up to a lot of dangerous things. And sooner or later a danger is going to claim a victim. That’s why the law does not care how many times it happened before. The law asked was the bone there and should we have reasonably expected it to be there. That’s the law. Not how many times it happened.”
• “Sixty million burgers, I don’t know if that’s true or not. But there’s no – – I don’t know if there’s any evidence of that before you. [Defendants’ counsel] said it. That’s fine. But you know what, when [defendants] sell all those burgers, they are more than happy to take our money. We pay for the burger. It goes to them. But when a burger hurts somebody, no responsibility. No accountability. Shame on them, honestly – shame on them.”
• “Are these important rules in our community? Are we going to enforce them? Are you going to enforce them? If the rules that we talked about here, the safety rules, if those are important you need to speak to that. You[r] verdict will speak volume echoing outside this Courthouse. If the rules are not important. If it’s okay for them to serve burgers with bone and someone gets hurt once in a while, and if they get injured, too bad for them. Then you know what? Give these guys a pass. Give them a pass. I don’t think you can. I don’t think you can give them a pass. I don’t think you can say it’s okay to have a burger with bone in it or had gristle and sell burgers. If you say that their conduct is okay then you’re essentially rewarding their conduct by giving them a pass.”
• “And I think I speak for everyone here, what we want from your verdict is that when you leave this courthouse later today with you head held high, proud of what you did, you gave up time from work and from family, and I want you to know that it mattered. It was important. And you should be comfortable with – with what happened here. And this may be the kind of case that triggers something for you a month from now or a year from now. You might be eating a burger. Maybe you’ll read an article that someone else got hurt by a food product. Or you’ll be telling your wife of your husband about the case. That somebody ate a burger and they did not expect to get hurt. And that safety rules were violated and that you helped to make a wrong right. You made it right and you held them responsible and accountable.”

Defense counsel did not lodge objections to any specific components of plaintiff counsel’s closing, nor did he move to strike any of the statements made.

The jury returned a verdict in favor of the plaintiff in the amount of $150,005.64. The defense moved for a mistrial on the basis of the improper closing argument. The trial court granted the motion, the case was retried, and the second jury returned a verdict in favor of the plaintiff in the amount of $10,000. On appeal, the plaintiff argued that the mistrial was improper. The issue boiled down to the propriety of the plaintiff’s closing argument.

Now we get the classic good news/bad news situation. The good news is that the Fitzgerald court held that the plaintiff’s closing argument was improper: “Certain types of argument are improper. To appeal to the juror’s emotions, passions, prejudices, or sympathies; to ask the jurors to put themselves in the position of any person involved in the case.” More specifically, the plaintiff counsel’s repeated references to “we” and “us” “impermissibly integrated the jurors with the plaintiff (and counsel) within a community of the “average customers.” There is nothing wrong with asking jurors to employ “their common sense and life experience to determine the reasonable expectations of a consumer. He could also permissibly argue that the plaintiff was an average consumer. But what he could not do was to draw the jurors into the position of the plaintiff.” It gets better: “Nor was counsel permitted to invoke future possibilities of harm, or that the jury through their verdict could protect the community from such dangers, or that a defendants’ verdict would give the defendants a ‘pass’ or ‘reward’ them.”

Finally (but not really, as we will see in a moment), the court saw “no justification for the final portion of the plaintiff’s counsel’s argument, which attempted to draw the jury into imagining a hypothetical future moment when they might think about their jury service and remember that “safety rules were violated and that you helped to make a wrong right. You made it right and you held them responsible and accountable.” Thus, the appellate court, just like the trial court, concluded “that portions of the plaintiff’s counsel’s closing were outside the bounds of permissible argument.”

But then there’s the bad news, at least for the defendants. The appellate court held that the trial court decided the mistrial motion by focusing exclusively on the propriety of the closing argument, when it should have surveyed the “whole case.” The appellate court emphasized that much of the evidence in the case was uncontested, including the cause and extent of injury. The reasonableness of the defendants’ actions was not at issue, because it was a warranty, not a negligence, case. Plus, the trial judge had issued curative instructions and the jury took a long time to deliberate. The appellate court believed that the $150K was not out of bounds considering the injury at issue. The appellate court ended up remanding the case to the trial judge to reconsider its ruling under “the correct standard” of measuring the bad closing argument against the whole case.

To our mind, the appellate court overthought things. It chewed more than it bit off (that’s an old joke about the writer Henry James, but we couldn’t resist). The plaintiff’s closing argument pushed every reptile button possible, and rung the bell 15 times louder than it did when the reptile was kept out of the courtroom. We hope the trial court considers that simple fact when it mulls over the “whole case.”

Fitzgerald is not drug/device litigation, but this case is significant as the first appellate case we know of that has specifically addressed and declared certain “reptile” trial tactics improper. With the increasing prevalence of such tactics, that is an important holding, even if in this particular case the trial court’s new trial order was vacated because of squirrelly procedural issues. Those procedural issues can be fixed in other cases, and maybe even in this one. But at least we can now point to clear authority that reptile arguments should be extinct in the courtroom.

Sort of like hail in Alabama.  It happens, but when it does it’s an event.  Not like say picking a perfect NCAA March Madness bracket (1 in 2.4 trillion).  Maybe more like the chance of getting struck by lightning in a lifetime (1 in 13,000).  In any case, a California trial court decision finding no warning causation under the learned intermediary doctrine caught our attention as newsworthy.  The case is one of the coordinated Pradaxa Cases, Case No. CJC-16-004863 (Cal. Super. Nov. 8, 2019) (Lawson, CGC-17-559611), slip op.

Plaintiff was prescribed Pradaxa in late 2010 to treat her atrial fibrillation.  Id. at 2-3.  Her prescribing physician testified that at the time he prescribed Pradaxa to plaintiff he was aware that it carried a risk of significant bleeding, which risk was increased in female patients over the age of 75, which plaintiff was.  Id.  The prescriber also testified that he informed plaintiff of these risks.  In 2016, plaintiff suffered an intracranial hemorrhage.  She was administered the Pradaxa reversal agent and was stabilized.  Id. at 4.    Defendant moved for summary judgment on plaintiff’s claims for failure to warn, fraud, and misrepresentation.

We’ve seen these cases elsewhere before – no warning causation where doctor knew of the very risk (and in this case warned of the risk) that materialized.  But, again this is California.  The court pointed out that neither party cited any California cases to support their arguments on warning causation.  There was no binding precedent.  Id. at 8n.9.  What the court did find persuasive in this instance is the level of speculation needed on all sides to find causation – a level to which the court was unwilling to go.

First, plaintiff could not testify that she definitely would have changed her mind if provided additional risk information.  At best she said she “probably” would have refused or “might” have said no.  That’s not enough.  Id. at 4n.5.

Second, the prescribing physician, after being shown “various medical literature, references to [manufacturer] company documents, and regulatory documents,” testified that he stood by his prescribing decision.  The additional information would not have changed either his decision to prescribe Pradaxa to plaintiff or his informed consent discussion.  Id. at 5.  “This evidence is sufficient to demonstrate that Defendant’s alleged failure to warn did not proximately cause Plaintiff’s injury.”  Id. at 9.

What plaintiff clung to was her physician’s testimony that he would have liked to have known if there was a mechanism to monitor/measure a patient’s Pradaxa levels and that he would have measured the levels to see if there was a risk of a major bleed.  Id. at 5.  Plaintiff used this testimony to attempt a factual leap of causation.  If the doctor had known he could measure Pradaxa levels, he would have.  And if he did, he would have discovered her elevated levels and reduced her Pradaxa dosage or changed her medication to a different anticoagulant.  Id. at 9.  But the prescriber’s testimony only supports that he would have measured plaintiff’s levels, not whether those measurements would have caused him to alter courses.  In other words, [p]laintiff’s theory for proximate causation is speculative.”  Id.

The speculation could not be saved by a retained expert’s opinion.  Plaintiff’s expert testified that the elevated levels of Pradaxa in plaintiff’s blood “more likely than not caused her intracranial bleed.”  Id. at 11.  But warning causation is about the learned intermediary, not an outside expert:

However, regardless of [plaintiff’s expert’s] opinions, what matters to the causation inquiry in this case is [the prescriber’s] opinion, that is, as the learned intermediary, whether [the prescriber] would have changed his course of treatment or provided different warnings to Plaintiff.

Id. That evidence simply did not exist and that “absence of evidence” was fatal to plaintiff’s case.  Id. at 12.

Plaintiff’s last effort to save her case was to argue that because her prescribing physician testified that he may have changed some of his conduct if provided different information she had met her burden of proof.  But plaintiff did not frame the legal question correctly.

Upon a review of the case, the legal inquiry on causation is not, as Plaintiff suggests, whether the prescribing physician would have changed his conduct of the manner in which his [sic] would have prescribed the drug if he had received the warning or risk information of which he was unaware at the time.  Such a standard is too broad.  Rather, the change in a physician’s conduct or prescription procedures must have sufficiently prevented the Plaintiff’s injury, and/or be sufficiently connected to the injury.

Id. at 14 (citations and quotation marks omitted).  In other words, to defeat summary judgment, any change in the prescribing physician’s conduct must have been causally related to the alleged injury.  All doctor’s want to know more.  That is not enough to create a triable issue of fact.  Id. at 15-16.  Doctors get new information all the time that has no impact on their prescribing decisions.  To establish causation, the doctor must testify that he would have wanted to know and he would have done something differently that is related to the actual injury plaintiff suffered.  A possibility of a change in conduct is likewise insufficient – “might” or “may” are not enough.  Id.

The lack of warning causation was fatal to all of plaintiff’s warning-based claims and summary judgment was granted.  This might not be a blue moon (1 every 2.7 years) or a shark attack on a human (1 in 3.7 million).  It may not even be the only favorable California trial court decision we blog about this week.  But just because you find more than one four leaf clover in the same field doesn’t make it any less remarkable.  Who knows when the next one will come along?

Manufacturers supervising medical doctors?  In two words, they don’t.  Yet plaintiffs, particularly in cases where preemption forecloses more normal product liability claims, try to get courts to impose such duties.  We took a look at that issue back during the early days of the blog, when it was still a Bexis/Herrmann operation, in our September 17, 2009 post entitled “Limits to Duty.”  It’s been ten years, so we thought that post deserved an update.

We’ll leave the older cases alone, since they were thoroughly discussed back in 2009, except to relist them:

Appellate decisions holding no duty by sales reps (or manufacturers generally) to supervise doctors:

E.R. Squibb & Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997) (no duty to ensure doctor warned patient); King v. Searle Pharmaceuticals, Inc., 832 P.2d 858, 866 (Utah 1992) (no control over doctor’s technique); Pfizer, Inc. v. Jones, 272 S.E.2d 43, 45 (Va. 1980) (no nitpicky instructions); Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1283 (11th Cir. 2002) (no duty to warn a patient’s relatives); Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 975-76 (10th Cir. 2001) (no nitpicky instructions) (applying Kansas law); Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1233 (10th Cir. 2001) (no duty to enforce product storage warning) (applying Kansas law); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1193 (11th Cir. 1995) (no duty to provide more-than-adequate warning) (applying Florida law); Plummer v. Lederle Laboratories, 819 F.2d 349, 357-58 (2d Cir. 1987) (no nitpicky instructions) (applying California and New York law); Swayze v. McNeil Laboratories, Inc., 807 F.2d 464, 468, 472-72 (5th Cir. 1987) (no duty to supervise administration of anesthesia) (applying Mississippi law); Kennedy v. Medtronic, Inc., 851 N.E.2d 778, 785-87 (Ill. App. 2006) (no duty to prevent off-label use); Banner v. Hoffmann-La Roche, Inc., 891 A.2d 1229, 1241 (N.J. Super. A.D. 2006) (no duty to withhold prescribed medication); Kennedy v. Merck & Co., 2003 WL 21658613, at *5 (Ohio App. July 3, 2003) (no duty to ensure doctor warned patient); Brown v. Glaxo, Inc., 790 So.2d 35, 39-40 (La. App. 2000) (no duty to provide more-than-adequate warning); Pluto v. Searle Laboratories, 690 N.E.2d 619, 622 (Ill. App. 1997) (no duty to provide more-than-adequate warning); Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996) (no duty to provide more-than-adequate warning); Disbrow v. Richards, Inc., 1996 WL 593780, at *2 (Tex. App. Oct. 17, 1996) (organizing instruments not unauthorized practice of medicine); .Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 819 (Cal. App. 1992) (no nitpicky instructions); Nichols v. Clare Community Hospital, 476 N.W.2d 493, 495 (Mich. App. 1991) (no nitpicky instructions); Dunn v. Lederle Laboratories, 328 N.W.2d 576, 581 (Mich. App. 1982) (no nitpicky instructions); Buckner v. Allergan Pharmaceuticals, 400 So. 2d 820, 822-24 (Fla. App. 1981) (no duty to ensure doctor warned patient); May v. Dafoe, 611 P.2d 1275, 1277-78 (Wash. App. 1980) (no duty to provide basic information).

Trial court decisions holding no duty by sales reps (or manufacturers generally) to supervise doctors:

Harrington v. Biomet, Inc., 2008 WL 2329132, at *7 (W.D. Okla. June 3, 2008) (no duty to advise surgeon about component size); Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1370 (S.D. Fla. 2007) (no duty to ensure doctor warned patient); Ames v. Apothecon, Inc., 431 F. Supp.2d 566, 573 (D. Md. 2006) (no nitpicky instructions); Stafford v. Wyeth, 411 F. Supp.2d 1318, 1321 (W.D. Okla. 2006) (no duty to ensure doctor warned patient); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 921 (S.D. Tex. 2005) (no duty to provide more-than-adequate warning); Evans v. Medtronic, Inc., 2005 WL 3547240, at *15-16 (W.D. Va. Dec. 27, 2005) (no duty to obtain and preserve explanted device); Taylor v. Pharmacia-Upjohn Co., LLC, 2005 WL 3502052, at *4 (S.D. Miss. Dec. 19, 2005) (no duty to ensure doctor warned patient); Lemon v. Anonymous Physician, 2005 WL 2218359 (S.D. Ind. Sept. 12, 2005) (no duty to assist doctors); Billone v. Sulzer Orthopedics, Inc., 2005 WL 2044554, at *5 (W.D.N.Y. Aug. 25, 2005) (no nitpicky instructions); In re Meridia Products Liability Litigation, 328 F. Supp.2d 791, 814 (N.D. Ohio 2004) (no duty to provide basic information), aff’d, 447 F.3d 861 (6th Cir. 2006); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 439-40 (E.D. Pa. 2004) (no duty to prevent off-label use); Harris v. Purdue Pharma, L.P., 218 F.R.D. 590, 596-97 (S.D. Ohio 2003) (no duty to prevent off-label use); Labzda v. Purdue Pharma, L.P., 292 F. Supp.2d 1346, 1355 (S.D. Fla. 2003) (no duty to control doctors’ prescribing habits); Kernke v. Menninger Clinic, Inc., 173 F. Supp.2d 1117, 1122 (D. Kan. 2001) (no duty to supervise informed consent); Prohaska v. Sofamor, S.N.C., 138 F. Supp.2d 422, 444 (W.D.N.Y. 2001) (no duty to ensure doctor warned patient); Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000) (no duty to prevent off-label use); Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *8-9 (S.D. Cal. Mar. 29, 2000) (no duty to prevent off-label use); Lawrence v. Sofamor, S.N.C., 1999 WL 592689, at *4 (N.D.N.Y. Aug. 2, 1999) (no duty to provide basic information); Krasnopolsky v. Warner-Lambert Co., 799 F. Supp. 1342, 1346 (E.D.N.Y. 1992) (no duty to ensure doctor warned patient); Hunt v. Hoffmann-La Roche, Inc., 785 F. Supp. 547, 550 (D. Md. 1992) (no duty to ensure doctor warned patient or to require mandatory medical tests); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1033 (D.N.J. 1988) (no duty to tell doctors how to practice medicine or to ensure they warned patients); Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569, at *7 (Mass. Super. Sept. 24, 2004) (not guarantor of doctor competence).

Since 2009, plaintiffs have unsuccessfully attempted to impose upon manufacturers a general “duty to train” (non-employee) doctors in the use of their products.  We’ve discussed that type of claim here and addressed it as a prohibited “educational malpractice” claim here.  In the absence of:  (1) an employment relationship. (2) a voluntary undertaking, or (3) an FDA-imposed duty, to provide training (and even these must be properly pleaded, e.g., McLaughlin v. Bayer Corp., 172 F. Supp.3d 804, 817 (E.D. Pa. 2016)), these claims have been unsuccessful.

In general, there is no duty to take affirmative action to assist or protect another.  As the jury was instructed here, [defendant] had no duty to train physicians on the use of its . . . products.

Scott v. C.R. Bard, Inc., 180 Cal. Rptr. 3d 479, 490 (Cal. App. 2014).  See Glennen v. Allergan, Inc., 202 Cal. Rptr.3d 68, 83-84 (Cal. App. 2016) (“The manufacturer of a prescription medical device has no duty to train a physician in using its medical device” because “manufacturers are not responsible for the practice of medicine”).

[Plaintiffs] attempt to circumvent the learned intermediary doctrine by characterizing the issue as one of training rather than of warning . . . .    [T]his is a distinction without a difference. . . .  Thus, [defendant] satisfied its duty . . . by providing clear, unambiguous information concerning the contraindications for [the product], as well as the risks associated with it.  Whether [defendant] was “training” or “warning” [the treater] of these risks when it provided him the package insert is, as the district court recognized, an issue of semantics only.  As a matter of law [defendant] discharged its duty to advise [the treater] of the risks associated with [the product] by providing clear, unambiguous information about these risks in the . . . package insert.  [The treater] then owed a duty to [plaintiff] to read the package insert and exercise judgment in discussing those risks with [her] and in using the [the] product to treat [her].

Rounds v. Genzyme Corp., 440 F. Appx. 753, 756 (11th Cir. 2011) (applying Florida law).  Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), adopted Rounds’ non-precedential ruling.  “Florida law does not allow the improper training theory to proceed . . . [because] the learned-intermediary doctrine bars this theory of negligence.”  Id. at 1329 (affirming on the basis of Rounds).

Thus, an allegation that defendant “failed to train, warn or educate” physicians fails “to state a claim to relief that is plausible on its face”.  Woodhouse v. Sanofi-Aventis U.S. LLC, 2011 WL 3666595, at *3 (W.D. Tex. June 23, 2011).  See Richardson v. Bayer Healthcare Pharmaceuticals, Inc., 2016 WL 4546369, at *6 (D. Idaho Aug. 30, 2016) (finding no “relevant law . . . demonstrat[ing] that a manufacturer owes a duty under Idaho law to train physicians”); Williams v. Smith & Nephew, Inc., 123 F. Supp.3d 733, 747 (D. Md. 2015) (plaintiffs failed to establish that failure to train was “actionable under state law”); Sanchez v. Boston Scientific Corp., 2015 WL 631289, at *6 (S.D.W. Va. Feb. 12, 2015) (“West Virginia does not recognize a duty to provide training to physicians”); Wise v. C.R. Bard, Inc., 2015 WL 541933, at *8 (S.D.W. Va. Feb. 10, 2015) (“Texas does not recognize a duty to provide training to physicians”) (applying Texas law); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 WL 505234, at *5 (S.D.W. Va. Feb. 5, 2014) (“Texas cases recognize the duty of drug and medical device manufacturers to warn physicians, not to provide training to them.”) (applying Texas law).  See also Glorvigen v. Cirrus Design Corp., 816 N.W.2d 572, 583 (Minn. 2012) (refusing to create generalized duty to train outside prescription medical product context); McKesson Medication Management, LLC v. Slavin, 75 So.3d 308, 314 (Fla. App. 2011) (no legal basis for failure to train claim against pharmaceutical services provider); In re Dicamba Herbicides Litigation, 359 F. Supp.3d 711, 739 (E.D. Mo. 2019) (“negligent training claims generally are not recognized outside the employer/employee context”).

The aforementioned Swayze decision supported rejection of failure to train and supervise surgeons in Sons v. Medtronic, Inc., 915 F. Supp. 2d 776 (W.D. La. 2013).  “[E]ven assuming arguendo that plaintiff’s failure to train/instruct claims are not preempted. . . .  It is well established that a medical device manufacturer is not responsible for the practice of medicine.”  Id. at 783.  In addition to Swayze, Sons cited this little Louisiana gem:

[The sales representative’s] purported statements addressed what type of spinal procedure [the surgeon] should perform on [plaintiff].  As a seasoned neurosurgeon, it is patently unreasonable for [him] to rely on a sales representative’s opinion about the type of procedure that should be employed in operating on a patient’s spine. . . .  Because [the surgeon’s] reliance was unreasonable as a matter of law, the negligent misrepresentation claim against him must fail.

Hall v. Horn Medical, L.L.C., 2012 WL 1752546, at *3 (E.D. La. May 16, 2012) (citation and footnote omitted).

A similar purported duty – not designated as involving “training,” was likewise rejected in McCartney v. United States, 31 F. Supp.3d 1340 (D. Utah 2014).  No duty exists “to ensure that the physician properly implanted the . . . device.”  Id. at 1345.

This cause of action is one for [defendant’s] nonfeasance during [plaintiff’s] surgery. . . .  [T]here is no special legal relationship between medical device manufacturers and patients such that medical device manufacturers owe a duty of care for their nonfeasance during a physician’s surgery.  [Defendant] did not owe Plaintiff a duty to ensure the physician properly implanted the medical device at issue.

Id.

“There is a relatively new, yet now common practice, of having medical device company representatives attend surgeries.”  McCartney, 31 F. Supp.3d at 1343.  Because sales representatives perform many services not regulated by the FDA, plaintiffs facing strong preemption arguments often try to scapegoat sales representatives.  We’ve discussed this situation before as well.  Here are relevant post-2009 cases.  In Wolicki-Gables v. Arrow International, Inc., 641 F. Supp.2d 1270 (M.D. Fla. 2009), aff’d on other grounds, 634 F.3d 1296 (11th Cir. 2011), the mere presence of a sales representative in the operating room did not create any duty:

Even if the finder of fact infers that [defendant’s sales representative] did have some interaction with [the surgeon] during that surgery, the Court does not know of any evidence that establishes that [the sales representative] had a duty to affirmatively tell [the surgeon], while [he] was performing surgery, that [the surgeon] should not [do what the surgeon did concerning the defendant’s device].

Id. at 1291.  “[The surgeon] testified that the decisions made while he performed surgery were his own decisions.”  Id.  Thus, beyond the usual product warnings, there was no “duty to use reasonable care in the instruction and education of physicians.”  Id. at 1279.  See Suckow v. Medtronic, Inc., 971 F. Supp.2d 1042, 1047-48 (D. Nev. 2013) (sales representative “interrogating” medical device created no duty where, “it is the physician who interprets any data and makes decisions”); Millman v. Biomet Orthopedics, Inc., 2013 WL 6498394, at *5 (N.D. Ind. Dec. 10, 2013) (that sales representative “remain[ed] in the operating room throughout the procedure” as an “observer” did not, without more, create any duty); Patterson v. DePuy Orthopaedics, Inc., 2011 WL 3047794, at *4 (N.D. Ohio July 25, 2011) (“there is no duty owed between a sales representative and a patient”).

In Smith v. St. Jude Medical, Inc., 158 Cal. Rptr. 3d 302 (Cal. App. 2013), the plaintiff claimed that the surgeon acted “[u]nder the guidance and direction of” the defendant’s sales representative.  Id. at 305.  Summary judgment was granted and affirmed because that allegation was baseless.  The “sales representative . . . did not instruct or direct [the surgeon] on how or where to implant the [device].”  Id. at 309.  Rather, “doctors choose to do whatever they need to do” and “the doctor, not [the sales representative], determines where to place the [device].”  Id.  The court also relied on Kennedy v. Medtronic, supra, finding it to be “consistent with California law.”  Id. at 310.

Similarly, in O’Connell v. Biomet, Inc., 250 P.3d 1278 (Colo. App. 2010), the court invoked the “captain of the ship doctrine,” to affirm dismissal of negligence claims against a sales representative.  Id. at 1283.  “[T]he cases have not limited the doctrine only to hospital employees.”  Id.  Thus, a sales representative in the operating room is subject to the ultimate “control” of the surgeon – not vice versa:

The sole purpose of [the sales representative] being in the operating room was to provide [the surgeon] with information about the [device], which information [the surgeon] then used to make his medical judgments.  That is, [the surgeon] remained in control of the surgery vis-à-vis [the sales representative] and all other non-physicians in the operating room.  Because [the surgeon] remained in control of the surgery, anything [the sales representative] might have done during that surgery, including any advice he allegedly gave or should have given to [the surgeon], was done as a crew member, so to speak, of the surgical ship.

Id. at 1283-84 (adopting trial court opinion).  Thus surgeons “ha[ve] the right to control and supervise” manufacturer’s sales representatives when such representatives are in the operating room.  Id. at 1284.

In Small v. Amgen, Inc., 134 F. Supp.3d 1358 (M.D. Fla. 2015), aff’d, 723 F. Appx. 722 (11th Cir. 2018), the plaintiff “argu[ed] that [the prescriber] cannot be treated as a learned intermediary because defendants’ pharmaceutical sales representative advised” him.  That advice, however, was “irrelevant” because “the prescribing physician had independent knowledge of the risk.”  Id. at 1372.  Sales representatives are under no duty to provide “guidance” to physicians:

The problem with this theory is that manufacturers are only required to warn the prescribing physician of the possibility that the drug may cause the injury alleged by the plaintiff.  There is no duty to provide guidance under Florida law.

Id. (citation omitted).

The plaintiff in Greenwood v. Tehrani, 2017 WL 4083099 (N.Y. Sup. Sept. 15, 2017), alleged that the defendant’s sales representative “fail[ed] to ensure that [plaintiff’s] physician used the device in ‘a safe, indicated manner,’” that is, failed to prevent off-label use.  Id. at *3.  That claim was pitched.  “[W]hile the manufacturer of a medical device has a duty to warn a patient’s physician of the risks associated with the device, the manufacturer is not responsible for how the physician uses the device and renders the medical care.”  Id. (citing Prohaska and Lawrence, cited above).

Instead of manufacturers (or their sales representatives) supervising the medical community, the law has long taken the opposite position.  After providing an adequate warning, a manufacturer “may reasonably assume that the physician will exercise his informed judgment in the patient’s best interests.”  Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875, 878-879 (Ohio 1991).  Once giving sufficient warning, “the manufacturer may reasonably assume that the physician will exercise the informed judgment . . . in the best interest of the patient.”  McKee v. American Home Products Corp., 782 P.2d 1045, 1050 (Wash. 1989) (citation and quotation marks omitted).  “[T]he drug manufacturer could not be penalized for the failure of the doctor to impart knowledge concerning the dangers of the drug of which the doctor had been warned.”  Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 105 (Fla. 1989).  The “failure [of the learned intermediaries] to perform their duties from that point forward do not operate to create, or to extend, a manufacturer’s duty to warn . . . any persons other than the learned intermediary.”  Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1283 (11th Cir. 2002) (applying Georgia law).

How the physician communicates the medicine’s dangers to the patient is the physician’s own decision, and his or her independent duty.  There is no legal support for imposing upon a drug manufacturer an “advisory” role in that decision.  Education of the physician, on the one hand, and communication to the patient, on the other, are distinct processes, and the manufacturer’s duty involves only the former.

Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 421 (D. Alaska 1987).

There are many such cases, and they are collected in Bexis’ Book, §2.03[1] at footnotes 45-46.  Updating the 2009 post, the “law does not require that the drug manufacturer provide such detailed information or instructions so as to remove the medical judgment of the physicians.”  Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 6230489, at *7 (M.D. Pa. Dec. 2, 2013).  The New Jersey Appellate Division reiterated that, after providing adequate warning, a manufacturer “has no duty to ensure that the warning reaches the patient.”  Gaghan v. Hoffman-La Roche Inc., 2014 WL 3798338, at *12 (N.J. Super. App. Div. Aug. 4, 2014).  Thus:

[in] these (and prior) proceedings Plaintiffs’ counsel have done their very best to conflate the [learned intermediary rule] with the informed consent doctrine.  That’s simply not the law.  When a prescribing physician comprehends the fact that a given medicine is associated with certain potential risks, and exercises his/her medical judgment in deciding whether and how to address those risks with his/her patient, the manufacturer cannot be held responsible for the prescriber’s decision.

In re Accutane Litigation, 2016 WL 5958375, at *5 (N.J. Super. Law Div. Oct. 12, 2016).

In Chao v. Smith & Nephew, Inc., 2013 WL 6157587 (S.D. Cal. Oct. 22, 2013), plaintiff argued that the defendant had a duty to veto a physician’s patient selection where the product was contraindicated.  Id. at *4.  However, “it is the surgeon, not the device manufacturer, who makes the final determination regarding patient selection.”  Id.

Plaintiffs have cited no legal authority nor FDA regulation for the proposition that a device manufacturer owes a duty, beyond providing a warning, to dissuade a physician from using a device on a particular patient. . . .  The evidence before the court shows that Defendant . . . provided adequate warning to [the implanting surgeon] . . . and that [he] decided to proceed anyway.  The Court declines to impose an additional duty on a device manufacturer to second guess a practicing physician when that physician has already received the FDA mandated warnings.

Id. at *4-5.  See Taylor v. Intuitive Surgical, Inc., 389 P.3d 517, 525 (Wash. 2017) (quoting above language in McKee); Falsberg v. GlaxoSmithKline, PLC, 2013 WL 4822205, at *3 (Wash. App. Sept. 9, 2013) (no duty “to include diagnostic tips, or otherwise instruct a physician on how to practice medicine”); Tortorelli v. Mercy Health Center, Inc., 242 P.3d 549, 560 (Okla. App. 2010) (defendant’s “duty as a manufacturer under [the learned intermediary rule] was not to provide an in-depth education to trained physicians in the underlying biochemistry . . . but to identify and warn of risks”); Olmo v. Davol, Inc., 2017 WL 1367231, at *5 (S.D. Fla. April 7, 2017) (quoting Farnes, supra); Vakil v. Merck & Co., 2016 WL 7175638, at *7 (D.N.J. Dec. 7, 2016) (“that [the prescriber] had not read [the] label in a number of years and did not explain its risks to Plaintiff is irrelevant”) (applying Virginia law); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *7 (N.D. Ala. Oct. 31, 2013) (“plaintiffs cannot seek damages from these defendants [manufacturers/sellers] based on decedent’s treating physician’s choice of prescriptions”); Calisi v Abbott Laboratories, 2013 WL 5441355, at *17 (D. Mass. Sept. 27, 2013) (“what the prescribing physician did or did not do in response to warnings does not answer the initial issue of whether the warnings given were adequate.); In re Vioxx Products Liability Litigation, 2015 WL 1909859, at *10 (E.D. La. April 21, 2015) (if the warning is adequate, it is “no consequence whether the doctor relayed these warnings to the patient”) (applying Missouri law); In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333, 1340 (N.D. Ala. 2012) (“the decision as to use a medication as a first-line treatment is uniquely up to the prescribing medical professional”); Metz v. Wyeth LLC, 872 F. Supp.2d 1335, 1344-45 (M.D. Fla. 2012) (quoting Farnes, supra; no duty to ensure doctor warned patient), aff’d, 525 F. Appx. 893 (11th Cir. 2013); Donovan v. Centerpulse Spine-Tech Inc., 2010 WL 1269751, at *8 (W.D.N.Y. March 31, 2010) (“Nor is a manufacturer responsible for how a learned intermediary conducts his business.”), aff’d, 416 F. Appx. 104 (2d Cir. 2011); Mohr v. Targeted Genetics, Inc., 690 F. Supp.2d 711, 719 (C.D. Ill. 2010) (“Assuming the warnings were adequate, however, [defendant] would not be responsible for the physician’s failure to communicate them to the patient.”); Aaron v. Wyeth, 2010 WL 653984, at *10 (W.D. Pa. Feb. 19, 2010) (a prescriber’s “alleged incorrect belief” about what the warnings stated “is of no moment”); Cruz v. Mylan, Inc., 2010 WL 598688, at *3 (M.D. Fla. Feb. 17, 2010) (“the pharmaceutical company’s duty to warn stops at the physician”); Hildebrandt v. Johnson & Johnson, 2009 WL 3349913, at *5 (S.D. Ill. Oct. 19, 2009) (“where the facts of a case show that the manufacturer of a prescription medication gave adequate warning . . ., this operates to discharge the liability of everyone in the drug’s chain of distribution except the physician”).

Based on the foregoing, it seems that attempts to create tort duties that would require manufacturers or their sales representatives to assume supervisory responsibility for physician practice of medicine have been no more successful since 2009 than they were before.  Unless the FDA requires some specific form of physician training with a product, or the manufacturer (or its representative) voluntarily undertakes such supervision, this sort of claim remains in the realm of liability overstretch.

We write today fresh from a short cruise to celebrate a milestone birthday of the Drug and Device Law Dowager Countess. We view cruising, and the limitations of its inevitable confinement, as the perfect antidote to the often-unrelieved breakneck pace of our daily lives.   And this cruise was no exception. We eschewed shore excursions in favor of endless trivia contests, raucous piano bar sing-alongs, and sitting on our balcony with a book. Nevertheless, rough seas, and sequelae on which we will not elaborate, provoke a first-time-ever equivocal response to “how was the trip?”

We are also ambivalent about today’s case, but only a tiny bit.   In Desranleau v. Hyland’s, Inc., 2019 WL 5304860., –_ P.3d — (Wash. Ct. App. Oct. 21, 2019) the plaintiff claimed that her infant son died after ingesting the defendant’s homeopathic cold remedy, which, she alleged, contained toxic levels of certain chemical components.   (As an aside, we were surprised to see a “toxic concentration” claim in the context of a homeopathic preparation, because active ingredients in such products are generally diluted to the point of non-existence. You can read another post about homeopathic products here.)  The decedent was found dead in his bed after a couple of days of suffering from a cold. His caregiver reported that she had given him a dose of the defendant’s infant cold remedy the night before and had given him several other doses during the time that he displayed cold symptoms. An autopsy failed to reveal the cause of the infant’s death, which was therefore deemed a “sudden unexpected infant death.”

Two years earlier, as the court explained, the FDA had informed the defendant that it was concerned about the process by which the defendant manufactured a category of its products (not the cold medication), because the process by which products’ ingredients were diluted to the correct concentration could lead to so called “batch stratification;” in other words, parts of a batch could have significantly higher concentrations of a given ingredient than those contained in other parts of the batch.   Though the FDA had not raised concerns related specifically to the cold medication, the medication was manufactured through a process that was substantially similar to the manufacturing process for the implicated product.  Three years after her son’s death, and five years after the FDA’s inquiry, the plaintiff sued the defendant, alleging that an alkaloid in the cold medication killed the infant because batch stratification caused it to be concentrated at a toxic level in the batch of medication the child ingested.   The defendant moved for summary judgment, arguing that the plaintiff had no admissible evidence that the decedent had ingested the defendant’s cold medication, and the trial court granted the motion.  On appeal, the Court of Appeals affirmed the trial court’s ruling that the caregiver’s account of the medication she had given to the decedent was hearsay, not saved by any exception to the hearsay rule. But, the court held, “[E]ven though the trial court correctly identified [the caregiver’s] testimony as hearsay, [it] did not provide [the plaintiff] with the benefit of all reasonable inferences.” Desranleau, 2019 Wl 5304860 at *4.   The court reversed the trial court’s decision, holding that, because it was undisputed that the baby had had a cold for a few days before he died, and because an open bottle of the defendant’s product was found in the home in a different location from products prescribed for other members of the household, “there was enough circumstantial evidence, viewed in the light most favorable to [the plaintiff], for a jury to find that [the infant] ingested [the defendant’s] cold medicine.” Id. at *5.

We have sympathy, of course, because we understand the proof problem and because the decedent was a baby.  But mostly we are unhappy about the prospect of “product identification” being deemed adequate in other cases in the absence of toxicological (or any) evidence, simply because the product — among numerous other products — was on the scene.   We fear a slippery slope that muddies the burden of proving the most basic element of any product liability suit: the plaintiff’s use of the defendant’s product. And we wonder how far “permissible inferences” can go.   We will watch for decisions on similar facts, and we will keep you posted.

More than ten years since the Supreme Court wrote Twombly and Iqbal, the power of those two decisions remains strong enough to roll over almost any claims that dare to show up without supporting facts. The plaintiff in Shapiro v. NuVasive, Inc., 2019 U.S. Dist. LEXIS 191373, at *4-5 (S.D. Fla. Nov. 5, 2019), directed design and manufacturing defect claims at the manufacturer of pedicle screws that had broken off and caused her pain seven years after her spinal surgery.  The plaintiff made no allegations, however, about the actual defect. Defendant moved to dismiss.

Can you see TwIqbal rolling over the horizon?

The court started off, as most federal courts do, by grounding its analysis in TwIqbal. Id. at *3. It explained that a plaintiff must allege “enough facts to state a claim to relief that is plausible on its face,” pointing directly to Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). Facts that “do not permit the court to infer more than the mere possibility of misconduct” are insufficient, with the court pointing this time to Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009).

Can you hear TwIqbal rumbling louder?

The court then took the plaintiff to task for relying solely on the allegation that the screw broke off seven years after the surgery. The court explained that the plaintiff must at least identify the defect, even though she needn’t prove it yet:

[Plaintiff] argues, without citing a strict liability case, that this allegation is sufficient, and that requiring her to specify how the product is defective is “unattainable” and that it is “contrary to law” to require a plaintiff to definitively prove her claims at this stage. However, the law only requires Shapiro to identify a defect that she contends caused her injury. It does not require Shapiro to prove that the screws used in her surgery were in fact defective.

Id. at *5 (emphasis added).

It’s a roar now.

The court ended by addressing plaintiff’s failure to test, failure to inspect and failure to warn claims. In Florida, failure to test and failure to inspect are not independent claims. They are subsets of plaintiff’s defect claims, which the court already held to be deficient. Id. at *5-6. Plaintiff’s failure to warn claim was also deficient because it was not based on an alleged deficient warning to the doctor, which is required under learned intermediary doctrine. Id. *6.

Impact.

You turn and plaintiff’s claims are gone. All you can see is the aftermath, and TwIqbal rolling, ever powerful, off into the distance.

The plaintiff may get another chance, though. The court’s dismissal was without prejudice, so plaintiff might be able to replead. But she will need facts. Otherwise, you can expect TwIqbal to roll through again.

We seem to be having an administrative law moment at the DDL blog. That subject matter area is seldom sexy. It can be, frankly, quite dry. But administrative law can have a huge impact on drug and device law. Yesterday, Bexis discussed cases holding that agency rules that did not undergo required notice and comment procedures could not then be used to clobber defendants via False Claim Act claims. As the former Vice President once said in another context (because we are a G-treated, family-friendly blog, we will delete the expletive) this is a big deal.

How else could administrative law ride to the rescue of our clients? Think about how some plaintiff regulatory experts criticize drug or device makers for their alleged departures from FDA guidances. What if those guidances are not worth the paper in the Federal Register on which they are not printed? Or think about adverse regulatory actions, such as inspections, that make ugly cameo appearances in tort cases. On October 9, 2019, the White House issued a pair of Executive Orders that attempt to rein in agency rule-making that itself does not follow the rules. The two Executive Orders restrict the ability of federal administrative agencies to regulate through guidance documents. Such regulation by guidance is something that the FDA does frequently. Perhaps in the future it will happen less frequently. (Here is an example of recent FDA legislation via guidance.)

The Executive Order on Promoting the Rule of Law through Transparency and Fairness in Civil Administrative Enforcement and Adjudication (you can find it here) is more general in scope. It begins with the (we hope) unarguable proposition that agency actions should not be arbitrary and that their substantive rules and interpretations should be published in the Federal Register: “Unfortunately, departments and agencies (agencies) in the executive branch have not always complied with these requirements.” Then we get another unarguable proposition: “No person should be subjected to a civil administrative enforcement action or adjudication absent prior public notice of both the enforcing agency’s jurisdiction over particular conduct and the legal standards applicable to that conduct.” Okay. All well and good. As that great proponent of fair and humane administrative law, Vladimir Ilyich Ulyanov (known to his pals as Lenin), once asked, What is to be done?

Here is what the Executive Order requires:

“When an agency takes an administrative enforcement action, engages in adjudication, or otherwise makes a determination that has legal consequence for a person, it may apply only standards of conduct that have been publicly stated in a manner that would not cause unfair surprise.” Everybody is against unfair surprise, right? But there is more:

“Any decision in an agency adjudication, administrative order, or agency document on which an agency relies to assert a new or expanded claim of jurisdiction — such as a claim to regulate a new subject matter or an explanation of a new basis for liability — must be published, either in full or by citation if publicly available, in the Federal Register (or on the portion of the agency’s website that contains a single, searchable, indexed database of all guidance documents in effect) before the conduct over which jurisdiction is sought occurs. If an agency intends to rely on a document arising out of litigation (other than a published opinion of an adjudicator), such as a brief, a consent decree, or a settlement agreement, to establish jurisdiction in future administrative enforcement actions or adjudications involving persons who were not parties to the litigation, it must publish that document, either in full or by citation if publicly available, in the Federal Register.”

The Executive Order also affords an opportunity to contest agency determinations. Further, within 120 days of the Order “each agency that conducts civil administrative inspections shall publish a rule of agency procedure governing such inspections.” The Order insists on appropriate procedures for information collections, and instructs agencies “to encourage voluntary self-reporting of regulatory violations by regulated parties in exchange for reductions or waivers of civil penalties” and “to provide pre-enforcement rulings to regulated parties.”

That all sounds like basic fair play. The agencies and plaintiff lawyers must hate it.

Next, let’s talk about the other Executive Order (which you can find here). As its title suggests, the Executive Order on Promoting the Rule of Law through Improved Agency Guidance Documents more specifically tackles the issue of guidance abuse. The goal is “to ensure that Americans are subject to only those binding rules imposed through duly enacted statutes or through regulations lawfully promulgated under them, and that Americans have fair notice of their obligations.” The Order observes that “Departments and agencies in the executive branch adopt regulations that impose legally binding requirements on the public even though, in our constitutional democracy, only Congress is vested with the legislative power.” True enough. The growth of the administrative state is, along with advances in nuclear physics, one of the most significant developments of the 20th Century. That administrative state (again, like physics) offers as many threats as benefits.

Here is the problem: “Agencies may clarify existing obligations through non-binding guidance documents, which the APA exempts from notice-and-comment requirements. Yet agencies have sometimes used this authority inappropriately in attempts to regulate the public without following the rulemaking procedures of the APA. Even when accompanied by a disclaimer that it is non-binding, a guidance document issued by an agency may carry the implicit threat of enforcement action if the regulated public does not comply. Moreover, the public frequently has insufficient notice of guidance documents, which are not always published in the Federal Register or distributed to all regulated parties.” Also true. Also threatening.

What is the solution? The Order requires “that agencies treat guidance documents as non-binding both in law and in practice, except as incorporated into a contract, take public input into account when appropriate in formulating guidance documents, and make guidance documents readily available to the public.” Going forward, each guidance document must “clearly state that it does not bind the public, except as authorized by law or as incorporated into a contract.” There will be ‘procedures for the public to petition for withdrawal or modification of a particular guidance document, including a designation of the officials to which petitions should be directed.” There must also be “a period of public notice and comment of at least 30 days before issuance of a final guidance document, and a public response from the agency to major concerns raised in comments.” There are other requirements, as well. The result should be less bogus agency legislation-via-guidance, and more clarity as to which guidances still have any force and what the extent of that force is.

More concretely and immediately, we harbor real doubts that, for instance, the FDA’s guidance documents concerning internet promotion/off-label promotion of drugs/devices can stand in the wake of these Executive Orders. And if the guidances cannot stand as a matter of federal administrative law procedure, their ability to influence state tort litigation is even more questionable.

Last term, in a case that the Blog completely ignored, the Supreme Court held that a provision of the Medicare Act, 42 U.S.C. §1395hh(a)(2), required the Centers for Medicare & Medicaid Services (“CMS”) to subject all Medicare-related determinations “that establish[] or change[] a substantive legal standard” to formal notice-and-comment rulemaking.  Such determinations explicitly include (as per that statutory provision) “scope of benefits,” “payment for services,” and “eligibility of individuals, entities, or organizations to furnish or receive services or benefits.”  Id.  The case is Azar v. Allina Health Services, 139 S. Ct. 1804 (2019).  Allina didn’t involve anything concerning prescription medical products, so it didn’t seem particularly relevant to us.  Allina also made what appears to be a fine distinction that only administrative lawyers – that is, not us – could love:

The government’s interpretation can’t be right.  Pretty clearly, the Medicare Act doesn’t use the word “substantive” in the same way the APA does − to identify only those legal standards that have the “force and effect of law.”

139 S. Ct. at 1811.  The decision that the Supreme Court affirmed had filled in the blanks to hold:

In other words, as relevant here, the Medicare Act requires notice-and-comment rulemaking for any (1) “rule, requirement, or other statement of policy” that (2) “establishes or changes” (3) a “substantive legal standard” that (4) governs “payment for services.” Id. §1395hh(a)(2). . . .  “Substantive law” is law that “creates, defines, and regulates the rights, duties, and powers of parties.”  A “substantive legal standard” at a minimum includes a standard that “creates, defines, and regulates the rights, duties, and powers of parties.”

Allina Health Services v. Price, 863 F.3d 937, 943 (D.C. Cir. 2017) (citation omitted), aff’d, 139 S. Ct. 1804 (2019).

So what?  Get to the point.

To put it bluntly, Allina may well mean “sayonara” for a lot of False Claims Act litigation, including those bedeviling our prescription medical product manufacturing clients – because CMS has been shirking its regulatory responsibilities for many years.  So said a judge in our neighborhood, just the other day.  See Polansky v. Executive Health Resources, Inc., 2019 WL 5790061 (E.D. Pa. Nov. 5, 2019).  Polansky also involved reimbursement, and it followed these logical steps:

  1. The Medicare Act required CMS to subject all “substantive legal standards” to notice and comment rulemaking. 1395hh(a)(2).
  2. Allina held that “substantive legal standards” swept more broadly than just what had force of law under the Administrative Procedure Act.
  3. The District of Columbia Circuit got it right on what “substantive legal standards” did mean in §1395hh(a)(2).
  4. The standard at issue in Polansky affected how much somebody could get reimbursed by Medicare, and thus was a “substantive legal standard.”
  5. CMS (as with virtually everything else it has done) didn’t use notice-and-comment rulemaking.
  6. Therefore the improperly promulgated standard could not be enforced by anybody by means of the False Claims Act.

That last step, of course is the most important one, so we’ll quote Polansky’s holding directly:

The determinative issue in this Court’s Allina analysis is whether the . . . policy referenced in the 1989 Manual and its predecessors is a “substantive legal standard” within the scope of Section 1395hh(a)(2).  If so, then Relator’s . . . claims fail as a matter of law, because it is undisputed that the . . . policy did not go through notice and comment as required by Section 1395hh(a)(2) for substantive legal standards.  Applying the definition elucidated by the District of Columbia Circuit, it is clear that the . . . policy contained in the CMS manual is a “substantive legal standard” and therefore required notice and comment rulemaking procedures.

Polansky, 2019 WL 5790061, at *14 (emphasis added).  With respect to any “substantive legal standard” “contained in agency manuals that had not been promulgated pursuant to notice and comment, Allina compels the conclusion that there can be no FCA liability.”  Id. at *16.

That’s a big deal.  It’s almost like preemption, since it doesn’t matter how strong or weak (and the court thought these claims were pretty weak, see id. at *8-10) the FCA claim is, if such a claim is based on something CMS did that hasn’t gone through notice-and-comment rulemaking, the claim fails.  So every pending Medicare-related FCA claim – including all claims against prescription medical product manufacturers or suppliers − needs to be examined for invalidity under Allina.

Perhaps fittingly Polansky was decided on Election Day.  In the Eastern District of Pennsylvania at least, it was time to throw the bum FCA claims out.

We’ve been backing the proposition that the Erie doctrine concerning federal courts’ prediction of state law precludes courts clothed only with diversity jurisdiction from expanding state tort liability in novel ways since just about the beginning of the Blog.  However, our analyses have tended to be forward looking.  We typically start with the Supreme Court’s definitive statement in Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3 (1975), that federal courts are “not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.”  Id. at 4.  We then typically address ourselves to the law of circuit where the infraction arose.

Today, we’re mostly going in the opposite direction to discover the genesis of this principle, although we will keep an eye out for other United States Supreme Court precedent to the same effect.  Erie conservatism, of course, has its origins in the Supreme Court’s seminal directive in Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938) (Brandeis, J.), that, “[e]xcept in matters governed by the Federal Constitution or by Acts of Congress, the law to be applied in any case is the law of the State.”  Id. at 78.  Erie condemned federal courts’ disregard of state law “which is often little less than what the judge advancing the doctrine thinks at the time should be the general law on a particular subject.”  Id.  Federal judges may not “brush[] aside the law of a state in conflict with their views.”  Id.

Expressing core constitutional principles of federalism, the Court in Erie declared that “no clause in the Constitution purports to confer . . . power upon the federal courts” to “declare substantive rules of common law applicable in a state.”  Id. at 78.  When a federal court “declare[s]” a substantive rule of state law not firmly anchored in clear state legislative or decisional authority, it “invade[s] rights which . . . are reserved by the Constitution to the several States” and engages in “an unconstitutional assumption of [state] powers.”  Id. at 79-80.  Erie thus restored the States’ prerogative to “define the nature and extent” of a litigant’s rights, an “object [that] would be thwarted if the federal courts were free to choose their own rules of decision whenever the highest court of the [S]tate has not spoken.” West v. AT&T Co., 311 U.S. 223, 236 (1940).

Subsequent high court decisions have recognized that “Erie was deeply rooted in notions of federalism.”  Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988).  Erie sought to achieve, or at least shoot for, “twin aims”:  “‘discouragement of forum-shopping and avoidance of inequitable administration of the laws[.]’” Salve Regina College v. Russell, 499 U.S. 225, 234 (1991) (quoting Hanna v. Plumer, 380 U.S. 460, 468 (1965)).  The comity between the respective powers of the states and federal courts that Erie required was “fundamental to our system of federalism.”  Johnson v. Fankell, 520 U.S. 911, 916 (1997).  Erie principles thus prohibit “federal judges” from “displac[ing] the state law that would ordinarily govern with their own rules of federal common law.”  Boyle, 487 U.S. at 517.  Thus, “a federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.”  Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

This intent to preserve our system of federalism should inform a federal court’s Erie analysis.  When a state’s highest court has decided the issue at hand, its ruling “is to be accepted by federal courts as defining state law.”  West, 311 U.S. at 236.  When that has not occurred, “[t]he proper function” of a federal court “is to ascertain what the state law is, not what it ought to be.”  Klaxon Co. v. Stentor Electric Manufacturing Co., 313 U.S. 487, 497 (1941).  “[I]t is the duty of the [federal judge] in every case to ascertain from all the available data what the state law is and apply it rather than to prescribe a different rule, however superior it may appear.”  West, 311 U.S. at 237.  Diversity jurisdiction “does not carry with it generation of rules of substantive law.”  Gasperini v. Center for Humanities, Inc., 518 U.S. 415, 426 (1996).

As the above discussion demonstrates, while the Supreme Court’s admonition in Day & Zimmerman against federal courts “engraft[ing]” novel liability onto existing state tort law is the most direct statement of Erie-based conservatism with respect to state law, it is not the only – or even the most recent – expression of this principle.  The doctrine did not arise, full-blown, in Day & Zimmerman, like Athena springing from the head of Zeus.  Rather, the principle of Erie conservatism has strong and deep roots in the Court’s Erie jurisprudence, that reach back to Erie v. Tompkins itself.

 

Plaintiffs in (mostly) prescription drug cases have tried, with decreasing success, to limit the scope of implied impossibility preemption under the Mensing/Bartlett line of supreme court precedent to generic drugs.  It’s not a particularly satisfying rationale, but the simple claim that “those were generic drug cases” did at least convince some courts that really wanted to be convinced.  In response to that, we highlighted (among other things) Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 702-03 (3d Cir. 2016), which applied Mensing/Bartlett preemption principles outside of the FDCA context altogether – to a product liability case involving an airplane crash.

The proposition is that of course implied impossibility preemption principles, as enunciated by Mensing and Bartlett, apply to non-generic drugs.  Implied preemption principles are not governed by any particular statutory scheme, so not only does Mensing/Bartlett preemption apply to all aspects of the FDCA, they apply to any statutory scheme presenting similar federal/state conflict issues.

Well, now we have another example of a fortiori application.  The same impossibility preemption rationale, based mostly on Bartlett, applied recently to a case that didn’t even involve product liability, but rather banking.  See Anderson v. Wells Fargo Bank, N.A., 2019 WL 4773972 (D.S.D. Sept. 30, 2019).  Anderson involved purported wrongful discharge claims by certain bank employees based on those employees’ past criminal records.  Here is the conflict:

A federal statute . . . requires [defendant] to investigate an individual’s criminal history before hiring them.  [Defendant] may not hire individuals convicted of certain offenses without [prior agency] consent.

Id. at *1 (citations omitted).  Plaintiffs all had disqualifying convictions that they did not disclose and that were missed in an earlier, less comprehensive background check.  Id. at *2.  Once a better database became available, defendant rescreened plaintiffs (with their consent).  The rescreening revealed the disqualifying convictions, and as required by federal statute, plaintiffs were discharged.  Id.

Plaintiffs’ suit for supposed “fraudulent” termination ran headlong into preemption under Bartlett.

State law is “impliedly pre-empted where it is impossible for a private party to comply with both state and federal requirements.”  Plaintiffs here assert [defendant] should not have fired them when it became clear they were . . . ineligible. . . .  If the court concluded plaintiffs’ state law liability claims were not preempted, [defendant] would be confronted with an impossible choice: face potential federal liability under . . . for employing ineligible individuals or face state law liability for “fraudulently” terminating employees.  [The federal statute] “prohibited [defendant] from taking the remedial action required to avoid liability under” plaintiffs’ theory of the case.

Anderson, 2019 WL 4773972, at *6 (two Bartlett citations omitted).  Because defendant “cannot comply both with [federal law] and with the state law fraud statutes as plaintiffs construe them” the claims in Anderson were preempted.  Id.

While the statute provided an exception if prior agency consent was obtained, such consent had not been sought, and after the fact that pre-approval requirement.  Defendant “did not have an option to suspend plaintiffs’ employment to allow them to obtain a waiver.”  Id. at *7.  The case thus presented a classic Mensing/Bartlett impossibility preemption situation, where immediately applicable common-law claims had to give way in the face of mandatory pre-approval by a government agency.  There was no “general fraud exception” to impossibility preemption.  Id. (“Plaintiffs do not cite any authority for a more general fraud exception to preemption law and the court is aware of none.”).

Our non-generic prescription drug preemption cheat sheet demonstrates that plaintiffs have been increasingly unsuccessful in their attempts to cabin Mensing/Bartlett preemption to generic drugs only.  That is as it should be.  Since implied preemption principles apply to all federal regulations, even banking, a fortiori Mensing/Bartlett preemption applies to other parts of the FDCA.