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This blog is no stranger to the In re Smith & Nephew Birmingham HIP Resurfacing (BBR) HIP Implant Products Liability Litigation, MDL 2775, pending in the District of Maryland.  Nor have we hidden our disregard for several of its decisions, going back to its preemption ruling on defendant’s motion to dismiss which made our bottom ten worst cases for 2018.  So, no we were not surprised when it handed down another disappointing preemption decision earlier this summer.  And if its decision in Albritton v. Smith & Nephew, Inc., 2021 U.S. Dist. LEXIS 153866 (D. Md. Aug. 13, 2021) (part of MDL 2775), had turned on preemption we are certain we would be sharing our further frustration.  Instead, what the court allowed to escape preemption previously, it could not save on summary judgment because plaintiff failed on causation across the board.

Plaintiff, a Florida resident, suffered hip pain because of avascular necrosis (“AVN”), a condition where the bone weakens due to a lack of blood supply.  Id. at *86-87.  Plaintiff’s surgeon discussed the treatment options with him, including undergoing a hip resurfacing using defendant’s device.  Id. at *88-89.  Plaintiff underwent the surgery in 2009.  In 2015, due to pain, he underwent a revision surgery during which it was discovered that the femoral neck of the device had fractured and loosened.  Id. *91.  Plaintiff alleges that prior to his surgery he was provided a patient guide that discussed using the device for treating AVN but did not include the increased risks and contraindications in such situations which were discussed in the device’s Instructions for Use (“IFU”).  Id. at *89-90.  Plaintiff also claimed that he relied on his surgeon in deciding to have the surgery and to select the device to use; that his surgeon told him the device would last the rest of his life, something his surgeon denies; and that he did not rely on any advertising in deciding whether to undergo the procedure with the defendant’s device.  Id. The implanting surgeon testified that he was familiar with the device’s IFU and that he was aware, prior to plaintiff’s surgery, that AVN patients were at an increased risk for needing revision surgery, but that defendant’s device was the best option for plaintiff.  Id. at *92-93.

Plaintiff’s causes of action were for negligent failure to warn, negligent misrepresentation, negligence per se, breach of express warranties, and negligent training.  The court addressed each in turn.  The court declined to determine whether Florida law would recognize a failure to warn claim based on an alleged failure to report adverse events to the FDA.  That’s fine with us because based on precedent, it would likely have ignored Florida law anyway.  But, if you want to know the answer, it is – Florida does not – as we discuss here.  Instead, the court focused on causation.  Plaintiff had no evidence that any information defendant was required to report to the FDA would have been made public in such a way as to have reached plaintiff’s implanting surgeon in time to alter his decision regarding using the device.  Id. at *97-98.  We’ve been talking about the causation problems with failure to report claims since Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) was decided.  So, that the claim was ultimately dismissed is not surprising.  That it should have dismissed because its not a claim under Florida law is disconcerting, but we’ll take the win.

On negligent misrepresentation, plaintiff also had a causation problem.  First, his experts opined that that defendant did not make any misrepresentations regarding the risk of revision and the particular device used in plaintiff’s surgery.  Id. at *99-100.  Second, although plaintiff attempts to point out omissions in the patient guide, the record evidence is that plaintiff did not rely on the patient guide in deciding to have the surgery.  Id. at *100-101.  Third, plaintiff could not prove that his implanting surgeon relied on any misrepresentation by defendant.  The surgeon testified that he read the IFU and was aware of the risk of revision prior to performing the procedure.  Plaintiff argued that there were ad hoc reports of adverse events that were not in the materials provided to his surgeon.  One such report which may have been available prior to plaintiff’s surgery purportedly showed a revision rate for AVN patients closer to 9.8% as opposed to the 7.9% revision rate in the IFU.  Id. at *103-104.  But there is no testimony from the implanter that such information would have changed his decision.  The remaining ad hoc reports plaintiff relies on post-date his surgery and therefore “do[] not assist the factfinder in identifying what [defendant] knew before [plaintiff] had the [device] implanted.”  Id. at *104.  Without reliance by himself or his doctor, plaintiff failed to establish any alleged misrepresentation was a cause of his injury.

Plaintiff’s breach of express warranty claim failed for the same lack of causation.  The patient guide was the only direct communication between the defendant and the plaintiff and plaintiff disavowed any reliance on it.  Id. at *107-108.  To the extent plaintiff tried to rely on his surgeon alleging telling him the device would last his lifetime, plaintiff cannot attribute that statement to the defendant.  His surgeon denies making the representation, but regardless plaintiff has no proof defendant was the source.  Id. at *108.

On failure to train, the court adopted its earlier ruling finding the claim preempted because attempts to add training requirements not imposed by the FDA violated the FDCA’s “different from or in addition to” language.  Id. at *109.

Finally, plaintiff attempted a negligence per se claim based on Florida’s “Little FDCA” statute which prohibits misbranding.  But such a claim would require plaintiff to challenge the adequacy of the FDA-approved label and therefore, it was preempted.  Id. at *109-110.

 

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Not long ago we pointed out, in our discussion of In re: Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp. ___, 2021 WL 2865869 (S.D. Fla. July 8, 2021), that court’s pithy takedown, in a preemption situation, of plaintiffs’ widespread habit of seizing upon some factual variation and calling it a new “duty” that had not yet been held preempted by prior case law.  Zantac put the kibosh on this, pointing out that “mere[] fact patterns” are not new “duties:”

The Court rejects the Plaintiffs’ theory that “sub-duties” are cognizable (and divisible) legal duties, let alone the duties to be used for comparison in federal pre-emption analysis. . . .   [T]hey do not fit within the required paradigm for pre-emption analysis.

Id. at *16-17.  Bingo.  Once duty to warn is held preempted (as held in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), for PMA medical devices, and in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), for generic drugs), it’s preempted, regardless of salami-slicing seeking to create claims for “warning-based design defect,” “failure to train,” “failure to test,” “failure to report,” “failure to supply medication guides,” “failure to conduct studies,” “failure to update,” and whatever other fact pattern plaintiffs dream up to disguise warning-based allegations as something other than the preempted warning claim they are.

We’ve also seen the same thing in design defect cases, which are also preempted by Riegel, for PMA devices, and by Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), for generic (and we would say all, id. at 477 (“whether generic or brand-name”)) drugs.  Plaintiffs’ primary dodge has been an attempt to split the hitherto monolithic “design defect” claim into “pre-approval” and “post-approval” design defects.  As have the better reasoned decisions, we’ve condemned that effort here, and in a number of other posts.  It’s another transparent dodge, allowed only by courts with their own anti-preemption agendas, as we have yet to see any case drawing such a distinction in a non-preemption case.

This post is about the equally illegitimate offspring of both of the just-described trends, purported claims for “pre-approval” warning defects.  We became aware of this latest attempt at a warning-based sub-duty reading the awful decision on this point in Stube v. Pfizer, Inc., 446 F. Supp.3d 424 (W.D. Ark. 2020).  In response to a drugmaker’s implied preemption argument, Stube held:

Although defendants are correct in stating the labeling language must not deviate from that which was approved by the FDA, defendants still possessed the ability to implement stronger warning language into labeling by submitting stronger warning language for initial FDA approval.

Id. at 436-37 (citations and quotation marks omitted).  The two cases Stube cited for this proposition are two of the most putrid cases in prescription drug preemption history, Holley v. Gilead Sciences, Inc., 379 F. Supp.3d 809, 826 (N.D. Cal. 2019), which we lambasted here and here for various sins, including being the worst trial-court level decision of the year.  The other, and the one the originated the quote, is In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 60298, at *7 (W.D. La. Jan. 7, 2014).  We didn’t discuss that particular decision, but we:  (1) did nominate that particular MDL for ATRA’s first ever federal-court “judicial hellhole”; (2) pointed out that Actos procedural rulings were so universally viewed as unjust and prejudicial to defendants that they prompted change in the Federal Rules; and (3) slammed Actos MDL expert decisions as “a rare pentalogy of drecky decisions.”  So it’s safe to say that the Actos first-ever allowance of a “pre-approval warning” claim was par for the course from an extreme pro-plaintiff judge who had no business ever running an MDL.

That’s the bad stuff.

On the sane end of the spectrum is the appellate case that Stube refused to follow – starting with In re Celexa & Lexapro Marketing & Sales Practice Litigation, 779 F.3d 34 (1st Cir. 2015).  There, plaintiffs alleged “the FDA’s acceptance of the questionable data” in approving the warnings concerning a drug.  Id. at 38.  Because of that, plaintiffs alleged that the defendant’s labeling was defective ab initio.  That claim was preempted because there was zero chance that “newly acquired information,” and thus the ability to change warnings unilaterally under the FDA’s “changes being effected” (CBE) regulation, could exist at the time of a drug’s initial FDA approval:

To the extent that the underlying policy issue is one of who decides whether and how a drug can be marketed, the line so drawn lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing the states to reach contrary conclusions when new information not considered by the FDA develops.  The CBE regulation, too, covers virtually all situations in which new information indicates new or greater risks, or misleading claims of efficacy.  By hinging preemption on the availability of that procedure in a particular case, [Levine] effectively reserves the launch of new drugs to the expertise of the FDA, but then preserves a wide scope for the states in requiring manufacturers to respond to information not considered by the FDA.

Id. at 41 (footnote omitted).  Delimiting preemption in this fashion, made “pragmatic sense” to the First Circuit.  Id.  There was “no precedent” allowing CBE changes based on the evidence “known to the FDA at the time of approval.”  Id. at 43.

Numerous other cases, however, are in accord with Celexa’s refusal to allow an unpreempted pre-approval warning claim.  Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 660 (S.D.N.Y. 2017), aff’d, 919 F.3d 699 (2d Cir. 2019), which Stube clumsily attempted to distinguish without admitting it, was actually adverse, 446 F. Supp.3d at 437 n.7, in fact roundly rejected purported warning defects at the pre-FDA-approval stage.  Reading Levine, Mensing, and Bartlett “holistically,” Utts concluded:

[F]ederal law preempts all pre-FDA approval failure to warn and design defect claims for branded prescription medication. . . .  [B]rand name drug manufacturers lack the authority to alter a drug’s design or a label’s warnings at the time the NDA approval process concludes.  State law claims that challenge labeling that FDA approved after being informed of the relevant risk are preempted.

251 F. Supp. at 660 (citations and quotation marks omitted).

In Mitchell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 5617473, at *4-5 (W.D. Tenn. Nov. 21, 2017), the court recognized that attacking a drug warning prior to FDA approval was preempted by the fact of FDA approval of the exact labeling:

[A]ny claim that Plaintiff has made against Defendant based on the alleged inadequacy of the initial FDA approved label fails as a matter of law because Defendant was required to use that label when it first marketed [the drug] and could not have changed the label after FDA approval based on alleged pre-launch data that was known to the FDA at the time of the approval. . . .  The FDA’s premarket approval of a new drug application includes the approval of the exact text in the proposed label. . . .  Thus, [the drug] would have been misbranded if, upon approval, Defendant had marketed [it] with labeling other than what the FDA approved. . . .  Accordingly, Plaintiff’s allegation that [the drug] was unreasonably dangerous because of its labeling at the time it was first marketed on August 1, 2014, and the allegation that [defendant] should have provided a different label . . . on August 1, 2014, is preempted by federal law.

Id. at *4-5 (citations and quotation marks omitted).  Other decisions reaching the same result concerning the same claims about the same drug are:  McGee v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 1399237, at *4 (N.D. Ala. March 20, 2018) (“To the extent [plaintiff] asserts that [defendant] should have alerted the FDA about [the drug’s claimed] risk before [its] approval, the claim is preempted because the claim is essentially one of failure to communicate with the FDA. Federal law preempts state-law claims based on a defendant’s failure to communicate with the FDA.”); MacMurray v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 11496825, at *5-6 (D. Utah Dec. 6, 2017) (“To the extent that Plaintiff’s failure-to-warn claims are premised on the adequacy of the label as approved by the FDA when [the drug] was first marketed in the United States, they are preempted.”)

Similarly, In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761 (D.S.C. 2016), held that attacks on labeling statements that the FDA “specifically approved” was preempted.  Id. at 669.  Following Celexa, Lipitor confirmed that “any claim that a drug label should be changed based on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.”  Id.  See also Maze v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 1062387, at *3 (E.D. Tenn. March 6, 2019) (“any claim asserted by [plaintiff] and based on information known to the FDA as of [the date] − when the label at issue here was approved − is plainly preempted by federal law”); In re Genentech Herceptin (Trastuzumab) Marketing & Sales Practices Litigation, 2017 WL 9939631, at *4 (N.D. Okla. May 8, 2017) (“communications occurring prior to FDA approval are not relevant to impossibility preemption”); In re Plavix Product & Marketing Cases, 2017 WL 6812239, at *3 (Cal. Super. Dec. 1, 2017) (“an attack on the initial label is preempted”).

As recognized by the Supreme Court four times now (in Levine, Mensing, Bartlett, and Albrecht) there is only one way for a plaintiff to avoid preemption in a prescription drug case involving warning – to show “newly acquired information” such that the defendant could have unilaterally made the label change at issue under the FDA’s CBE regulation without the need to seek prior FDA approval.  Otherwise, simultaneous compliance with federal and state law is impossible.  Such newly acquired information evidence, by definition, cannot exist at the moment of FDA approval.  Therefore, novel theories asserting some sort of separate claim for “pre-approval warning defect” are necessarily preempted.

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We find ourselves, once again, hungry for good news.  We just canceled a trip to see dear friends outside of Glacier National Park because Montana hospitals are so overfilled with anti-vax COVID patients that anyone with any medical emergency risks being turned away.  Afghanistan fell to the Taliban.  And, on a more “micro” level, we repaired to the basement late last night in the face of a tornado warning to discover a sheet of water pouring in between the pane and the frame of our brand-new basement window.  We assume the thousands of dollars we paid for this window and its companions will entitle us to a replacement, but, suffice it to say, this was not a welcome development.  (We feel compelled to reiterate that none of this affects our ongoing gratitude for health, family, and vaccines.  But that doesn’t stop us from complaining.)

Once again, we find solace in an aggressive judge sensibly construing Pennsylvania law and displaying no tolerance for the sloppy pleadings that so often survive dismissal.  In McGrain v. C.R. Bard, Inc., 2021 WL 3288601 (E.D. Pa. July 30, 2021), the plaintiff alleged that she was injured by the defendant’s inferior vena cava (“IVC”) filter, implanted in her after she was diagnosed with pulmonary embolus and deep vein thrombosis.  She alleged that two struts of the IVC filter perforated her inferior vena cava, causing her “pain and discomfort in her abdominal area.”   McGrain, 2021 WL 3288601 at *1.   She filed suit in the Eastern District of Pennsylvania asserting the usual litany of product liability claims sounding in strict liability, negligence, and breach of warranty, and the defendant moved to dismiss all of the claims because they were not recognized under Pennsylvania law and/or because the plaintiff had not alleged sufficient facts to render the claims plausible.

Strict Liability

The plaintiff asserted strict liability design defect, manufacturing defect, and failure-to-warn claims.  The defendant moved to dismiss all three, arguing that, under Pennsylvania law, comment k barred strict liability claims against prescription drug manufacturers.  Readers of this blog will recall numerous posts about this issue during the past few years.  As we have explained, comment k (addressed by the Pennsylvania Supreme Court most recently in its 1996 Hahn decision) bars strict liability claims against manufacturers of “unavoidably unsafe products,” expressly including prescription drugs.  Decades of appellate jurisprudence has reached the (obviously correct) conclusion that there is no principled basis upon which to distinguish prescription medical devices from prescription drugs so the preclusive effect of comment k applies equally to prescription medical devices, like the IVC filter.

But a number of Pennsylvania federal district court decisions have gone rogue, in recent years, misconstruing Lance and Tincher to hold that comment k does not bar strict liability claims against medical device manufacturers, while others have stayed the course and continued to reach the opposite (and correct) holding.  We explained all of this here, just last week, when we announced that the Pennsylvania Supreme Court had granted review of this very question, certified to it by the Eastern District of Pennsylvania.

The appeal has yet to be heard, but, thankfully, Judge Nitza Quinones, presiding over McGrain, is in the sensible camp, having “previously held that such claims” against device manufacturers “are barred under Pennsylvania law.”  Id., citing Lopez v. Ethicon, 2020 WL 5569770 at *5 (E.D. Pa. Sept. 17, 2020).   (We apologize for the absence of pin cites.  Our Westlaw copy does not include “star page” numbers.)   In this case, stating, “Plaintiff provides this court with no reason why it should depart from its previous holding,” Judge Quinones again held that comment k barred the strict liability design defect and warnings claims.

The plaintiff expected this result, and effectively conceded in her opposition brief that these claims were doomed.  But she argued that her strict liability manufacturing defect claim was, nevertheless, viable.  The court described the split among federal district courts applying Pennsylvania law as to whether such a claim was cognizable against a medical device manufacturer.   (Lopez had not addressed this issue.)  The plaintiff argued that Tincher permits such claims “provided the evidence is sufficient to prove a [manufacturing] defect.” but the court disagreed, emphasizing that Tincher was not decided in the prescription drug or device context and that the Tincher court acknowledged this with a “but see” citation to Hahn.

As the McGrain court explained, Hahn addressed strict liability design defect and warnings claims but not manufacturing defect claims.  But the comment k language on which the Hahn court relied provided that “unavoidably unsafe products” were not defective or unreasonably dangerous if they were “properly prepared and accompanied by proper . . . warning.”  The court held, “Plaintiff has offered no basis, and this Court is unaware of any, on which the Pennsylvania Supreme Court could interpret “properly prepared” any differently than it interpreted and applied “accompanied by proper directions and warning.”  Id.  Accordingly, bolstered by the language of Lance and a page-long string cite of decisions refusing to differentiate among strict liability claims, the court predicted that the Pennsylvania Supreme Court “would extend its reasoning in Hahn to preclude strict liability manufacturing defect claims against medical device manufacturers.”  Id.

The court dismissed the “breach of implied warranty of merchantability” claim for the same reasons, following other courts in the district that had held that there can be no “implied warranty,” whether of merchantability or fitness for a particular purpose, for “unavoidably unsafe products” like prescription medical devices.  And just that quickly, simply by viewing the case through the correct lens, the court dismissed the strict liability and warranty claims with prejudice

Negligence Claims

Next, the court moved on to the plaintiff’s claims sounding in negligence:  negligent manufacturing, negligent design, and negligent failure to warn.  The defendant’s motion argued that the plaintiff had failed to allege fact sufficient to plausibly plead the requisite elements of any of these claims, and the court agreed.   With respect to the manufacturing claim, the court stated, “As Defendants correctly point out, none of [the allegations in the Complaint] alleges facts concerning Defendants’ actual manufacturing process. . . . Without any factual allegation as to the nature of what went wrong during the manufacturing process, Plaintiff cannot plausibly state a claim for negligent manufacturing.”  Id. (internal punctuation and citation omitted).

Similarly, the negligent design allegation “fail[ed] to address either the design of Defendants’ product or the availability of safer, feasible alternatives in any level of meaningful detail.”  Noting that “courts in this district have consistently dismissed claims resembling Plaintiff’s as insufficiently pled,” the court held, “. . . [B]ecause Plaintiff fails to allege facts sufficient to plausibly state a negligent design claim, this claim is dismissed.”  Id. 

Finally, with respect to the negligent failure to warn claim, the defendant argued that the claim was “bereft of any facts about the warnings on the [product], its labeling, packaging, or other associated materials.”  The court agreed, holding, “[The] allegations do not specify what information was missing from Defendants’ warnings.  Nor do any of the allegations address the precise injury posed ty the use of the device.  Without this information, Plaintiff has not plausibly stated a connection between her alleged injuries and Defendants’ failure to warn.  Plaintiffs’ negligent failure to warn claim is, therefore, dismissed.”  Id. 

Other Claims

The same fate awaited the plaintiff’s remaining claims:  the express warranty claim was dismissed because it did not “specifically cite the language that Defendants used in the promotion of [the] product, establishing the fact or promise created. In fact, it did not “provide any ‘express’ language used in the purported express warranty at all.”  The fraudulent concealment claim was dismissed because there is no such independent cause of action under Pennsylvania law – fraudulent concealment is an equitable tolling doctrine, not an independent tort. The fraudulent and negligent misrepresentation claims were “exactly the type of dressed-up failure to warn claims that other courts have rejected.” (citation omitted).  Finally, because the plaintiff “acknowledge[d] that she received and used Defendant’s product,” she could not “plausibly state a claim for unjust enrichment.”  Id.

In the end, the court dismissed all of the strict liability claims with prejudice, along with claims for breach of implied warranty, fraudulent concealment, and unjust enrichment.  The plaintiff was granted leave to amend the negligence, express warranty, and misrepresentation claims, as these claims “suffer[ed] from mere pleading inadequacies.”   We love this decision, and we love this judge’s no-nonsense approach to the “rushing water” threatening to sweep this case along notwithstanding the dearth of colorable claims.  We have little faith that the plaintiff can cure the deficiencies of her complaint, and we’ll let you know if we see further motion practice.  In the meantime, stay safe out there.

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Nearly six years ago, in 2015, the FDA attempted to slip a change to its “intended use” regulations (21 C.F.R. §§201.128, 801.4) – which had not been updated since the 1950s – through the administrative process by hiding it in a Federal Register notice about electronic cigarettes.  80 Fed. Reg. 57756 (FDA Sept. 25, 2015).  We caught them, and the FDA then faced the prospect of responding to public comments about the First Amendment and truthful “promotion” of off-label use.

Although the method raised our eyebrows, the proposed change itself was (and is) quite necessary.  The FDA proposed to delete problematic (albeit largely unenforced) language from those regulations, which purported to make mere knowledge of off-label use a basis for changing a product’s “intended use,” setting off a cavalcade of regulatory consequences, including the product being declared misbranded and adulterated.

As we’ve pointed out elsewhere, these long-outdated “intended use” regulatory provisions are the linchpin in the agency’s prohibition of any “promotion” of off-label uses – even truthful and scientifically valid off-label information.  As we’ve discussed many times, a flat prohibition of a particular class of speakers’ (regulated product manufacturers) truthful speech on a particular topic (off-label use of their products) has become increasingly problematic under the First Amendment, given a string of Supreme Court decisions, most notably:  Reed v. Town of Gilbert, 576 U.S. 155 (2015) (content-based and speaker-based governmental restrictions are subject to strict scrutiny); Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011) (pharmaceutical detailing is First Amendment protected); and Thompson v. Western States Medical Center, 535 U.S. 357 (2002) (striking down similar FDA prohibition of a different category of truthful speech by regulated entities).  Ever since the FDA lost United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), the government has avoided appellate review of truthful off-label promotion cases, with good reason.

Back to the administrative front.

On January 9, 2017, on the eve of a change of administrations, the FDA tried a bait-and-switch “clarification” of its proposed amendments.  Instead of simply deleting the problematic language (“with the knowledge of such persons or their representatives”), the FDA retained mere knowledge and folded it into a brand new – and never commented on – “totality of the evidence” test for deeming the creation of a new intended use.  82 Fed. Reg. 2193, 2206 (FDA Jan. 9, 2017).  This would-be final rule ignored the First Amendment problems with continued prohibition of truthful, non-misleading off-label information by claiming the First Amendment would be dealt with in parallel proceedings.  Id. at 2209.  Simultaneously, however, the FDA released a “memorandum” enunciating essentially the same crabbed view of the First Amendment that had failed in Western States and Caronia (and elsewhere).  We discussed that, here.

Those parallel proceedings never amounted to anything.

The 2017 proposed rule was delayed, and then withdrawn, before it ever went into effect, as we discussed here.  Thereafter, the FDA did essentially nothing for the rest of TFG’s administration, until September 23, 2020, when FDA reissued a proposed rule that was similar to the original 2015 proposed rule, in that the “totality of the evidence” was dropped.  In the 2020 proposal, a regulated entity’s knowledge of off-label use would not be used against it in determining a new intended use.  85 Fed. Reg. 59718 (FDA Sept. 23, 2020). We discussed that proposal here.

Well, the 2020 proposed rule has now been finalized, but unfortunately, totality of the evidence is still there – just in the comments, rather than the actual language of the amended regulations.  We note the response to comment two.

[I]n determining a product’s intended use, the Agency may look to any relevant source of evidence, including a variety of direct and circumstantial evidence.  FDA’s position is reflected in the notices issued in this rulemaking over the past 5 years, and has been noted in court decisions.  This position has also been explained in numerous litigation briefs and other FDA pronouncements. . . .  One of the purposes of this rulemaking is to put to rest any dispute about FDA’s interpretation of its statute and regulations, and its policy—as embodied in this rule as well as in the precedent cited above—regarding evidence that may be relevant to establishing intended use.

Id. at 41388-89 (citations and bullet points omitted).

This response strikes us as highly unusual, particularly given the long and convoluted history of this regulatory change.  (A) The FDA proposes a relatively simple change.  (B) The FDA springs “totality of the evidence” on everyone.  (C) The agency retreats.  (D) The FDA deletes “totality of the evidence” from the regulatory proposal.  (E) Finally while omitting the concept from the language of the regulation itself, the FDA resuscitates totality of the evidence in its response to comments.  To us, all this seems like playing fast and loose with the whole notice and comment procedure.  Having explicitly proposed a “totality” test in 2017, and then withdrawn it under fire, we don’t think the new regulatory language can properly be interpreted to include by implication what was explicitly deleted.  Nor do we think the FDA is likely to find much judicial deference, given this regulatory history.  Recall that the FDA was slapped down by the District of Columbia Circuit on another off-label issue not long ago.

We also think that it’s high time that the FDA joined the rest of the world and start calling off-label use “off-label use.”  The phrase this rule uses is a clumsy mouthful – “unapproved use of a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification.”  85 Fed. Reg. at 41385.

Finally, with respect to the First Amendment itself, the FDA doesn’t seem to have learned anything from the last decade.  The great majority of the cases they cite involve illegal distribution of drugs and devices for recreational or other non-therapeutic purposes.  Id. at 41387.  Heck, those are the cases the FDA should win – we want it to win − and there’s something wrong if the agency doesn’t.  However, those aren’t the cases that concern us.  The off-label promotion this Blog has supported is truthful, therapeutic, and supported by scientific evidence.  When is the last time the FDA has won one of those?  Or even prosecuted one of those (Maybe here)?

The FDA discusses using “truthful” speech as “evidence” of intent.  Id. at 41391-91.  In the situations we’re concerned with, that distinction is well nigh meaningless.  Conducting, say, medical education concerning off-label uses, is solely speech.  There is no need for “evidence” of intent in these situations.  Intent is admitted.  Such speech is intended to inform medical personnel about off label uses.  In these situations, it is likely that the FDA – if and when challenged – will lose the First Amendment argument.

We were particularly interested in how the FDA would address the Reed line of First Amendment cases, since the agency’s ban on truthful speech about off-label uses is unquestionably both content and speaker based.  That ban is not directed against any subject except off-label use, and it is not directed against any speakers other than those the FDA regulates.  We find the FDA’s position in its response to comment 15.  Id. at 41393-94.  There are four relevant paragraphs.

In paragraph one, the FDA points out that neither Sorrell nor any of several circuit court opinions have “overruled” Central Hudson Gas & Electric Corporation v. Public Service Commission, 447 U.S. 557 (1980).  85 Fed. Reg. at 41394.  That’s a strawman.  Even we don’t think the Gilbert line of cases overruled Central Hudson.  Rather, the plain implication of these cases is that they limit Central Hudson – excluding from its reach truthful topic-based and speaker-based speech.  The Central Hudson test, after all, does not ask who the speaker is or the subject of the speech:

In commercial speech cases, then, a four-part analysis has developed.  At the outset, we must determine whether the expression is protected by the First Amendment.  For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading.  Next, we ask whether the asserted governmental interest is substantial.  If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and whether it is not more extensive than is necessary to serve that interest.

447 U.S. at 566.  There’s nothing in this test inherently contradicting the Reed line of cases reaffirming strict scrutiny of commercial speech restrictions based on subject matter or who is speaking.

Paragraph two admits, as it must, that Reed itself “applied strict scrutiny to content-based restrictions,” which the FDA characterizes as “noncommercial.”  85 Fed. Reg. at 41394.  That’s whistling past the graveyard if we’ve ever heard it.  Just as we reviewed Central Hudson, we also reviewed Reed.  One of the subject-matter restrictions struck down in Reed was precisely a distinction between commercial and noncommercial speech.  576 U.S. at 160 (“first” substantive category of struck-down ordinance was a “sign communicating a message or ideas for noncommercial purposes”).  Further, when the Reed Court discussed what kind of speech restrictions would be permissible, it did not draw any distinction between commercial and noncommercial subjects:

The Town has ample content-neutral options available to resolve problems with safety and aesthetics.  For example, its current Code regulates many aspects of signs that have nothing to do with a sign’s message: size, building materials, lighting, moving parts, and portability.  And on public property, the Town may go a long way toward entirely forbidding the posting of signs, so long as it does so in an evenhanded, content-neutral manner.

We acknowledge that a city might reasonably view the general regulation of signs as necessary because signs take up space and may obstruct views, distract motorists, displace alternative uses for land, and pose other problems that legitimately call for regulation.  At the same time, the presence of certain signs may be essential, both for vehicles and pedestrians, to guide traffic or to identify hazards and ensure safety.  A sign ordinance narrowly tailored to the challenges of protecting the safety of pedestrians, drivers, and passengers − such as warning signs marking hazards on private property, signs directing traffic, or street numbers associated with private houses − well might survive strict scrutiny.

Id. at 172-73 (citations and quotation marks omitted).  We don’t think it’s possible to tease a commercial/noncommercial distinction out of this discussion.

Paragraphs two and three parse two more recent Supreme Court decisions that did not command a majority on First Amendment issues:  Matal v. Tam, ___ U.S. ___, 137 S.Ct. 1744 (2017), and Barr v. American Ass’n of Political Consultants, Inc., ___ U.S. ___, 140 S.Ct. 2335 (2020).  85 Fed. Reg. at 41394.  As to Matal, the FDA raises the same strawman about overruling Central Hudson outright.  Yes, only Justice Thomas would have taken that step in Matal.  137 S. Ct. at 1769.  But only four justices would apply the Central Hudson test, as the FDA’s description admits.  The others reserved the question of strict scrutiny for a content-based commercial speech restriction.  Id. at 1764.  It should also be noted that the four justices in Matal whose opinion the FDA claims as support for its position included now former Justices Kennedy and Ginsburg, who are no longer on the Court.

Barr did not involve a content- or speaker-based restriction on speech at all.  Rather, Barr involved a form of conduct – use of robocall devices to make certain telephone calls.  140 S.Ct. at 2344 (“In plain English, the [statute] prohibited almost all robocalls to cell phones.”) (footnote omitted).  Justice Kavanaugh – who had not yet joined the Court in Matal – wrote the plurality opinion applying Reed in Barr.

As relevant here, a law is content-based if “a regulation of speech ‘on its face’ draws distinctions based on the message a speaker conveys.”  Reed, 576 U.S., at 163, 135 S.Ct. 2218.  That description applies to a law that “singles out specific subject matter for differential treatment.”  ” Id. at 169. . . .

Under [the statute], the legality of a robocall turns on whether it is “made solely to collect a debt owed to or guaranteed by the United States.”  A robocall that says, “Please pay your government debt” is legal.  A robocall that says, “Please donate to our political campaign” is illegal.  That is about as content-based as it gets.  Because the law favors speech made for collecting government debt over political and other speech, the law is a content-based restriction on speech.

140 S. Ct. at 2346 (emphasis added).  Thus, “[i]n short, the robocall restriction with the government-debt exception is content-based.  Under the Court’s precedents, a ‘law that is content based’ is ‘subject to strict scrutiny.’  Reed, 576 U.S., at 165.”  Id. at 2347.

Even without considering recently-elevated Justice Barrett’s views, it seems pretty clear after Justice Kavanaugh’s opinion in Barr (and we would say after Reed and Sorrell) that strict scrutiny of content-based restrictions on commercial speech commands a majority of the Court.

And what is the FDA’s First Amendment backup plan?

It doesn’t seem to have one.  Paragraph four of its Reed analysis, to use another metaphor, sticks the agency’s head in a hole in the ground – simply refusing to consider that its off-label promotion ban may be barred by the First Amendment:

Accordingly, given that the Supreme Court has not overruled Central Hudson or Wisconsin v. Mitchell and given that the laws being reviewed in the cited cases were quite different from the premarket review provisions of the [FDCA], we believe it would be wrong to conclude that the Supreme Court has implicitly but sweepingly reversed these long-standing precedents to invalidate the regulatory regime under the [FDCA].  And even if some form of heightened scrutiny were applicable to reliance on speech as evidence of intended use, FDA believes that the public health necessity of the premarket review provisions discussed in this preamble, including its references, justifies and necessitates this regime under any standard.

85 Fed. Reg. at 41394.

We have to assume that at least some of the commentators whose views the FDA just rejected have been giving some thought to their next legal steps.  We hope and expect that someone will challenge the administrative bona fides of the FDA’s on-again-off-again-on-again “totality of the evidence” approach to squelching truthful off-label speech.  We also expect to see test cases in the reasonably near future presenting, on favorable facts, the position that the FDA is acting unconstitutionally in imposing a facially content- and speaker-based ban on such speech.

To the FDA − stealing one of King George’s lines in “Hamilton” – “Good luck.”

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We’ll get to the recent Second Circuit decision, Ignacuinos v. Boehringer Ingelheim Pharms., Inc., — F.4th —-, 2021 WL 3438355 (2d Cir. 2021), in due course, but first some background.

One of our top ten decisions in 2018 was Gustavsen v. Alcon Labs., Inc., 903 F.3d 1 (1st Cir. 2018), an important implied-preemption decision. In a one-two punch, Gustavsen held (1) that federal law preempts any state-law tort claim that would require what 21 C.F.R. § 314.70(b) defines as a “major change” in a pharmaceutical product; and (2) that any change identified in § 314.70(b)(2) is necessarily a “major change” within the meaning of § 314.70(b).

In holding that federal law preempts any state-law tort claim that would require a “major change” within the meaning of § 314.70(b), Gustavsen—which involved prescription eye drops—confirmed that the logic of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), applied not only to generic drugs but to all FDA-approved pharmaceutical products.

As readers of this blog know, Mensing held that failure-to-warn claims targeting generic drugs are impliedly preempted because federal law requires that generic drug labels be identical to their branded counterparts. That federal requirement—the so-called “duty of sameness” embodied in 21 C.F.R. §§ 314.94(a)(8)(iii), 314.150(b)(10)—makes it impossible for a generic manufacturer to unilaterally change its label to comply with a purported state-law duty to provide different or additional warnings. Given that simultaneous compliance with state and federal law is impossible, any state-law duty to provide such warnings is preempted under the Supremacy Clause.

Bartlett built on Mensing. In addition to requiring that generic labels have the same labeling as their branded counterparts, federal law also requires that generic drugs have the same active ingredients, route of administration, dosage form, and strength as their branded counterparts. See 21 U.S.C. §§ 355(j)(2)(A)(ii)–(v) and (8)(B); 21 C.F.R. § 320.1(c). Moreover, federal law prohibits a drug manufacturer from making any “major changes” to the “qualitative or quantitative formulation of the drug product.” 21 C.F.R. § 314.70(b)(2)(i). Taken together, this means that, as a matter of federal law, a generic drug manufacturer may neither reformulate its drug nor warn of its supposed risks (unless the branded label also warns of those supposed risks). Consequently, a state-law claim predicated on a generic manufacturer’s failure to reformulate its drug or warn of the risks supposedly associated with the drug is preempted by federal law because simultaneous compliance with federal law and the purported state-law duty is impossible.

Mensing and Bartlett involved generic drugs. But as Bartlett noted, the regulation prohibiting “major changes” in approved drugs without prior FDA approval, 21 C.F.R. § 314.70(b), applies to all FDA-approved drugs “whether generic or brand-name.” 570 U.S. at 477.

The First Circuit took that observation seriously. Gustavsen addressed claims that targeted “both brand name and generic prescription eye drops.” 903 F.3d at 4. Asserting claims under state law, the plaintiffs claimed that they had been harmed both economically and physically by eye-drop dispensers that dispensed supposedly larger-than-necessary drops. According to the plaintiffs, state-law required the manufacturers to redesign their dispensers so that they dispensed smaller drops. The First Circuit concluded that federal law preempted the plaintiffs’ claims against all of the manufacturers—both generic and branded—because redesigning the dispensers would constitute a “major change” under 21 C.F.R. § 314.70(b) and “major changes” are not permitted without prior FDA approval. In other words, neither the generic manufacturers nor the branded manufacturers “could ‘unilaterally’ do what state law [purportedly] required.” Mensing, 564 U.S. at 620 (quoting Wyeth v. Levine, 555 U.S. 555, 573 (2009)). As a result, state law conflicted with federal law and the plaintiffs’ state-law claims were preempted.

In the course of reaching that conclusion, Gustavsen had to determine what constitutes a “major change” within the meaning of 21 C.F.R. § 314.70(b), which provides that “major changes” require prior FDA approval.

The regulation’s first subdivision, § 314.70(b)(1), provides that FDA approval is required for “any change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.” The regulation’s second subdivision, § 314.70(b)(2), states that “[t]hese changes include, but are not limited to” various categories of enumerated changes. The question for the First Circuit was whether the phrase “[t]hese changes include” refers to the particular changes identified in § 314.70(b)(1) or whether it instead refers to “major changes” generally. If the phrase “[t]hese changes includes” refers to the particular changes identified in § 314.70(b)(1), then the categories of changes listed in § 314.70(b)(2) are merely subcategories of those listed in § 314.70(b)(1), and any particular change would constitute a “major change” only if it has “a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.” By contrast, if the phrase “[t]hese changes include” refers to “major changes” generally, then any particular change is a “major change,” whether or not it had “a substantial potential to have an adverse effect” on the enumerated attributes, so long as it falls into a category of change listed in § 314.70(b)(2).

The First Circuit held that the phrase refers to “major changes” generally. The practical consequence of that holding is that a larger range of changes constitute “major changes” that require prior FDA approval, and thus a larger range of purported state-law claims are preempted by federal law.

The First Circuit gave three reasons for its reading of 21 C.F.R. § 314.70(b). First, as a textual matter, the court thought it “unlikely that the ‘changes’” enumerated “in (b)(2) are a subcategory of the changes in (b)(1)” given that they are identified under a distinct “heading of the same level as the broad definition in section (b)(1).” Second, if the changes enumerated in (b)(2) were merely examples of changes identified in (b)(1), “then whether a change is major or moderate,” and thus whether it requires prior FDA approval, “would depend in every case on a separate determination of the qualitative magnitude of the change,” which was something that the Supreme Court had never required and the First Circuit implied would be unworkable. Third, the First Circuit found that several of the changes listed in (b)(2) “do not map easily onto the types of changes identified in (b)(1).” On these bases, the court “conclude[d] that, if a change fits under any of the categories listed in section (b)(2), that change necessarily constitutes a ‘major’ change requiring FDA pre-approval.” Gustavsen, 903 F.3d at 10–11.

So, the upshot of the First Circuit’s decision in Gustavsen is that any change listed in either § 314.70(b)(1) or § 314.70(b)(2) constitutes a “major change” for purposes of § 314.70(b); and that any state-law claim that would require a “major change” in a pharmaceutical product is impliedly preempted by federal law, whether that product is a branded product or a generic product.

That brings us (finally, our patient readers might think) to the Second Circuit’s recent decision in Ignacuinos, which involved state-law claims targeting a brand name metered-dose inhaler used to treat chronic obstructive pulmonary disease. According to the plaintiffs, the inhaler’s label said that the inhaler would deliver 120 doses when in fact it delivered far few doses. Based on this allegation, the plaintiffs asserted design- and manufacturing-defect claims under state law.

The brand name defendant argued that the plaintiffs’ claims were impliedly preempted because 21 C.F.R. § 314.70(b) prevented it from changing the inhaler’s design or manufacturing methods without prior FDA approval. The Second Circuit, agreed and affirmed the dismissal of the plaintiffs’ claims.

Quoting Gustavsen, the Second Circuit “agree[d] … that ‘if a change fits under any of the categories listed in section (b)(2), that change necessarily constitutes a “major” change requiring FDA pre-approval,” regardless of whether the defendant has shown a substantial potential for an adverse effect.” 2021 WL 3438355, at *2. Accordingly, the Second Circuit “conclude[d] that the plaintiffs’ state law design and manufacturing defect claims [we]re preempted to the extent that they would require any change listed in § 314.70(b)(2).”

The court went on to find that the plaintiffs’ claims would in fact require such changes. The defendant manufacturer, said the court, could not have “unilaterally changed the design of the inhaler to release a different amount of medication per puff” because “Section 314.70(b)(2)(vi) provides that any modification to ‘a drug product container closure system that controls the drug product delivered to a patient’ qualifies as a major change.” 2021 WL 3438355, at *3. And the manufacturer could not have “unilaterally increased the amount of liquid … medication in each [inhaler] cartridge” because “Section 314.70(b)(2)(i)’s list of ‘major changes’ includes ‘changes in the qualitative or quantitative formulation of the drug product.’” Id. at *4.

So, like the First Circuit before it, the Second Circuit has held that any change listed in 21 C.F.R. § 314.70(b)(2) constitutes a “major change” that requires prior FDA approval, and that any state-law claim that would require such a change is impliedly preempted, whether the pharmaceutical product at issue is a generic drug or a branded drug.

That’s a big deal.

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If you are one of our readers who fall into the over 50 demographic, we are going to assume that in your head you read the title of today’s post in John Houseman’s voice and you tagged it with “they earned it.”  That’s because you were alive in the early 1980s when if you wanted to watch TV, you had to watch commercials.  And John Houseman’s Smith Barney commercial is a classic.  If you are also asking who John Houseman is, then we have to assume you have never seen the Paper Chase and to that we say, “you come here with a skull full of mush.”  (again, in Houseman’s voice).

But we digress as we sometimes do.    Instead, we will recite the facts of Kendrick v. Wright Medical Technology, 2021 WL 3526663 (E.D. Ark. Aug. 10, 2021) and try to “fill the room with [our] intelligence.”  Defendant manufactures a knee replacement system.  It is a multi-component system that also involves the use of cement.  Id. at *1.  In the ten years the system has been on the market, defendant was aware of only two incidents where the femoral components broke after implant.  Mr. Kendrick’s was one of them.  Kendrick underwent knee replacement surgery using defendant’s device in 2011.  Approximately four years later plaintiff began experiencing pain which led to a revision surgery at which time the broken femoral component was discovered.  Id.  The surgery also revealed osteolysis behind the femoral component.  All experts in the case agree that osteolysis is a phenomenon that causes “empty spaces” at the bone-implant interface.  In this case, defendant’s expert opined that those empty spaces were caused by poor cement penetration which caused the cement to crack and eventually lead to the osteolysis.  Defendant’s experts also opined that the osteolysis is what in turn caused the femoral component to suffer a fatigue fracture.  Id. at *2.   Defendant also presented expert evidence that the device “met all manufacturing specifications” and was not designed or manufactured in a defective manner.  Id.  Plaintiff’s expert for the most part agreed with the defense experts.  Id.   Finally, the device was accompanied by Instructions for Use (“IFU”) that included a warning of the risk of “osteolysis and component fracture.”  Id. at *3.  Plaintiff’s surgeon testified that he never read the IFU, but that osteolysis is a general risk known to him.  Id.

On plaintiff’s manufacturing and design defect claims, it was undisputed that the device failed “but that doesn’t get Mr. Kendrick over the summary judgment hill.”  Id. at *4.  To prove a defect, plaintiff needs evidence “tending to show that the defect existed before the accident.”  Id. Plaintiff “has not even suggested” the presence of a defect or what the defect might be.  Id. Therefore, plaintiff’s only other recourse is to rely on res ipsa loquitur – asking the jury to infer a defect from the failure of the device.  However, under this theory plaintiff must “negate other possible causes of the failure of the product not attributable to the defendant.”  Id.  But it was undisputed that the osteolysis left the femoral component unsupported and therefore was a possible cause of the fracture.  Instead of negating that cause, plaintiff argued “a rational juror could reasonably infer . . .  that a knee implant which effectively destroys itself . . . is a defective condition.”  Id. at *5.  But there is no record evidence to support plaintiff’s conclusion that the device “destroyed itself” which is what “set[s] off the speculative chain of events [plaintiff] suggests.”  Id.  Since “speculation falls far short of dispelling other causes,” defendant was entitled to summary judgment on manufacturing and design defect.

As to failure to warn, first the court ruled that the Arkansas Supreme Court would apply the learned intermediary doctrine to prescription medical devices for all the reasons it adopted it for prescription drugs.  Id. at *6.  Therefore, defendant’s duty to provide an adequate warning of the risks ran to plaintiff’s surgeon.  Because defendant’s IFU warned of the very risks plaintiff encountered, defendant’s warnings were adequate as a matter of law.  Id. at *7.  But even if the court found the warnings deficient in some way, plaintiff’s claim would still fail for lack of proximate causation.  Plaintiff’s surgeon never read the warnings, so any inadequacy in the warning could not have been the cause of plaintiff’s injury.  Further, his surgeon testified he was independently aware of the risks which also cuts off any causal link.

Finally, plaintiff’s implied warranty claim also required proof of a product defect and therefore failed for the same reasons the manufacturing and design claims failed.  Id.  And, plaintiff’s negligence claims failed because defendant presented expert evidence that it manufactured a “well-functioning” device that was appropriately evaluated for safety and effectiveness and in compliance with FDA regulations.  Id. at *8.  Plaintiff’s experts did not refute this evidence; therefore, plaintiff did not raise a triable issue on negligence.  Relying on the device failure alone was again insufficient to sustain his claim.  Id.

Now, if you weren’t with us in our opening pop culture reference, maybe you’ll like this one better.  Plaintiff’s first name was Billy Ray.  Since we were already thinking of the financial market with Smith Barney, Billy Ray led us directly to Trading Places.  They may not have made their money the old-fashioned way, but they did it with style.

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Back in May, we discussed the latest amendments proposed by the Advisory Committee on Civil Rules to Fed. R. Evid. 702.  These amendments, while not changing the substance of Rule 702’s standards for admission of expert testimony – helpfulness, factual basis, reliability – are intended to reinforce other aspects of the Rule.  These changes are:  (1) requiring the proponent of the expert to meet its burden of proof, and (2) that expert opinions must not only apply methods that are “reliable,” in the abstract, but must reliably apply those methods in the context of the facts of each case in which they are offered.

Under the current rule, the Advisory Committee has concluded, too many judges are failing to exercise their gatekeeping function, and instead have been kicking the can, particularly on reliability, down the road to the jury.  That, the rules will now state, is error:

But many courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology, are questions of weight and not admissibility.  These rulings are an incorrect application of Rules 702 and 104(a). . . .  [E]mphasizing the preponderance standard in Rule 702 specifically was made necessary by the courts that have failed to correctly apply it when applying the reliability requirements of that Rule. . . .  [Rule 702] does not mean, as certain courts have held, that arguments about the sufficiency of an expert’s basis always go to weight and not admissibility.

Proposed Committee Note (emphasis added).

It’s about time.

Despite the existing language of Rule 702, we have misguided holdings like this:  “As a general rule, the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination.”  United States v. Finch, 630 F.3d 1057, 1062 (8th Cir. 2011).  How did Finch get there?  By blindly quoting a 2009 case that in turn quoted a 1997 case.  Id.  Whatever was true in 1997 was error by 2011 (and even worse for the 17 cases since that have since cited this headnote in Finch) because it totally ignores the 2000 overhaul of Rule 702 that “respon[ded]” to the recognition in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and subsequent cases that federal district judges have “the responsibility of acting as gatekeepers to exclude unreliable expert testimony.”

The [2000] amendment affirms the trial court’s role as gatekeeper and provides some general standards that the trial court must use to assess the reliability and helpfulness of proffered expert testimony. . . .  [T]he Rule as amended provides that all types of expert testimony present questions of admissibility for the trial court in deciding whether the evidence is reliable and helpful.  Consequently, [for] the admissibility of all expert testimony . . . the proponent has the burden of establishing that the pertinent admissibility requirements are met by a preponderance of the evidence.

2000 Committee Note.

There’s plenty more adverse, and simply wrong, Rule 702 caselaw involving admissibility of expert testimony created by courts that continue blindly following pre-2000 precedent.  First and foremost is the obsolete judicial chestnut about expert admissibility:  that exclusion of expert testimony is supposedly “the exception rather than the rule.”  That also comes, albeit indirectly, from pre-2000 precedent.  The 2000 Committee Note included a survey of sorts of that precedent, stating that “[a] review of the caselaw” revealed less than vigorous gatekeeping – that exclusion was the “the exception rather than the rule,” and the 2000 amendments were the Committee’s first attempt to do something about that.

Instead, courts intent upon avoiding their gatekeeping responsibilities have taken that line completely out of context – and converted it into a value judgment:  that lassitude was how things were supposed to be.  For more details, see Mickus, “Gatekeeping Reorientation:  Amend Rule 702 To Correct Judicial Misunderstandings about Expert Evidence” (May 2020), available here, and “Floodgates Not Gatekeeping,” available here.  This approach was most emphatically not what the Committee intended, hence the current amendments.

We’re not going to duplicate all that research, which the Advisory Committee has already reviewed and quite evidently agreed with, but a quickie search of cases for 2021 only shows why these latest amendments are sorely needed.  A search for “exception rather than the rule” in the same paragraph as “702” or “Daubert” yielded no fewer than seventy-five cases in the federal courts – including the egregious Moore v. Intuitive Surgical, Inc., 995 F.3d 839 (11th Cir. 2021), in which the appellate court found an abuse of discretion in excluding a “differential etiology” about an aspect of robotic surgery despite its being offered by an “expert” who (while an experienced surgeon) had never actually performed a robotic surgery in his life.  Id. at 853.  That’s 75 cases misciting the Committee’s 2000 note in less than eight months.  No wonder the Committee has acted.

Another form of Rule 702 abuse is when courts ignore the burden of proof added to Rule 702 in 2000 and in favor of a non-existent “presumption of admissibility.”  We ran another quickie search, and for 2021 alone, found three such cases:  American Dairy Queen Corp. v. W.B. Mason Co., ___ F. Supp.3d ___, 2021 WL 2382313, at *24 (D. Minn. June 10, 2021) Scott v. Dyno Nobel, Inc., 2021 WL 1750238, at *3 (E.D. Mo. May 4, 2021); Cleaver v. Union Pacific Railroad Co., 2021 WL 75259, at *5 (D. Neb. Jan. 7, 2021).  It’s probably not a coincidence that all of these courts are in the Eighth Circuit.

We can only hope that the new amendments, assuming they are enacted, are more effective in enforcing Rule 702’s gatekeeping requirements than were the 2000 amendments.

Our defense-minded readers can help.  What’s happens next is the public part of the rules amendment process.  Public comments on the amendments opened on August 6, and will continue until February 16, 2022.  The Committee’s Preliminary Draft, available here, provides instructions (at the beginning) on how to file a comment.  The material on the Rule 702 amendments is on pp. 308-32.  We encourage our audience (or their firms) to file a comment – no form letters, please – that can include specific instances you have encountered where courts have avoided or evaded the expert admissibility standards that Rule 702 is designed to enforce.

Beyond that – defense counsel should simply stop saying “Daubert” and start using “Rule 702” as the preferred terminology.  There are multiple reasons for this, and they’re discussed in more depth on the new Lawyers for Civil Justice Don’t Say Daubert website.  We at the Blog are as guilty as anyone for using terms like “Daubert motion” or “Daubert ruling.”  We’ve started to make amends, such as replacing what had been a “Daubert” tag for posts with “Rule 702” and changing the titles of dozens of posts.

Why?

Basically, so we’re not undercutting our own arguments on expert admissibility.  The decision Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), while justifiably viewed as seminal on the gatekeeping requirement, is hardly the last word on admissibility standards.  That’s what Rule 702 is for.  On that issue Daubert is, to use a technical term, mushy as all get out.  It provides a bunch of overlapping and non-exclusive “factors” that Rule 702 has subsequently honed and limited.  Language in Daubert about the “liberal thrust” of the federal rules, 509 U.S. at 588, is – like the 2000 comment discussed above – subject to out-of-context abuse, since that statement was a comparison to the prior, narrowly focused Frye standard.

Loose use of “Daubert” conveys to courts that it’s okay for them to rely on pre-2000 expert admissibility standards, since Daubert itself predates the current structure of Rule 702.  That lets erroneously lax pre-2000 “tests” continue:

  • “Questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility.”  This statement, is facially contrary to Rule 702(b)’s requirement that courts decide whether “the testimony is based on sufficient facts or data.”  This phrase appears in 492 federal cases dated after 2000, and originated in Viterbo v. Dow Chemical Co., 826 F.2d 420, 422 (5th Cir. 1987).
  • “The factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility.”  This statement, is likewise facially contrary to Rule 702(b)’s requirement that courts decide whether “the testimony is based on sufficient facts or data.”  This phrase appears in 551 federal cases dated after 2000, and originated in Loudermill v. Dow Chemical Co., 863 F.2d 566, 570 (8th Cir. 1988).
  • “Soundness of the factual underpinnings of the expert’s analysis and the correctness of the expert’s conclusions based on that analysis are factual matters to be determined by the trier of fact.”  This phrase appears in 197 federal cases dated after 2000, and originated in Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir. 2000), which was decided before the 2000 amendment to Rule 702 became effective on December 1, 2000.

All these statements are simply wrong, given the express terms of Rule 702.  Courts are not allowed to ignore the the Federal Rules:

[O]f overriding importance, courts must be mindful that [any] Rule as now composed sets the requirements they are bound to enforce.  Federal Rules take effect after an extensive deliberative process involving many reviewers:  a Rules Advisory Committee, public commenters, the Judicial Conference, this Court, the Congress.  The text of a rule thus proposed and reviewed limits judicial inventiveness.  Courts are not free to amend a rule outside the process Congress ordered.

Amchem Products, Inc. v. Windsor, 521 U.S. 591, 620 (1997).

In the expert admissibility context, the older the case, the less likely it is to have applied rigorous gatekeeping.  Thus, colloquial use of “Daubert” and rote reliance on pre-2000 expert admissibility caselaw does not help our clients.

These three instances of outdated, anti-gatekeeping language alone have affected over 1,000 expert admissibility decisions, ostensibly being made under Rule 702.  It’s not hard to check these things, either – just grab the verbatim quote of any dodgy language that the other side offers, put quotation marks around it, and throw it into Lexis or Westlaw.  Arrange the results by date and see when the oldest use occurred.  Then call out the other side for misleading the court with pre-2000 standards, often laundered through the opinions of more recent courts that themselves were snookered by similar ploys.

That, and get these Rule 702 amendments enacted as soon as possible.

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We reported two weeks ago on the poorly conceived and ill-fated attempt by students to enjoin a public university from mandating COVID-19 vaccines.  There simply is no fundamental right under the Constitution to refuse vaccination, which has been firmly established for more than 100 years.  Now the Seventh Circuit has agreed.

Let’s be candid about what this lawsuit and others like it are:  They are overtly political attempts to use the courts to promote an anti-vax agenda, not good faith attempts to secure rights guaranteed by the Constitution.  We explained the cynicism behind the movement and its utter lack of legal support in some detail here.

That, however, has not stopped the lawsuits.  The Wall Street Journal reports that students have sued public universities in Indiana, Connecticut, California, and Massachusetts.  There may be more, but none has succeeded.  In the Indiana University case on which we reported two weeks ago, the plaintiffs appealed to the Seventh Circuit, which has already denied a motion for injunction pending appeal.  Klaassen v. Trustees of Indiana Univ., No. 21-2326, 2021 WL 3281209 (7th Cir. Aug. 2, 2021).  Moreover, the Seventh Circuit’s order denying the injunction, authored by Judge Easterbrook, does not hold back in condemning the plaintiff’s case on the merits:

Given Jacobson v. Massachusetts, 197 U.S. 11 (1905), which holds that a state may require all members of the public to be vaccinated against smallpox, there can’t be a constitutional problem with vaccination against SARS-CoV-2 [aka COVID-19].

Id. at *1.  In so holding, the Seventh Circuit flatly rejected the idea that the plaintiffs have a fundamental right to refuse vaccination.  If anything, this case is “easier than Jacobson.”  First, the university’s mandatory vaccination policy has numerous exceptions, into which seven of the eight plaintiff fall.  Second, Indiana does not require every adult to be vaccinated.  “Vaccination is instead a condition of attending Indiana University.  People who do not want to be vaccinated may go elsewhere.”  Id.

The Seventh Circuit also embraced the public policy that resonated with the district court and, based on our emails, many others:  “Vaccination protects not only the vaccinated persons but also those who come into contact with them, and at a university close contact is inevitable.”  Id.  In other words, the students are not operating in a vacuum.  Far from it, and their recalcitrance inevitably impacts others, not only through the potential spread of disease, but also through imposition of remote learning and other measures that otherwise would not be necessary.

The Seventh Circuit could have stopped there, but Judge Easterbrook gave us this nugget, which is entertaining and persuasive in a very Easterbrookian way:

Other conditions of enrollment are normal and proper.  The First Amendment means that a state cannot tell anyone what to read or write, but a state university may demand that students read things they prefer not to read and write things they prefer not to write.  A student must read what a professor assigns, even if the student deems the books heretical, and must write exams or essays as required.  [Citations omitted]  A student told to analyze the role of nihilism in Dostoevsky’s The Possessed but who submits an essay about Iago’s motivation in Othello will flunk.

If conditions of higher education may include surrendering property [i.e., tuition] and following instructions about what to read and write, it is hard to see a greater problem with medical conditions that help all students remain safe when learning.

Id. at *2.  This discussion of course reflects that the right at issue is the right to a university education, which as any tuition payer (often known as “parents”) can attest, involves a substantial deprivation of property.  The Constitution does not prohibit conditioning a university education on surrendering property, nor does it prohibit conditioning an education on following mandates rationally related to protecting the public health.

Thus, the misguided fight goes on, but still without success.  The plaintiffs in Klaassen applied to the Supreme Court for an emergency injunction earlier this week, and Justice Barrett denied the injunction as we were writing this post.  (You can link to the Supreme Court’s docket and view the application here).  There is no written order; the docket say only “denied,” but we hope and expect that Justice Barrett saw the legal issue as non-controversial as the learned judges who ruled before her.  Notably, the only third-party to seek permission to file an amicus brief in support of the plaintiffs was an advocacy group opposed to mandatory vaccination of all kinds.  Politics.  Always politics.

Photo of Rachel B. Weil

We have news to report.   No, we don’t mean the resignation of New York’s governor, though we can’t say we’ve shed many tears.  And we certainly don’t have much good news about Greece, where we are supposed to be headed in a few weeks.  Between Delta (Greece is now back in the CDC’s “Level Four”)  and the catastrophic fires in Greece and Turkey that have filled the skies over our destination island with dense smoke, Greece is suffering through scary and challenging times, and we are keeping that beautiful country and its people in our thoughts.

Our news is of the first-world professional sort, but it is right in our wheelhouse and has the potential to benefit all of us who represent medical device manufacturers.  (It has the opposite potential, too, but we are in a glass-half-full mood.)   As we lamented a little over a year ago, in a post about a case called Ebert v. C.R. Bard, 2020 WL 2332060 (E.D. Pa. May 11, 2020) (as well as here and here and here and here), Pennsylvania’s federal district courts have spent the past several years in a ludicrous and unnecessary debate.  Courts have split over whether the “unavoidably unsafe product” exception of comment k to Section 402(A) to the Restatement (Second) of Torts, which expressly bars strict liability design defect claims against manufacturers of prescription drugs, also bars those claims against manufacturers of prescription medical devices.  Why is this debate ludicrous and unnecessary?  Because there is no conceivable basis on which to draw a principled distinction between prescription drugs and prescription medical devices for purposes of comment k’s exemption.  Of course comment k bars strict liability claims against device manufacturers.  There is no colorable argument otherwise, and decades of Pennsylvania appellate jurisprudence (stopping short of the Pennsylvania Supreme Court, but stay tuned) agrees with us.

Ebert went the wrong way on the comment k question.  But it went the right way on another disputed issue:  the scope of the Pennsylvania Supreme Court’s 2014 Lance decision, which held, for the first time, that negligent design defect claims are cognizable in prescription drug cases.  (Pennsylvania’s federal district courts broadened the holding to apply to prescription medical devices.) The Ebert court agreed with the defendants that the relevant duty of care is narrow – that manufacturers breach their duty only if they introduce into the marketplace a drug that is too harmful to be used by anyone.  (The plaintiff disagreed, citing language from Lance to the effect that the duty can be viewed as a continuum with breaches of duty possible all along the continuum.)

Last month, we told you that the Third Circuit had certified both questions to the Pennsylvania Supreme Court.  Just last Thursday, the Supreme Court granted review of both questions.  The Order states:

The Court shall consider the following issues:  (1) Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may the plaintiff also prevail on other theories of liability where appropriate? (2) Under Pennsylvania law, are prescription implantable medical devices categorically subject to strict liability, categorically immune from strict liability, or immune from strict liability on a case-by-case basis? If they are immune on a case-by-case basis, what test should a court apply to determine whether a particular device is immune?

We are watching anxiously, cautiously hopeful that the Court will adopt the narrow construction of Lance and will hold that comment k applies across the board to bar strict liability design defect claims against prescription medical device manufacturers.  (Our personal opinion is that applying comment k on a case-by-case basis is of little value, as this analysis nearly always involves fact issues that preclude summary judgment.)  We will let you know as soon as the Court decides the appeal.  We may even attend the argument, if it is “in person,” and we will let you know if we do.  In the meantime, stay safe out there.

Photo of Stephen McConnell

This will be the last post we write for a while, as we are about to head to trial in a product liability case. The plaintiff says that a medical device has caused her to suffer pain and other injuries. What else would you expect? Her case has gotten as far as it has because an expert will come to court and act as a credentialed and highly-paid oath-helper. He will say that the device is, indeed, the culprit. Again, what else would you expect? But we think his opinions lack support and don’t quite get to where they need to go. For that reason, we will keep a copy of Gottlieb v. C.R. Bard, Inc., 2021 U.S. Dist. LEXIS 141280 (E.D. Va. July 31, 2021), near at hand.

Gottlieb was about an implanted IVC filter. (Our case also involves an implant, but not an IVC filter.). The IVC filter fractured and migrated. The plaintiff in Gottlieb alleged that such fracturing/migration of the filter caused her to suffer from anxiety, abdominal pain, chest pain, and shortness of breath. Her complaint included the usual catalogue of causes of action, including negligent design, failure to warn, breach of warranty, and misrepresentation. The plaintiff sought compensatory and punitive damages. The defendant filed a motion for summary judgment, with the primary argument being that the plaintiff could not prove proximate causation.

It is clear under the law of Virginia (and every other place we’ve litigated) that a plaintiff needs a medical expert to establish medical causation. In Gottlieb, the plaintiff had such an expert. The issue was whether that expert said what needed to be said. To be sure, the medical expert pronounced that all of his opinions were held to a reasonable degree of medical certainty. The necessary incantation was uttered. There also does not seem to be any deficiency in the expert’s qualifications. He was a doctor, not a quack. He was apparently even a doctor in the right specialty. So far so good.

The plaintiff medical expert looked at the appropriate medical records. He testified that the IVC filter fractured and migrated just a bit north of the retrieval hook. Okay, then what? Herein lies the problem with the expert’s opinions. His only real opinion regarding the plaintiff’s alleged injuries is that she “will need to have close clinical follow-up.” He does not specifically tie the alleged injuries (anxiety, pain, shortness of breath) to the fractured filter. At most, the expert offered “speculative testimony regarding the potential ramifications of Plaintiff’s filter’s movement” — which the court held was “insufficient.”

Perhaps the plaintiff medical expert in Gottlieb should be congratulated for not overextending. But we doubt that the plaintiff or her lawyers are offering such congratulations, because the testamentary gap prompted the court to grant summary judgment in favor of the defendant: “Here, Plaintiff offers no expert testimony that her IVC filter caused her injuries, and is therefore unable to create a jury issue as to causation. Without any expert testimony that the complications associated with her IVC filter caused her alleged injuries, Plaintiff’s claims must fail.”

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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