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[This post is from the non-Reed Smith side of the blog.]

Today we report on Dickson v. Dexcom, Inc, 2024 WL 4291511 (W.D. La. 2024), an important medical-device preemption case that started with a doctrinal bang but ended on a factual whimper.

Committed to nationally uniform standards based on good science, we believe that the FDA rather than lay juries should determine how medical devices are designed and labeled. Fortunately, our policy preference is enshrined in law: 21 U.S.C. § 360k(a) prohibits states (and juries applying state tort law) from imposing safety or efficacy requirements on medical devices that are “different from, or in addition to,” those imposed by the FDA. Unfortunately, many courts—led astray by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)—have unduly limited § 360k(a)’s preemptive scope, holding that it applies only to Class III medical devices that have received premarket approval (or an investigational-device exemption) from the FDA.

Dissatisfied with the judicially imposed limitation on § 360k(a)’s scope, we were pleased when Dickson v. Dexcom, Inc, 2024 WL 2846055 (W.D. La. 2024), correctly held that § 360k(a) preempts claims challenging the safety and effectiveness of a Class II device whose sale was authorized by the FDA through the de novo classification process. As we reported at the time, the decision was very good insofar as it squarely recognized that § 360k(a)’s preemptive shield covers such devices.

Still, we were troubled by the court having granted the plaintiff leave to replead her failure-to-warn claim. Without explicitly saying so, the court held that the claim could survive preemption if the plaintiff alleged facts that, if true, would have allowed the defendant manufacturer to unilaterally the revise device’s labeling under the FDA’s changes-being-effected (CBE) regulation codified at 21 C.F.R. § 814.39(d). Specifically, the court concluded that the claim might not be preempted if the plaintiff adequately alleged the existence of “newly acquired information,” which is a necessary precondition for changes under that provision. 2024 WL 3417392, at *8.

As we explained at the time, the hypothesized loophole to express preemption—which the court derived from inapposite pharmaceutical cases addressing implied preemption—is foreclosed as a matter of law. The only labels that may be revised under the CBE regulation are those for Class III medical devices that have received premarket approval; the regulation does not allow a manufacturer to revise the labeling of a device that received de novo classification. But even “assum[ing] for the sake of argument that there might have been some way for” the defendant to have invoked the CBE regulation (Dickson, 2024 WL 3417392, at *8), it would not save the plaintiff’s failure-to-warn claim from express preemption because the regulation does not require a manufacturer to unilaterally revise device labeling based on newly acquired information and any state-law requirement that it do so would be “different from, or in addition to,” the federal requirements and therefore barred by 21 U.S.C. § 360k(a).

When recounting Dickson, we expressed the hope that the court would correct its error if the plaintiff chose to amend her complaint to include purportedly sufficient allegations of “newly acquired information.”

Alas, that did not happen.

Ruling on the defendant’s motion to dismiss the plaintiff’s amended complaint, the court dismissed her failure-to-warn claim as preempted but on factual rather than legal grounds, concluding that “[e]ven if plaintiff could show a mechanism like the CBE regulation requiring [the manufacturer] to independently reevaluate and amend its label, she has twice failed to show sufficient ‘newly acquired information’ to trigger any relevant change to the existing warnings.” Dickson, 2024 WL 4291511, at *4. In reaching that conclusion, the court correctly recognized that adverse-event reports by themselves do not constitute such information. We welcome that. But we sure wish that the court had also recognized that § 360k(a) categorically bars claims based on a manufacturer’s purported ability to revise a device’s labeling under the CBE regulation.

So, at the end of the day, the Dickson duology represents a significant step forward and a minor step back. Let us hope that future courts apply § 360k(a) to claims implicating devices that received de novo classification but do so with the understanding that the CBE regulation cannot save otherwise preempted failure-to-warn claims.

In the meantime, thanks to friend-of-the-blog P.J. Cosgrove of UB Greensfelder LLP for bringing Dickson to our attention.

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In re Deepwater Horizon Belo Cases, — F.4th –, 2024 WL 4522690 (11th Cir. Oct. 18, 2024), is not a drug or device case. It is the Eleventh Circuit’s review of the Northern District of Florida’s exclusion of the plaintiffs’ general causation experts in a toxic tort exposure case arising from the clean-up of the Deepwater Horizon oil spill.  But the issues are identical to Rule 702 issues we face in our cases.

In the years that followed the oil spill, numerous personal injury lawsuits were filed by clean-up workers and local residents alleging conditions such as chronic sinusitis.  The cases were consolidated and a settlement was reached in 2012 dividing the claims into two categories.  Those diagnosed before the cutoff date could submit a claim for fixed compensation from the settlement pot.  Those diagnosed after the cutoff date could file individual tort suits.  Thousands of plaintiffs filed “backend” suits, several hundred of which were transferred to the Northern District of Florida.  To save time and expense, the court bifurcated the litigation to address general causation first because “the medical community does not widely accept[ ] that oil, dispersants, or any chemicals associated with them can cause common conditions like chronic sinusitis.”  Id. at *3.

In a 79-page report and recommendation by the magistrate judge that was adopted by the trial judge, the court excluded plaintiffs’ general causation experts on several grounds chief among them being that neither expert “identified a minimum level of exposure at which crude oil, its dispersants, or the chemicals in them are hazardous to human beings” – a threshold test.  Id. at *4. Absent expert evidence establishing general causation, the court went on to grant defendant’s motion for summary judgment. 

On appeal the Eleventh Circuit found no abuse of discretion by the trial court’s exclusion of the expert testimony and upheld both that decision and the subsequent entry of summary judgment.  The opinion starts by explaining general causation–“whether an agent increases the incidence of disease in a group”—and the types of evidence needed to prove it–epidemiological evidence, dose-response relationship, and background risk of disease.  Id. at *1-2.  We recommend the court’s “primer” on all three, but for today’s purposes we focus on the dose-response relationship.  Because “all substances can potentially be toxic,” neither the scientific community nor Rule 702 accepts a no-threshold exposure level.  The “single most important factor” in establishing general causation is evidence of what dose or level of exposure is associated with an increased risk of a specific adverse event.  Id. at *2. 

Plaintiffs argued that establishing the level at which exposure can cause the harm alleged—the threshold level—was relevant to specific causation only.  But that files directly in the face of Eleventh Circuit precedent dating back to McClain v. Metabolife International, Inc., 401 F.3d 1233 (11th Cir. 2005), in which the court ruled that a toxic-tort plaintiff “must demonstrate the levels of exposure” to the alleged toxin “that are hazardous to human beings generally.”  Id. at 1241 (emphasis added) (excluding expert who did not opine about the level of exposure at which the ephedrine/caffeine in defendant’s product causes harm).  Establishing the “threshold level” is the “basic methodology that scientists use to determine causation,” and therefore critical to admissibility under Rule 702.  Therefore,

[t]he district court did not abuse its discretion when it required the experts to identify a “toxin” and prove it “[was] harmful above a particular threshold” and excluded them because they failed to do so. Instead, it applied general-causation principles drawn directly from [11th Circuit] precedents, aligned with those of other circuits.

In re Deepwater Horizon, at *6. 

Plaintiffs’ attempt to shift “threshold level” evidence to specific causation confuses the issue.  Only after the harmful level is established as to the general population, does the analysis move to whether an individual plaintiff was exposed to that level, i.e. specific causation.  In other words,

[a] plaintiff’s exposure to the threshold dose of a toxin is relevant to specific causation. Yet we also ask, under our general-causation framework, whether a harmful level of the toxin exists in the first place.

Id.

While the failure to establish the threshold harmful level was sufficient by itself to exclude plaintiffs’ experts, the Eleventh Circuit found the district court had a myriad of other reasons to support its decision.  For example, plaintiffs’ experts failed to identify a statistically significant association in the literature; relied on studies addressing acute rather chronic conditions or different conditions (asthma) altogether; ignored limitations and inconsistencies in the relied on studies; and in their epidemiological analysis failed to adequately address the Bradford Hill factors (one expert only discussed three of the nine factors).  Id. at *7.  Rather than abusing its discretion, the district court had ample, well-supported reasons for excluding the experts and granting summary judgment.

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The Drug and Device Law Blog is deliberately apolitical.  Our purpose is to support the defense of prescription medical product liability litigation, and we recognize that the political views of our intended audience undoubtedly vary widely.

But one of the foundational grounds of our defense efforts is that the FDA, in its approval and subsequent regulation of prescription medical products, does so through skilled experts impartially evaluating well-conducted research and sufficiently supported facts.  The agency’s adherence to the scientific method and scientific principles is essential to our clients as they develop, and seek regulatory approval for, new prescription medical products, as well as changes to existing labeling, designs, and manufacturing processes.  In litigation, the FDA’s adherence to the scientific method and scientific principles is the underpinning of our clients’ two most powerful defenses – preemption and Rule 702/expert admissibility.  If the FDA (and other federal agencies such as the CDC, NIH, and ACIP) ever abandoned, or were perceived to have abandoned, the scientific method in its decision-making, both regulatory and litigation chaos quite likely would result.

That’s why we are disturbed by indications that anti-vaccine crusader and all-around science denier Robert Kennedy, Jr. might be given authority over the FDA – and allowed to “go wild” over “health care” and “medicines.”  Here is a video link to a recent Trump speech, and here is our transcript limited to the relevant statements:

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Federal officer jurisdiction is the quiet middle child of the federal jurisdiction family.  We all came out of law school fully versed in federal question jurisdiction and diversity jurisdiction (and we also vividly recall our civil procedure professor using Wyoming and Colorado for all his hypotheticals on diversity of citizenship because those were the only two states he could draw).  But federal officer jurisdiction is a real player in the federal jurisdiction sandbox, and it should not be overlooked. 

The First Circuit surely did not overlook it, and the result is federal officer jurisdiction over an insulin pricing dispute and a very strong opinion rejecting the plaintiff’s attempt to “disclaim” relief relating to any federal program.  The case is Puerto Rico v. Express Scripts, Inc., No. 23-1612, 2024 U.S. App. LEXIS (1st Cir. Oct. 18, 2024), where the Commonwealth of Puerto Rico sued a number of pharmacy benefit managers on behalf of residents of the Commonwealth to recover for allegedly inflating insulin prices.  As the court described, pharmacy benefit managers (or PBMs) act as “middlemen” between health care plans, pharmacies, and pharmaceutical manufacturers.  In that role, PBMs contract with their client health plans to administer prescription drug benefits, manage drug costs, and negotiate rebates and discounts from manufacturers.  Id. at *4-*5.  At the core of the plaintiff’s claim is its unproven allegation that the PBMs inflated prices through their rebate negotiations with drug manufacturers. 

For federal jurisdiction, the key fact here is that at least one PBM defendant performed services for carriers offering benefits to federal employees under the Federal Employees Health Benefits Act.  That is to say, when federal employees residing in Puerto Rico purchased insulin using benefits under their FEHBA plans, they were purchasing drugs under terms negotiated by the defendant. 

Moreover—and this is the really key fact—when negotiating with manufacturers, the defendant did not distinguish between FEHBA clients and non-FEHBA clients.  When a PBM negotiated with a manufacturer, it was one set of negotiations on behalf of all its clients, making the work “indivisible.” 

The plaintiff clearly knew that removal to federal court was a risk, so it preemptively included in its complaint an express “disclaimer” of any federal-related claim: 

The [Commonwealth] is not seeking relief relating to any federal program (e.g., Medicaid, Medicare) or any contract related to a federal program.  Moreover, the [Commonwealth’s] claims do not arise out of a written contract, but rather are based on the larger unfair and deceptive scheme that violates the Fair Competition Act and increased prices . . . for Puerto Rico Consumers.

Id. at *8.  The district court accepted this disclaimer and remanded the case, but the First Circuit reversed, holding that the defendants properly removed the case, and that the disclaimer had no effect. 

To review, the U.S. Code permits removal of an action to federal court if the defendant “is an officer (or any person acting under that officer) of the United States” and is sued “in an official or individual capacity, for or relating to any act under color of such office.”  Id. at *14-*15 (citing 28 U.S.C. § 1442(a)(1)).  This is federal officer jurisdiction, and it requires three elements: (1) that the defendant was acting under a federal officer’s authority; (2) that the charged conduct was carried out for or relating to the asserted official authority; and (3) that the defendant will assert a colorable federal defense to the suit.  Id. at *16-*17.

Here, when the defendant negotiated drug rebates and drug pricing on behalf of federal employees covered by FEHBA plans, it was acting under federal authority and its conduct was related to that authority.  The defendant also had a colorable federal defense:  FEHBA includes an express preemption provision, which the defendant had a right to present in federal court.  Id. at *25-*27.  That is a rock-solid basis for federal officer jurisdiction. 

But what about the plaintiff’s attempted “disclaimer”?  Well, it turns out there are two kinds of disclaimers.  First, there is an express disclaimer of claims that could serve as the grounds for removal; and second, there is mere “artful pleading” for purposes of circumventing federal officer jurisdiction.  Mere artful pleading is never credited.  Id. at *21.  By comparison, an express disclaimer can be effective, but it “must eliminate any basis for federal officer removal so that, upon remand, there is no possibility that a state court would have to determine whether a defendant acted under a federal officer’s authority.”  Id. at *19-*20 (emphasis inoriginal). 

That is where the plaintiff’s express disclaimer failed.  While the plaintiff attempted to disclaim any relief relating to any federal program, including FEHBA, the defendant negotiates for rebates jointly for all its clients—including FEHBA-based carriers.  Moreover, those negotiations lead to rebate agreements that do not distinguish between FEHBA and non-FEHBA plans.  The plans and their beneficiaries all get the same rebates. 

As a result, even though the plaintiff attempted to disclaim “federal” relief, it was still attempting to recover based on the defendant’s “official acts” because the charged conduct was all the same—or “indivisible.”  The First Circuit emphasized three points.  First, as mentioned, by targeting the defendant’s rebate negotiations, the plaintiff was necessarily targeting acts under a federal officer because the defendant negotiated for FEHBA and non-FEHBA plans simultaneously.  Second, because those negotiations could not be “disassembled,” crediting the disclaimer would foreclose the defendant’s right to have a federal court determine its express preemption defense.  Third, crediting the disclaimer would undercut § 1442(a)(1)’s requirement that federal courts determine whether a defendant acted under a federal officer’s authority.  Id. at *28-*30.

As you can see, the indivisible nature of the defendant’s negotiations on behalf of all its clients was dispositive.  As the First Circuit put it, “[Defendant] claims that it negotiates for FEHBA and non-FEHBA plans in one fell swoop.  Given this purported indivisibility, . . . the Commonwealth could recover in the [Puerto Rico] Court of First Instance for [Defendant’s] acts under a federal officer’s authority.  That would deprive [Defendant] of the federal forum to which it is entitled.”  Id. at *30-*31.  We have never known “in one fell swoop” to be a legal term of art, but we’ll take it. 

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Almost a year ago (how time flies!), we brought you our first Rico Madness post, regarding the cert petition in Medical Marijuana, Inc. v. Horn, and promised to keep you updated if the Supreme Court took the case.  Well, they did and we are.

In our prior post, we noted that we are not fans of civil RICO, and object to its misuse by the other side in non-racketeering contexts, its treble damages and attorneys’ fees provisions, and its nationwide personal jurisdiction and venue provisions, 18 U.S.C. 1965(a)-(d). 

But our issue in these RICO madness posts involves the meaning of RICO’s statement that “Any person injured in [their] business or property” by a predicate act “shall recover threefold the damages” sustained plus attorneys’ fees.  18 U.S.C. § 1964(c). 

The Supreme Court previously held that “injured in [their] business or property” “exclud[es] … personal injuries.”  RJR Nabisco, Inc. v. Eur. Cmty., 579 U.S. 325, 350 (2016).  And one would think that RJR Nabisco pretty much put the end to plaintiffs trying to recovery traditional personal injury damages—think lost wages or medical expenses—in civil RICO actions, but one would be wrong. 

In Horn v. Med. Marijuana, Inc., 80 F.4th 130 (2d Cir. 2023), the Second Circuit joined the Ninth Circuit in concluding that what we see all the time as traditional personal injury damages—lost wages and medical expenses—are in fact “business or property” recoverable under civil RICO.  See Diaz v. Gates, 420 F.3d 897, 900 (9th Cir. 2005) (en banc). 

Because, fortunately, other circuits disagree with the Ninth and the Second, the meaning of “business or property” under civil RICO has returned to the high court.  See Jackson v. Sedgwick Claims Mgmt. Servs., 731 F.3d 556 (6th Cir. 2013) (en banc); Evans v. City of Chicago, 434 F.3d 916, 926-27 (7th Cir. 2006), overruled on other grounds by Hill v. Tangherlini, 724 F.3d 965, 967 n.1 (7th Cir. 2013); and Grogan v. Platt, 835 F.2d 844, 848 (11th Cir. 1988).  

According to their merits brief, the Plaintiff/Respondent in Medical Marijuana has taken the position that civil RICO’s “business or property” provision authorizes treble damages for any “harm” for which the plaintiff can “produce receipts, like lost profits, increased expenditures, bills, lost wages, and the like.”  Under their position, civil RICO’s exclusion of personal injuries only keeps out unfixed “nonpecuniary damages,” like pain and suffering.  In other words, plaintiff’s view is that lost wages are not a measure of damages that arise from a personal injury, they are a stand-alone “business or property” injury in their own right. 

Which brings us to October 15, 2024, when the Supreme Court held oral argument in this case and heard from two formidable advocates:  Lisa Blatt of Williams & Connolly for the Defendants/Petitioners, and Easha Anand of the Stanford Supreme Court Litigation Clinic for the Plaintiff/Respondent.  You can listen to the argument or read the transcript at https://www.oyez.org/cases/2024/23-365.

The argument brought up several interesting, and some concerning, questions from the bench. 

One set of questions, raised most often by Justice Kentanj Brown Jackson, probed whether this particular case is the right vehicle for the Supreme Court to address the question presented.  These questions noted that the Defendants/Petitioners framed the claim as one for personal injury but the case was in fact unlike the prototypical product liability case we see, where a plaintiff suffers physical injury from use of a product and incurs expenses due to the resulting medical care and time off work. 

In Medical Marijuana, however, the Plaintiff/Respondents did not contend they suffered some adverse physician event from ingesting the defendants’ product, a CBD tincture.  Instead, the claim was that the plaintiff truck driver took the product because its label stated it was THC-free, when the product in fact had minute traces of THC.  The product caused no ill physical effects, but it did lead to a failed drug test and a lost of employment.  This line of questioning painted the Plaintiff/Respondent’s case as narrow and distinct from the usual product liability case, and sought to position the lost job, on these facts, a direct “injury to business” (the plaintiff’s business being employment as a truck driver) rather than a type of damage secondary to physical injuries caused by the product. 

A related thread dug into whether “medical expenses” are the same as, or different from, a loss of employment in this civil RICO context and on the particular facts of this particular case.  The Plaintiff/Respondent’s position was that medical expenses were not before the Court—Plaintiff had no adverse physical effect from ingesting the product, so he had no medical expenses—and the Supreme Court thus could duck that question if it wanted.  But if the Court were to address the issue, medical expenses certainly would be injury to property (in that money is property) and allowed under civil RICO, even if they flowed from a physical injury (as in a traditional personal injury, product liability case).

Justices Barrett and Kavanaugh had questions about the Defendants/Petitioners’ proposed interpretation of the statutory language, and authorities that support drawing a distinction between the terms “injury”  “harm” and “damages”.  Here, there were frequent references to “the Restatement” and “common law” as helpful guides.  To be honest, casual references to how things supposedly work in “product liability” set us a bit on edge, because we have seen non-experts get details about our area of the law wrong all too often.  We also worry about the “Always Liability Increases” tendencies that have crept into the ALI’s Restatement-drafting process, as well as the many nuances of product liability law that provide enough fodder to supply near-daily posts for this blog.   

Other questions from the Justices sought to address arguments by the Defendants/Petitioners (and amici) that upholding plaintiff’s interpretation would flood federal courts with state tort claims in civil RICO guise.  Some Justices sought to downplay those concerns, with questions highlighting guardrails imposed by other parts of the civil RICO statute, such as its causation requirement, or the need for a recognized RICO predicate act.  Justice Sonia Sotamayor, for example, stated during questioning that because product liability cases mostly involve “negligence or strict liability” they do not involve the “willfulness or intent” that civil RICO requires.  Having plenty of experience with the plaintiffs’ bar’s creativity in pleading and the sometimes fine line between things like “failure to warn” and “fraud”, we are not buying that assurance.     

We have to agree here with Defendants/Respondents and their amici.  If the Supreme Court converts what traditionally are called personal injury “economic damages” into business or property injuries recoverable under civil RICO, it does potentially turn many, if not most,  run-of-the-mill personal injury tort claim into triple-damages and attorneys’ fees civil RICO cases.  Assuming the plaintiff will be able to prove causation and shoehorn the case into a civil RICO predicate act (which they will, by calling an allegedly misleading drug warning “mail fraud” or some other such nonsense).  In the appellate world, litigants and amici often argue the sky will fall if the court adopts one view or another.  We don’t know if the sky will fall if the Court accepts plaintiff’s view, but we do think civil RICO filings will go through the roof. 

And now we wait for the opinion.  Stay tuned for Rico Madness, Part III when that opinion does come out.

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This is the second time in the last couple of weeks that we’ve written on a case brought under the False Claims Act (FCA).  That is no accident. We are about to start a FCA trial, and have been studying all things FCA.  Guess what we learned?  Most FCA claims are even more bogus than product liability claims.  The qui tam provision of the FCA, which permits private plaintiffs – sorry, relators – to steer FCA claims presents marvelous opportunities for mischief.  (And it’s probably barred by the “take care” clause of the U.S. Constitution, Article 2.  But we digress.)

In Lewis v. Abbvie f/k/a Allergen, 2024 U.S. Dist. LEXIS 192555 (N.D. Indiana Oct. 22, 2024), a former sales representative brought a FCA claim against his former employer, a pharmaceutical company. He alleged that after he “raised concerns with his supervisors regarding off-label prescription of a certain drug, he faced unlawful retaliation.”  The drug was approved for treatment of bipolar I depression, but was not approved for treatment of major depressive disorder or substance abuse.  The relator alleged that the defendant was “improperly positioning” the drug as a treatment for major depressive disorder and substance abuse by “pressuring and retaliating against sales representatives, illegal marketing tactics, illegal speaker campaigns, and inducements of medical professionals.” 

The government declined to intervene in this matter. 

The defendant filed a motion to dismiss. 

Then the relator amended his complaint to allege only a single count of retaliation under the FCA.  That slimmed down complaint removed any pretense that the relator was seeking compensation on behalf of the government. His case “was only brought on his own behalf.”

The defendant subsequently filed another motion to dismiss the amended complaint. The defendant’s argument was that the relator had failed “to demonstrate that he engaged in protected activity” or that the defendant “was aware that he was protesting fraud, and that he had failed to plead a plausible claim for retaliation.” 

The court granted the motion. 

The court held that the claim failed under the FCA because off-label promotion in and of itself, while it may run afoul of certain FDA rules in certain situations, does not support an FCA claim.  Rather there must be a causal nexus between the off-label speech and improper reimbursement requests made to the government.  The relator complained about supposed off-label promotional efforts, but never alleged that this conduct resulted in any claims submitted to any governmental program.  There was nothing in the complaint suggesting that a reasonable employee in the plaintiff’s (litigious) shoes “would believe that his employer was committing fraud against the government.”

The plaintiff was thus not engaged in any FCA protected activity by complaining about having to engage in off-label speech.  “Merely objecting to promotions or marketing that might lead someday to someone’s violation of the FCA through the submission of a false claim is insufficient.”

The plaintiff sought to save his case by attaching an exhibit and proposing yet another amended complaint.  Exhibits outside the pleadings are not ordinarily considered by courts when it comes to motions to dismiss, but here it didn’t matter.  The exhibit went to the relator’s objections to off-label marketing, but did not say anything as to whether a fraud against the government was actually consummated. In any event, the plaintiff had already amended once, and still could not manage to state a claim. At this point, the court had enough of the relator’s act. The relator had already been “rather replete” in alleging his griping to his employer about off label marketing, but “indefensibly anemic in alleging any fraud against the government.”  By now it was clear that “another attempt to amend would prove futile and wasteful.”  The Lewis court was not going to hand out another chance to amend.  Dismissal was with prejudice

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Ironically, today’s post is running a little late—because life’s not perfect and sometimes despite the best of intentions, you need a bit more time.  But, if you are going to ask for more time to meet a court ordered deadline to submit evidence that is critical to your case, you better ask in advance and you better be able to show that you really tried to make the deadline.  Otherwise, as the plaintiff in Eichen v. Ethicon Endo Surgery, Inc., learned, too little, too late can be too real.  2024 U.S. Dist. LEXIS 193526 (D.S.C. Oct. 24, 2024).

Plaintiff underwent removal of a portion of his colon which required the remaining portions to be reconnected. His surgeon used defendant’s surgical stapler to accomplish the reconnection.  Several days later, a revision surgery was required to repair a small hole at the point of the reconnection.  Plaintiff alleges that a defect in the stapler caused the hole and brought his lawsuit alleging strict liability design defect, manufacturing defect, failure to warn, and negligence.

The deadline for expert reports was first set for June 8, 2022, and was then extended by the court four times until March 15, 2024.  That deadline came and went with no motion to extend and no expert reports by plaintiff. So, defendant moved for summary judgment on several grounds, chief among them plaintiff’s lack of expert evidence.  A week later, plaintiff filed a motion to extend the expert report deadline.

Plaintiff argued that the court should extend the expert deadline because defendant’s discovery responses were deficient and a motion to compel would be forthcoming.  While plaintiff tried to invoke Federal Rule of Civil Procedure 37’s “substantially justified” or “harmless” standard, that applies to the admission of evidence that a party seeks to introduce despite failing to properly disclose.  But plaintiff did not even attempt to proffer an expert.  Instead, the rules that apply to determine whether to extend an expert deadline after the deadline has passed are Rule 6(b)(1)(B) and 16(b)(4).  The first gives the court discretion to extend the deadline on a showing of “good cause” where the failure to act was because of “excusable neglect.”  Rule 16 likewise requires a showing of good cause and notably it “does not focus on the prejudice to the non-movant or bad faith of the moving party, but rather on the moving party’s diligence.”  Id. at *14 (emphasis added).

Plaintiff could not demonstrate that he acted diligently.  Despite claiming he could not get an expert due to defendant’s deficient discovery responses, plaintiff admitted that product identification occurred four months before his expert reports were due and he took no action to either secure an expert or move to extend the deadline before it expired.  Plaintiff also failed to file a motion to compel, the deadline for which has also passed. Plaintiff also failed to initiate the court-required telephone conference to resolve discovery disputes.  Having taken no action at all, plaintiff’s motion to extend the scheduling order was denied.

Turning then to defendant’s motion for summary judgment, the court began with South Carolina’s general rule that “where the subject is beyond the common knowledge of the jury expert testimony is required.”  Id. at *19-20.  Because the question of “common knowledge” is fact specific, whether expert testimony is required is left to the discretion of the trial judge.  There was really no dispute that whether defendant’s surgical stapler contained a design defect is a complex issue requiring expert testimony. Id. at *20-22.  Nor could plaintiff establish causation without expert evidence. Whether defendant adequately warned about the risks associated with its surgical stapler:

turns on the knowledge, training, and experience of physicians, and it is precisely the type of information that is the subject of expert testimony.

Id. at *23. 

Plaintiff made two arguments in opposition to summary judgment.  First, he argued he did not need expert evidence to prove his manufacturing defect claim.  While some manufacturing claims may not require expert testimony, that is not the case here due to the “complexity and technical nature” of the surgical stapler, which plaintiff conceded by his belated request for more time to retain an expert.  Id. at *25. 

Second, plaintiff argued that because his surgeons testified that they could not state to a reasonable degree of medical certainty that the stapler caused the hole, there remains a question of material fact that prevents summary judgment.  The court found plaintiff “misused and misapplied” his surgeon’s testimony. Plaintiff also overlooked that both his surgeons testified that the complication plaintiff experienced is a known risk that can occur absent any product defect or wrongdoing.  Id. at *26.  To meet his burden of proof, plaintiff was required to produce affirmative evidence stated to a reasonable degree of medical certainty that a defect in the stapler caused his injury.  The fact that plaintiff’s surgeons could not offer such an opinion establishes just the opposite—that plaintiff failed to meet his burden of proof and defendant is entitled to summary judgment.  Id. at *26-27.       

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Unfortunately, the Third Circuit now seems to have a fetish with the presumption against preemption.  Not long after the Supreme Court abolished that presumption in express preemption cases in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), the Third Circuit refused to go along.  See Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771 n.9 (3d Cir. 2018) (finding Puerto Rico v. Franklin not controlling because it was not a product liability case).  Since then, as we discussed here, every other circuit court to address the issue has recognized the demise of the presumption against preemption in express preemption cases – several of them doing so in product liability litigation.  The Third Circuit stuck out like a sore thumb.

Then along came Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019).  In our initial “breaking news” post when Albrecht was first decided, we pointed out an interesting fact.  Among other things, Albrecht spent several pages restating and reworking the Court’s poorly reasoned Wyeth v. Levine, 555 U.S. 555 (2009), decision.  See Albrecht, 587 U.S. at 310-13 (“describing” Levine for four pages).  Levine, of course, had been the high water mark of the presumption against preemption, which it called a “cornerstone” of “pre-emption jurisprudence” generally.  555 U.S. at 565.  But nowhere in Albrecht’s discussion of Levine – indeed, nowhere in the Albrecht decision anywhere – did the Court even mention any presumption against preemption.  (If you don’t believe us, search Albrecht for “presum!”)  As we said then, “conspicuously absent from that description is any express reference to any ‘presumption’ (as opposed to the older ‘assumption’) against preemption.”  So on that issue, be believe that the Court in Albrecht actually pulled back from that presumption.

Continue Reading Challenging The Role of the Presumption Against Preemption in Fosamax
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This has been a big year for blood and tissue statute decisions. Given their subject matter, we’ve previously lamented that the decisions didn’t fall closer to Halloween. While not quite coinciding with our doorbells ringing and handing out candy to the little ones, today’s decision is close enough for a little seasonal digression.

Continue Reading Another Blood and Tissue Statute Win
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We have no personal knowledge of the litigation concerning GLP-1 receptor agonist medications and the Blog has not posted on it yet, but we do know something about litigation over widely used prescription medications.  Over the decades, there have been many drugs or classes of drugs that became “blockbusters” because they were widely prescribed to treatment of fairly common medical condition.  Often, even without reliable scientific research indicating a new or worse than previously suspected risk of a serious complication, litigation starts.  It is both a numbers game and a waiting game.  If there are enough cases and the cost of defense is high enough, then maybe the defendants will pay to end the litigation while the medications continue to be well-accepted.  If the litigation drags on long enough, then maybe there will actually be some science or liability evidence to support the plaintiffs’ claims after the fact.

Unless you have been living under the proverbial rock for several years, you have probably heard of the GLP-1 receptor agonist medications developed for diabetes and now widely prescribed for weight loss.  As veterans of prior litigation over multiple prescription diabetes and weight loss medications, we are aware of the significant individual and public health benefits from obese patients maintaining intentional weight loss and diabetics lowering their glycosylated hemoglobin levels.  When we look at the primary alleged injury in the MDL created for product liability claims over the GLP-1 receptor agonist medications, gastroparesis, we are underwhelmed.  (Apparently, the JPML may add venous thromboembolism claims to the mix.)  A perusal of the first few sentences from the pertinent Wikipedia entry—surely, the most superficial of inquiries—tells us that gastroparesis results “in food and liquid remaining in the stomach for a prolonged period of time,” which can cause symptoms such as “nausea, vomiting, abdominal pain, feeling full soon after beginning to eat (early satiety), abdominal bloating, and heartburn,” and that it is often idiopathic or due to damage to the vagus nerve from uncontrolled diabetes.  Early satiety is the point of the use of a GLP-1 for weight loss and, as expected, delayed gastric emptying and all of those resultant symptoms are labeled.  So, at first and second blush, the litigation does seem to fit the pattern described above.

The defendants were wise to propose and the MDL court was wise to accept bifurcated discovery so that threshold (or “cross cutting” as used in the decision we will be getting to) issues could be addressed first.  The three issues to be decided first, after appropriately tailored discovery, are “(1) gastroparesis diagnostic testing, (2) preemption and adequacy of warnings, and (3) general causation.”  In re Glucagon-Like Peptide-1 Receptor Agonists Prods. Liab. Litig., MDL No. 3094, 2024 U.S. Dist. LEXIS 188802, *3 (E.D. Pa. Oct. 17, 2024) (“GLP-1”).  Plaintiffs being plaintiffs, they urged that they should be allowed to pursue unfettered discovery into the marketing of the five different prescription medications currently at issue in the MDL before the court decides those threshold issues.  Even without going into the arguments offered by plaintiffs for why they should get such broad early discovery, we can offer that there are three real reasons:  1) marketing discovery will be costly and burdensome for defendants (see above); 2) marketing discovery will likely take time and bog down with motions practice, meaning it takes even longer (see above); and 3) marketing discovery may turn up something sufficiently salacious, but not substantive, to deter the court from issuing rulings on the threshold issues that are favorable to the defendants.  The decision in GLP-1 was actually on a motion to reconsider from plaintiffs after they lost the issue originally.  They started with the dubious position that the standard for deciding this motion to reconsider should not be derived from Fed. R. Civ. P. 59(e) as it usually is, because somehow the original decision was not on a full record.  They lost this argument and the motion, which was decided on the applicable “clear error of law” standard.

Given that plaintiffs had recycled their arguments that were rejected originally, the focus of the GLP-1 decision was to clarify the court’s prior analysis on why alleged overpromotion of the drugs is irrelevant to whether the warnings in their respective labels were adequate and whether any claim of inadequacy as to the label would be preempted because the allegedly required changes were not possible.  Id. at *17-18.  Plaintiffs argued, largely based on an early decision from the Avandia MDL, that marketing conduct must be examined to determine the adequacy of warnings.  (We note that later decisions from that MDL, including those affirmed by the Third Circuit, granted summary judgment on a number of warnings claims.)  From our perspective, even though it came to the right conclusion, the analysis in GLP-1 was a bit too generous to plaintiffs’ position in two respects. 

First, the GLP-1 court played along with some of the plaintiffs’ three-card monte with the words warnings, warn, label, and labeling.  The warnings in a label as to particular risks can be held to be adequate as a matter of law.  Claims based on the assertion that the label had to include specific additional information at a specific time to adequately warn of the true risks can be held to be preempted.  Either of those holdings usually will mean that the plaintiff loses her claim for failure to warn, but that is not always the case.  For instance, the warnings in the label could be adequate as to one but not both of the injuries the plaintiff alleges.  Or the asserted warnings claim could be preempted to the extent it is based on an alleged inadequacy during part of the time the plaintiff was prescribed the drug.  Or, in one of the few states that has law providing that “overpromotion” to the particular prescribing physician to undo the adequacy of the warning in the label, the plaintiff might have a chance to prove such an exception applies.  The court can decide the adequacy of the relevant warnings in the label and how impossibility preemption applies without looking at marketing broadly or individually.  Communications to physicians outside of the label (i.e., the package insert),

are not needed for the Court to determine whether a drug’s approved label already contains the warnings that Plaintiffs seek to add and if not, whether the FDA would have rejected additional warnings to the approved label, such that Plaintiffs’ state law failure to warn claims are preempted.

Id. at *28-29.

Second, in two footnotes, the GLP-1 court recapped that Avandia could identify Pennsylvania as the only state with an overpromotion exception and that its own research turned up a handful of other states that might also have some form of exception.  Id. at nn.7-8.  Generally, these cases involve, somewhat like Perez with direct-to-consumer advertising in New Jersey, the idea that the focus in an individual case should be on the warnings provided to the plaintiff instead of the warnings provided to the learned intermediary.  We will not belabor why those cases tend to be wrong, but we can say the substantive law of the forty-five or more states without such an exception would definitely not make marketing conduct relevant to determining label adequacy or the conflict with federal law.  Expanding the scope of discovery based on maybe 10% of the states instead of the other 90% or so would be strange. However, the court correctly concluded that the analysis of overpromotion where there is a recognized exception is a highly case-specific inquiry.  Id. at n.8.  The implication of that conclusion is that early generic discovery need not be expanded because of possible additional discovery in individual cases down the road.  Although the court did not have to go beyond relevance, a proportionality analysis under Fed. R. Civ. P. 26(b)(1) would have further supported the limit the court imposed.

At the end of the day, by keeping discovery focused on what the defendants knew, what the labels said, what FDA was told, and what FDA would have done with theoretical labeling changes, the court increased the chance of clean decisions on the adequacy of the warnings in the labels and the preemption of certain label-based warnings claims.  Along the same vein, we made sure to avoid any quips or wordplay about weight or weight loss so we could present what was really a fairly straightforward issue.

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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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