In the present day’s case — In re Tepezza Mkt’g, Gross sales Pracs., & Prod. Liab. Litig., MDL No. 3079, 2025 WL 81338 (N.D. In poor health. Nov. Jan. 10, 2025) – doesn’t actually break new floor on the substantive regulation, in truth it’s a cut up resolution. Nevertheless it comes from an uncommon procedural posture value declaring.
The Tepezza MDL was created in June 2023 and shortly thereafter the court docket dominated on a pending movement to dismiss in a single case. The court docket denied the movement as to plaintiff’s pre-market design defect claims. We weren’t notably keen on the ruling and stated so right here. It seems that since that point, the court docket determined to create a bunch of “bellwether discovery” instances. The concept is that motions to dismiss get teed up and dominated on within the 12 “bellwether discovery” instances to determine the scope of discovery. We will’t assist however be intrigued with any course of which has as a part setting boundaries on discovery. Realistically, particularized rulings on plaintiffs’ claims may result in much less discovery. As an illustration, sure time durations might be deemed out of bounds. Or, if design defect claims are dismissed, which may restrict the quantity of analysis and improvement discovery that’s warranted. Moreover, tethering the invention to the claims of 12 precise plaintiffs, whatever the rulings on the motions, may be doubtlessly useful to defendants. Typically, discovery in opposition to the producer in an MDL tosses open the doorways to the corporate at giant as a result of plaintiffs declare they’re taking discovery for all plaintiffs, for all functions, for all claims, for all instances. Placing discovery in context, together with the context of 12 particular person plaintiffs, virtually all the time inures to the advantage of the protection. For our readers who spend a major time slogging it out with plaintiffs on discovery disputes, we’ll preserve our eyes on whether or not this discovery bellwether generates any helpful precedent or ideas going ahead.
Now to show to the substance. Plaintiffs within the Tepezza MDL allege “listening to loss and/or tinnitus” from using an FDA-approved prescription biologic for thyroid eye illness. Defendants challenged the bellwether plaintiffs’ failure to warn, design defect, and fraudulent misrepresentation. They gained one, misplaced one, and cut up one.
On failure to warn, defendant argued that the claims had been preempted as a result of plaintiffs didn’t adequately plead that defendant may have used the CBE course of to alter its label earlier than September 2022—after plaintiffs had stopped their therapy. First, we should always level out that whereas Tepezza is a biologic, the CBE regulation is substantively equivalent to that for pharmaceuticals. So, to keep away from preemption, a plaintiff “should plead that the producer had newly acquired info that confirmed a causal affiliation between the drug and an impact that warranted a brand new or stronger warning, precaution, or antagonistic response within the label.” In re Tepezza, at *4. In that state of affairs, the producer doesn’t want FDA approval to alter its label; due to this fact, no preemption. Right here, plaintiffs cited to a scientific examine that got here out in September 2020 that confirmed a ample enhance within the incidence charge to arguably fulfill the CBE necessities. Id. at *5. Defendant argued that the examine couldn’t kind the premise for a CBE label change as a result of it was not a “scientific trial,” however the court docket discovered “criticism of the standard of [the study] . goes to the sufficiency of the proof proving the allegations, not the sufficiency of the allegations. Since the entire bellwether plaintiffs used Tepezza after September 2020, their failure to warn claims weren’t preempted on the pleadings stage.
On design defect, plaintiffs failed to fulfill the TwIqbal pleading normal. In actual fact, plaintiff solely made boilerplate allegations providing no info and giving the court docket no foundation from which to deduce what side of the product makes it faulty. Plaintiffs tried to argue that below not less than Florida and New York regulation, they didn’t must allege a design defect earlier than discovery as a result of they don’t have the technical info required to take action. Nevertheless, plaintiffs relied on instances during which the complaints contained many extra factual particulars than they allege right here. Plaintiffs don’t need to show a selected defect of their grievance, however they’ve “to do greater than assert the conclusion that Tepezza is flawed.” Id. at *7. Plaintiffs’ allegations about dosage weren’t supported by the proof they pointed to within the grievance. Furthermore, merely alleging that dose is just too excessive doesn’t fulfill the necessity to allege another design. Id. at *9. With design defect dismissed, plaintiffs requested for permission to amend their complaints—lengthy after the MDL deadline to take action. They claimed that they’d new proof that defendant was conducting a scientific trial on a brand new supply technique. Not solely was the examine introduced months earlier than the pleadings deadline, however it was additionally not scheduled to be accomplished till 2026 and had no security or efficacy outcomes as of but. The ”mere initiation of a examine” doesn’t “plausibly recommend” a defect within the present supply technique or point out that the tactic being studied will transform safer or extra efficacious. Plaintiff didn’t supply good grounds for his or her movement to amend, and it was denied.
That left solely plaintiffs’ fraudulent misrepresentation declare which was primarily the identical as their failure to warn declare. Plaintiffs’ fraud declare was based mostly on two allegations—that defendant overstated the efficacy of the biologic and defendant misstated the incidence charge. Making use of Rule 9’s heightened pleading requirement for fraud, the court docket discovered each allegations had been missing. The primary was merely not supported by any factual allegations (“plaintiffs’ allegations relating to efficacy are extremely generalized”). Id. at *10. As to the second, plaintiffs had conflicting allegations, together with statements that the incidence charge on the label was correct. “So, Plaintiffs’ assertion of falsity shouldn’t be effectively pled.” Id. at *11. Whereas the fraud itself was not sufficiently pleaded, the court docket discovered plaintiffs’ fraud damages needn’t be pleaded with particularity. And defendants raised another difficulty—that as a result of the fraud declare is predicated on the FDA-approved label, it’s really a preempted fraud-on-the-FDA declare. Right here the court docket concluded it had inadequate info on which to base a choice. As a result of the fraud declare is substantively the identical because the failure to warn declare, a ruling on Buckman preemption wouldn’t change the scope of discovery, and due to this fact the court docket deferred the problem. So, on fraudulent misrepresentation the ultimate ruling is defendant’s movement to dismiss is granted partly (fraud allegations), denied partly (damages); and continued partly. Besides as to the Pennsylvania plaintiff as a result of Pennsylvania doesn’t acknowledge fraud claims based mostly on a failure to warn principle. Her declare was dismissed with prejudice.
Like we stated, a 50/50 cut up resolution on the claims—however a attainable case to observe for discovery.