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It’s the most wonderful time of year, or at least Sirius channel 79 keeps telling us that.  Too much food, too much drink, too much family, and not quite enough presents.  Or, at least, not enough of the right presents.  Or, maybe, lots of those veritable mixed bags.  You know – a six pack of Samuel Smith’s oatmeal stout (for the moment, we will forget about that ‘too much drink’ remark above), and a six pack of white tube socks.  You smile ruefully at the socks. Then you reach for the bottle opener.

Today’s case, Weider v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025), is a mixed bag.  To be sure, it is mostly good. It contains a splendid class III, premarket approval (PMA) preemption decision by a magistrate judge.  At the same time, it is slightly spoiled by a case-specific negligent undertaking claim about post-implant testing surviving non-preemption challenges.  We’ve been talking in terms of holiday gifts, but tomorrow’s holiday is Thanksgiving, so let’s consider Weider in a different way. The application of preemption is like the delightful, satisfying turkey, spuds, stuffing, and cranberries.  But at the end, squatting in squalid loneliness on the plate is the lump of turnips.  Do we really have to eat that? We look over at Aunt Marie, who made the turnips, just like she has for 60 years.  Yes, we have to.

Let’s set the table. The product was a cochlear implant.  The plaintiffs were suing on behalf of their child, who had received the cochlear implant. They alleged that an inadequate seal permitted moisture ingress, which caused a short circuit in the medical device, which caused a malfunction, which caused permanent problems in terms of hearing and the patient’s ability to speak and learn. The plaintiffs’ first amended complaint (FAC) contained claims of manufacturing defect, design defect, breach of an implied warranty of merchantability, violations of New York General Business Law sections 349-50, negligent failure to warn, negligence, and loss of services. The defendant moved to dismiss the FAC on the grounds that it was preempted by federal law and/or otherwise failed to state a claim for relief. That motion succeeded — mostly. 

First, the plaintiffs failed to allege any manufacturing defect with sufficient specificity.  New York law, like most places, provides that a strict liability manufacturing defect claim be supported by a showing that the product did not perform as intended because of “some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction.” To get past the Riegel/Medical Device Amendments section 360k(g) express preemption of any requirement that is “different from, or in addition to, any requirement applicable to a medical device under the Food, Drug, and Cosmetic Act (FDCA) the plaintiff must hang a manufacturing defect on a violation of a state rule that is parallel to the federal rule.  The plaintiff in Weider failed that test. The FAC included a conclusory laundry list of purported Current Good Manufacturing Practice (CGMP) violations, including an alleged inconsistency, but that was not enough. It alleged that the silicone seal was “applied manually by manufacturing workers,” but that was not enough. The FAC also cited to a voluntary recall, but that bare fact was not enough. It certainly did not establish an unpreempted design defect.    

Second, the design defect claims facially challenged what the Food and Drug Administration (FDA) approved and were, therefore, preempted. Under New York law, “[t]o establish a prima facie case for design defect, the plaintiff must show that the defendant breached its duty to market safe products when it marketed a product designed so that it was not reasonably safe and that the defective design was a substantial factor in causing plaintiff[‘]s injury.”  The design defects alleged in the FAC were either too vague or actually sounded like manufacturing defects, but either way, the FAC’s allegations “directly challenge[] the FDA’s judgment in approving the allegedly defective” design “and thereby seek to “impose different or additional standards” on the product line “in violation of the MDA.”

Ditto for implied warranty.  The parties agreed that the warranty claim “rises or falls with the[] manufacturing defect and design defect claims.” So they fell.

Similarly, the negligent warning, consumer fraud, and fraud claims challenged FDA-approved warnings and were, again, preempted. The guts of these claims was that the defendant allegedly did not disclose the true failure rate of the cochlear implants. According to the plaintiffs, the disclosure of the true failure rates should have been included in various “consumer-oriented” statements. But the plaintiffs offered no allegations that the defendant made statements contrary to what the FDA approved. Moreover, even if New York law can be construed to mandate non-physician warnings, the FDCA does not. Consequently, the plaintiffs’ theory would impose a state requirement that is “different from, or in addition to” the FDA’s requirements.  Hello, FDCA preemption, goodbye claims.  

The negligent warning claim based on failure to report allegations was also preempted. Under New York law, device warnings go to learned intermediaries, not regulatory agencies.  The FDA is not a learned intermediary. After all, the FDA does not treat patients. Further, there is no basis to believe that a warning to the FDA “necessarily or even likely results in a warning to treatment providers.” A failure to warn claim under New York law would be “different from, or in addition to” a manufacturer’s duty to supply adverse event reports to the FDA. In any event, factually, the plaintiffs’ warning claims were conclusory and contradictory.  

So far, so good. Now we get to the turnips or, if you prefer, the not so good present. (Think of the Jelly of the Month club certificate that Clark Griswold gets in National Lampoon’s Christmas Vacation). The negligent undertaking claim rested on Restatement of Torts (Second) section 323, which provides that one “who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of the other’s person or things, is subject to liability to the other for physical harm resulting from his failure to exercise reasonable care to perform his undertaking if (a) his failure to exercise such care increases the risk of such harm, or (b)the harm is suffered because of the other’s reliance upon the undertaking.” Call it the no-good-deed-goes-unpunished proposition. The plaintiffs contended that a sales representative of the manufacturer conducted “integrity testing” of the subject device and incorrectly concluded that it was working properly. The defendant did not contend that a negligent undertaking claim based on a representative’s testing of the device while implanted was preempted. Rather, the debate was whether there was any duty in this case. The defendant pointed to New York cases holding that a manufacturer is not generally responsible for how a physician uses a device and renders medical care, and that New York law does not recognize a duty to test.  But the Weider court concluded that the plaintiffs’ factual allegations about known problems with the testing were sufficient to state a negligent undertaking under New York law.  Thus, the negligent undertaking claims, as well as the claim for loss of services, were the only causes of action that escaped preemption in Weider.

In the spirit of the season, we will not grouse unduly about the survival of what we see as frail causes of action,  Instead, we’ll give thanks for the excellent preemption rulings. And you’ll be thankful that we are abstaining from any turkey or other fowl puns.

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Today’s guest post is from Dechert’s Chris McKeon who updates us on a rare application of the political question doctrine. As always, our guest posters deserve 100% of the praise (and any of blame) for their posts. Not that we expect the latter.

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In our earlier post, we explored whether the political question doctrine can supply a jurisdictional off-ramp for design-defect claims against FDA-approved prescription drugs.  The district court in Caston embraced that idea in a seemingly novel way, holding that “pharmaceutical design defect claims challenging active ingredients necessarily implicate a nonjusticiable political question” because re-evaluating—years after the fact—FDA’s safety and efficacy determinations is “heavily scientific, and indeed economic and political, but not judicial.”  Caston I, 729 F. Supp. 3d 930, 946 (N.D. Cal. 2024). 

The Ninth Circuit has now weighed in.  In an unpublished and nonprecedential decision, the panel affirmed in part, vacated in part, and remanded—rejecting the district court’s political-question dismissal, affirming dismissal for lack of personal jurisdiction against one set of Defendants, and giving Plaintiffs a chance to re-plead Article III standing for their medical-monitoring theory against the remaining Defendants.  Caston II, No. 24-2920, 2025 WL 3205856 (9th Cir. Nov. 17, 2025).  The opinion returns this case to the well-trodden battlegrounds of products liability: jurisdiction, preemption, and standing.

The panel began by characterizing the political question doctrine as a “narrow exception” that applies only when adjudication will “certainly and inextricably” require courts to decide issues constitutionally committed to another branch.  Caston II, 2025 WL 3205856, at *1.  Citing Zivotofsky v. Clinton and Cooper v. Tokyo Electric Power, the panel held: “The district court erred in dismissing [Plaintiffs’] products-liability claims under the political question doctrine based on the FDA’s approval of mefloquine.”  Id.

Next, the panel leaned on a numbers-based approach, asserting that “[f]ederal and state courts have consistently adjudicated design-defect and failure-to-warn claims regarding FDA-approved pharmaceuticals without treating them as nonjusticiable.”  Id.  The panel pointed to Bartlett, Wyeth v. Levine, and Mensing—all cases that addressed preemption, not justiciability.  Id.  The takeaway is clear: in the panel’s view, the mere fact that a product is subject to FDA regulation does not convert ordinary tort claims into political questions, though the panel’s citations tally decisions rather than engage in the justiciability analysis.

What about the military overlay?  The panel was cautious: “It would be premature to invoke the political question doctrine based on the military’s approval of mefloquine.  [Plaintiffs] argue that their claims rest on [Defendants’] own conduct without requiring judicial review of military judgments.  At this stage, it is speculative to consider how the military dimension of the political question doctrine might come into play. The district court may revisit the issue at a later stage of this litigation.”  Id.  That leaves room for a properly developed government-contractor defense or a Baker v. Carr analysis if the record later shows that adjudication would intrude on the military’s decisions.  But the panel refused to assume that intrusion now.

At the very least, the panel affirmed dismissal of claims against the Roche Defendants for lack of personal jurisdiction.  Caston II, 2025 WL 3205856, at *2.  On specific jurisdiction, the panel emphasized the locus of ingestion and injury: “[Plaintiffs’] claims arise from their ingestion of mefloquine overseas and at East Coast military bases—not in California.”  Id.  Thus, Plaintiffs could not show that their injuries “arise out of or relate to” California-directed conduct by Roche.  In addition, allegations of national distribution and a California presence by a military agency were insufficient: “mere placement of a product into the stream of commerce, without more, is not purposeful direction toward the forum.”  Id. (citation omitted).

The panel held that Plaintiffs’ medical-monitoring allegations did not establish Article III standing but remanded to permit amendment “to clarify how the requested monitoring program would likely redress their alleged injuries.”  Id. (citation omitted).  Finally, the Greentech Defendants cannot obtain dismissal on preemption grounds—at least not under Mensing—as Greentech is not a generic manufacturer.  Id. at *3.

Bottom line, FDA regulation does not make routine pharma torts nonjusticiable, and without a record showing adjudication would certainly and inextricably intrude on another branch—military issues included—the political question doctrine inquiry is premature; the district court’s ruling will not stand, and Caston returns to familiar terrain where the ultimate outcome will turn on facts, other legal bases, and careful framing.

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Another two years have elapsed (since October, 2023) since we last updated our cheat sheet devoted to ediscovery for defendants.  That’s because finding good, pro-defense ediscovery decisions is a hard and time-consuming task – and getting harder.  Unlike most of our other cheat sheets and scorecards, cases involving defense discovery of plaintiffs’ social media can be found in a wide variety of non-drug/device contexts – other personal injury, employment, civil rights, anything where a plaintiff’s personal conduct could be relevant.  That means our various automatic Westlaw/Lexis searches designed to find drug- and medical device-related decisions aren’t nearly enough.  Ediscovery research is problematic because any search broad enough to be comprehensive also produces a lot of cases having nothing to do with the topic.  And as social media and text messaging becomes ever more ubiquitous, more and more cases mention it.  This time we had reviewed a thousand cases, and our cutoff was to some extent arbitrary.

But we bit that bullet, and this post contains our latest additions (also added to the cheat sheet itself) of ediscovery decisions that are both:  (1) on point, and (2) favorable to our side of the “v.”  We’re picky.  Each of the new cases below either allows essentially all the access to some plaintiff’s social media activity that a defendant sought, or imposes significant sanctions (such as spoliation) on a plaintiff who improperly failed to comply with social media discovery.  We have now compiled more than 250 decisions from some 40 American jurisdictions (and three Canadian provinces) – all supporting defendants’ rights to take discovery of plaintiffs’ social media.

We add our usual caution about defense-side social media ediscovery.  We continue to believe that it’s not a good idea for a defendant to follow the other side’s usual playbook – to make a broad request for everything social-media-related at the beginning of the case – instead send a preservation letter, or even better get a court preservation order.  Courts don’t tend to give defendants the same latitude as plaintiffs to make wide-ranging discovery demands, and the likely result is “no, that’s a fishing expedition.”  A defendant is much more likely to succeed with a blanket social media discovery demand once it has caught the plaintiff in some kind of chicanery – such as particular public social media content contradicting either plaintiff’s own discovery responses or some open-court representation − or when a plaintiff is found to be deleting or otherwise hiding social media activity.  Take the initiative and investigate.  Engage in some self-help (but don’t mislead anyone).  Once a plaintiff is caught, broader social media discovery follows more easily.

Thus, without hard evidence of the other side’s concealment, starting small, with less intrusive social media discovery is more likely to succeed.  If there’s potentially a lot out there, engage an ediscovery specialist and perhaps propose sampling – 5% or 10% of the entire universe of posts – as something less intrusive, but statistically likely to find uncover contradictory statements.  An active social media user (the kind most likely to generate useful information) usually has thousands of potentially discoverable items.

With these caveats, here are the latest favorable decisions allowing defendants to conduct ediscovery of plaintiff social media:

  • Kutz v. NGI Capital, Inc., 2023 WL 3790766 (D. Minn. June 2, 2023).  Plaintiff is ordered to produce social media, text messages, emails, and accompanying photographs within a set time period around the allegedly emotional events involved with the litigation.
  • Acon v. Long Island Gay & Lesbian Youth, Inc., 2023 WL 12073648 (Mag. E.D.N.Y. July 7, 2023).  Plaintiff claiming emotional distress ordered to produce social media content, including photos, videos, captions, comments, and messages, that:  (1) relates to the allegations in the complaint; (2) contains specific references to or depicts the emotional distress plaintiff claims or resulting treatment or (3) refers to or depicts an alternative potential stressor.  Plaintiff must also preserve all social media activity for the duration of the litigation and inform the defendant of all the social media platforms that she has used and all usernames.
  • Taneja v. Freitas, 2023 WL 4866452 (W.D. Wash. July 31, 2023).  Plaintiffs clearly incomplete production of their text messages warranted monetary sanctions.  Plaintiffs never explained how responsive messages were omitted.
  • Gibbs v. Abt Electronics, Inc., 2023 WL 6809610 (N.D. Ill. Oct. 16, 2023).  To investigate plaintiff’s mitigation of damages, defendant is entitled to full and complete discovery regarding plaintiff’s post-termination online job search efforts including ESI from the websites he utilized.
  • Johnson v. Estate of Hazen, 2023 WL 7186883 (Mag. D. Kan. Nov. 1, 2023).  Plaintiff is compelled to produce all his social media posts, including non-public posts to “friends,” since the date of the accident in question that relate to his physical abilities, activities, injuries, or lack thereof.
  • Ball v. Hudson Insurance Co., 2023 WL 8190152 (Mag. M.D. La. Nov. 27, 2023).  Plaintiff ordered to produce all social media posts from the date of the alleged accident to the present, relating to the accident; her physical injuries, medical treatment, and claimed disabilities or limitations; her job or employment status and ability to work; and reflecting capabilities inconsistent with her alleged injuries.
  • Wingo v. 3M Co., 2023 WL 8714499 (Mag. D. Minn. Dec. 18, 2023).  Plaintiffs’ failure to disclose social media and text messages was comprehensive, misrepresented, and allowed them to give contradictory deposition testimony.  Plaintiffs must explain why defendant should not recover its additional costs incurred in pursuing social media discovery.  Further failure to comply will result in plaintiffs’ claims being dismissed with prejudice.
  • Militante v. Banner Health, 2023 WL 12073895 (Mag. D. Ariz. Dec. 20, 2023).  Social media discovery is relevant to causation and extent of plaintiff’s alleged emotional injuries.  Discovery responses must include non-public social media.  That defendant had access to public social media does not excuse plaintiff from producing it.
  • S.C. v. Wyndham Hotels & Resorts, Inc., 2024 WL 21548 (N.D. Ohio Jan. 2, 2024).  Plaintiff ordered to produce a full download of her social media.  A full download is not burdensome, since social media will contain little if any privileged information, particularly since it predates the suit.  A confidentiality order is in place.  The social media activity is closely related to core issues, how the alleged illegal conduct began, and damages.
  • Cronick v. Pryor, 2024 WL 50194 (D. Colo. Jan. 4, 2024).  Sanctions imposed.  Plaintiff’s inexplicable failure to produce relevant social media content amounts to a willful discovery violation.  Her nonsensical reasons strongly suggest purposeful obstruction.  Plaintiff must pay defendant’s costs and an adverse inference of some sort will be given.
  • Johnson v. Knox County Schools, 2024 WL 2029196 (Mag. E.D. Tenn. Jan. 29, 2024).  Forensic examination of plaintiff’s cellphone ordered in light of unexplained disappearance of relevant text messages.  Production of missing messages from other persons has been incomplete.  From the results of that examination, plaintiff shall produce all relevant text messages.
  • Alsaadi v. Saulsbury Industries, Inc., 2024 WL 460050 (Mag. D.N.M. Feb. 6, 2024).  Plaintiff’s supplemental productions belie her statement that she has no more responsive text messages.  Parties are required to make a diligent search for responsive documents upon receipt of discovery requests.  Plaintiff apparently has not.  Plaintiff must produce the additional messages or certify exactly what  searches she has undertaken to find responsive information.
  • Doe 1 v. National Collegiate Athletic Assn., 2024 WL 643038 (S.D. Ind. Feb. 15, 2024).  Plaintiffs may not hold plainly discoverable ESI hostage to the defendant agreeing to limits that they demanded on other material.  Plaintiffs shall produce an export of all information associated with each of their social media accounts, including any private messages.  Automatic production is not burdensome.  Privacy concerns can be addressed through protective orders and sealing.
  • Lin v. Solta Medical, Inc., 2024 WL 858750 (N.D. Cal. Feb. 15, 2024).  Since plaintiff claims the occupation of “social media influencer,” all of her social media posts, public and private are relevant to her claimed damages and must be produced, including accounts plaintiff claims are jointly owned and operated.  Plaintiff must also identify any omitted social media accounts.  Plaintiff must produce social media for the entire period for which she seeks damages.
  • Doe v. Carnival Corp., 2024 WL 4003709 (S.D. Fla. Feb. 22, 2024).  Plaintiff compelled to produce entire group chat following three insufficient partial productions.  Discovery reopened to accommodate the ordered full production.
  • Treminio v. Crowley Maritime Corp., 2024 WL 1075433 (M.D. Fla. March 12, 2024).  As a sanction for plaintiff’s unexplained deletion of relevant emails from her cellphone, defendant is entitled to a forensic examination of all of plaintiff’s devices paid for by plaintiff.  Additional discovery is also ordered.
  • Gorman v. Douglas County Sheriffs’ Office, 2024 WL 1211798 (D. Or. March 21, 2024).  Plaintiff delayed producing texts and social media from his cellphone and then spoliated his entire cloud backup.  Digital extraction was not unreasonable, given the suspiciously timed damage to the cellphone.  The loss of text messages and other ESI threatened to distort the resolution of the case.  Since summary judgment has been entered on the merits, an appropriate sanction is payment of the costs and attorney fees incurred in obtaining the digital extraction.
  • Windish v. 3M Co., 2024 WL 1604012 (E.D. Pa. April 12, 2024), aff’d, 2025 WL 572386 (3d Cir. Feb. 21, 2025).  Plaintiff repeatedly and deliberately violated orders to produce social media discovery.  She lied about her extent of use and about discussions with others employed by defendant.  Relevant social media discovery was plainly covered by the court’s order and within plaintiff’s control.  Even now, significant discovery remains undone.  Plaintiff’s action is dismissed with prejudice.
  • Ramsey v. Snorkel International, Inc., 2024 WL 1834365 (Mag. D. Kan. April 26, 2024).  In light of prior inadequate productions, plaintiff is ordered to conduct a diligent search of all social media and email accounts, supervised by his counsel.  Counsel is ordered to serve a signed certification as to his supervision.  If dissatisfied, defendant can pay for a forensic search of these accounts, with which plaintiff must cooperate, with sanctions possible.
  • Vorhees v. Esurance Insurance Services, Inc., 2024 WL 1972899 (W.D. Wash. May 3, 2024).  Motion to compel granted.  Defendant’s request for plaintiff’s social media posts from the date of the accident through the present is relevant and proportional.  Social media information revealing that the plaintiff is lying or exaggerating the claimed injuries should not be protected from disclosure.
  • Schall v. Nodak Insurance Co., 2024 WL 2355714 (Mag. D. Neb. May 23, 2024), objections overruled, 2025 WL 50144 (D. Neb. Jan. 8, 2025).  Plaintiff compelled to produce social media posts, pictures, videos as relevant to his emotional distress claim.
  • Saunders v. Signature Flight Support, LLC, 2024 WL 5671955 (Mag. M.D. Fla. June 4, 2024), adopted, 2024 WL 5671946 (M.D. Fla. Sept. 12, 2024).  Dismissal with prejudice ordered for extended failure to produce cellphone text messages, including making numerous false statements in court filings and at hearings and producing data in a manifestly inadequate form of a video of a scrolled computer screen.
  • Vancza v. Marist College, 2024 WL 3026683 (Mag. N.D.N.Y. June 17, 2024).  Plaintiff ordered to pay for a complete forensic examination of her cellphone due to spoliation of evidence and non-disclosure of her replacing the phone and failure to transfer relevant messages.  Plaintiff was consistently non-cooperative with ESI discovery.
  • M.A. v. Wyndham Hotels & Resorts, Inc., 2024 WL 3029215 (S.D. Ohio June 17, 2024).  Plaintiff’s deposition was reopened as a sanction for extended refusal to produce critically relevant social media activity.  For years, declined to identify any friends or family with whom she interacted during the relevant period.
  • Kellar v. Union Pacific Railroad Co., 2024 WL 3818535 (Mag. E.D. La. July 26, 2024), adopted, 2024 WL 4649244 (E.D. La. Oct. 17, 2024).  Plaintiff’s failure to provide the ordered complete extraction of cellphone data warranted adverse inference and monetary sanctions.  Plaintiff’s counsel failed to ensure preservation.  Instead it turned out that the phone had been factory reset, causing all the relevant data to be irrevocably lost.  Evidence indicated intentional spoliation.
  • Hernandez v. Thomas, 2024 WL 3511640 (Mag. S.D. Ga. July 23, 2024).  Defendant is entitled to unfettered forensic access to plaintiff’s cellphone and to any separate cloud backup.  Newly produced extraction data included numerous text messages, photos, and videos that were not included in the initial extraction.  Plaintiff’s explanations for late and incomplete production of social media and text messages has been inconsistent and possibly perjured.  There is also evidence of spoliation.
  • Michaels v. Embry-Riddle Aeronautical University Inc., 2024 WL 5484096 (M.D. Fla. Aug. 21, 2024).  Motion to compel granted for plaintiff’s social media and text messages.  Plaintiff is required to engage an ediscovery specialist to ensure she discharges her discovery obligations.
  • Pashaie v. H77LA, LLC, 2024 WL 4800698 (Mag. C.D. Cal. Sept. 9, 2024).  Motion to compel granted ordering plaintiff to obtain and pay for imaging of his cellphone so that all texts can be searched.  Counsel fees are also awarded.
  • James v. Professional Contract Services, Inc., 2024 WL 4858593 (Mag. S.D. Ga. Nov. 21, 2024).  Plaintiff must produce all phone records and text messages relevant to his claims in this lawsuit within 30 days.
  • Bailey v. Recreational Equipment, Inc., 2024 WL 4957279 (Mag. E.D.N.Y. Nov. 21, 2024).  Discovery of a party’s social media information provides relevant information about that person’s emotional or mental state, physical condition, level of activity, impact on employment, and the injuries claimed.  Defendant’s tailored discovery is appropriate and not invasive.  Plaintiff must produce responsive social media or a sworn affidavit that there are none and must also swear to the status of his former accounts and what efforts he made to comply with discovery of them.
  • Long v. Pratt (Target Container), Inc., 2025 WL 305881 (Mag. M.D. Fla. Jan. 27, 2025).  Plaintiff ordered to produce all text messages between her and two witnesses.  Her incomplete and disjointed voluntary production was insufficient.
  • Jones v. AssuredPartners NL, LLC, 2025 WL 373449 (W.D. Ky. Feb. 3, 2025).  Defendant is entitled to all electronic communications between the specified individual plaintiffs.  Forensic evidence is suggestive of spoliation.  The discovery is proportionate to the case.  Much of discovery is a fishing expedition, but with the courts determining the pond, the lures, and how long parties may keep their lines in the water.
  • Witham v. Hershey Co., 2025 WL 444399 (Mag. D. Minn. Feb. 10, 2025), adopted, 2025 WL 841024 (D. Minn. March 18, 2025).  Plaintiff’s production of social media was non-compliant and his use of search terms that created himself is hopelessly inadequate.  His counsel are responsible for ensuring that what is produced in discovery is both responsive and compliant.  Plaintiff must produce all responsive text messages and email communications, including the metadata and other accompanying information.  Plaintiff cannot skirt his responsibility to comply with his discovery obligations with vague allegations of undue burden or disproportionate cost.
  • Arnold v. Huntington Ingalls Inc., 2025 WL 2377664 (Mag. E.D. Va. May 30, 2025), adopted, 2025 WL 1879875 (E.D. Va. July 8, 2025).  Plaintiff violated an order to produce cellphone texts in a sequential, complete, and accurate manner.  Plaintiff’s haphazard compliance over an extended period shows bad faith.  Sanctions against pro se plaintiff to be determined.
  • Heym v. APG Housing, LLC, 2025 WL 1661414 (D. Md. June 11, 2025).  Plaintiffs ordered to produce responsive communications, including text messages and social media posts, concerning the house at issue and all injuries and losses.  The information is plainly relevant.
  • Pable v. Chicago Transit Authority, 145 F.4th 712 (7th Cir. July 28, 2025).  Monetary sanctions and ultimately dismissal of plaintiff’s suit with prejudice as a sanction for spoliation of ephemeral electronically stored information (Signal) affirmed.   Plaintiff’s explanation of the deletion “evolved over time,” justifying the trial court’s conclusion that the spoliation was intentional.  During discovery, plaintiff’s attorney attempted to hide the scope of the deletions.  In addition to his own sanctionable conduct, plaintiff was legally responsible for the conduct of the attorney he hired.
  • L.F. v. EF Educational Tours,  2025 WL 2777586 (M.D. Pa. Sept. 29, 2025).  Requests for social media information that supports, mentions, or contradicts a plaintiff’s allegations is relevant and discoverable.  Defendant is entitled to discovery of the minor plaintiff’s social media activity during the overseas trip where the alleged assault occurred.  Plaintiffs initially  misrepresented the existence of responsive electronically stored information.  Even after deposition testimony established regular texting, plaintiffs have not produced them.  Plaintiffs’ counsel refused to produce other ESI, and the results of his forensic extraction have proven to be incomplete.  An overseas trip with classmates and an alleged sexual assault, would usually entail an adolescent communicating with her peers and family.  Plaintiffs must produce all texts occurring during the trip and for a week before and after involving them or anyone involved with the trip.  Given past conduct, plaintiffs are further ordered to provide ISP authorizations for release of messages.
  • Koon v. Ricoh USA, Inc., 2025 WL 3022642 (Mag. D. Neb. Oct. 29, 2025).  Plaintiff’s actions cast doubt on his claim that he has no more unproduced text messages.  Text messages are routinely produced.  Either plaintiff can submit his phone to a forensic recovery vendor of his choosing, or the court will authorize the defendant to do so.  Plaintiff must also group text messages by person and conversation, with new consecutive bates numbers.  Defendant is entitled to redepose the plaintiff about newly produced text messages.
  • Oakley v. MSG Networks, Inc., 2025 WL 3041936 (Mag. S.D.N.Y. Oct. 31, 2025).  Defendant awarded over $600,000 in counsel fees and a spoliation inference against plaintiff for the unexplained deletion of all text messages from plaintiff’s phone for the relevant time period.
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As we’ve discussed before, Florida’s offer of judgment statute has real teeth. Under the Florida statute (Fla. Stat. § 768.79), a defendant can recover its costs and attorney’s fees if the other side rejects the offer and ultimately recovers 25% less than the amount of the offer.  The risk of paying the defendant’s attorney’s fees ought to be a meaningful deterrent to meritless claims.

In today’s decision, Jacob v. Mentor Worldwide LLP, 2025 WL 3134227 (M.D. Fla. Nov. 7, 2025) (rep. & rec.), the defendant made an offer of judgment under the Florida statute. But that didn’t deter the pro se plaintiff from pursuing her claim that a ruptured breast implant caused her to develop lupus-like symptoms.  As we blogged about here, following a lengthy and tumultuous procedural history, the defendant ultimately prevailed on summary judgment.  Prior to moving for summary judgment, the defendant made an offer of judgment of $3,500, which was the amount of its limited warranty for implant ruptures. After obtaining summary judgment, the defendant moved for its costs and attorney’s fees.    

Continue Reading Chomp Chomp – Taking a Bite with Florida’s Offer of Judgment Statute
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Back in April, we pondered whether the new judge in the Valsartan MDL would change things for the better.  In contrast to the Zantac MDL, which was established a year later and has proceeded on a very similar contamination theory, the first several years of the Valsartan MDL saw a bunch of bad rulings on preemption, class certification, state law predictions, and other issues.  The decision that prompted our musings involved the exclusion of the plaintiff’s economic expert in a third party payor bellwether case and showed how seriously the court took its gatekeeping responsibilities as emphasized in the 2023 revisions to Fed. R. Evid. 702.  We offered our hope that the court would reexamine preemption or, “[i]f that is a bridge too far, then other holes in plaintiffs’ case—at least while it is based on the mere assumption of dangerous contamination—should present real obstacles for the Valsartan MDL plaintiffs.”  Before we cause major soft tissue injury trying to pat ourselves on the back for our prescience, last week’s decision out of the Valsartan MDL that granted summary judgments to the defendants in “what was to be the first bellwether trial”—in a case selected by the parties—was not exactly as we forecast.  In re: Valsartan, Losartan & Irbesartan Prods. Liab. Litig., No. 19-2875, 2025 WL 3131002 (D.N.J. Nov. 10, 2025) (“Roberts”), excluded plaintiff’s sole specific causation expert based on her unreliable differential diagnosis (or, more accurately, differential etiology) because she lacked a reliable basis to rule in the medication use and rule out several other risk factors for plaintiff’s decedent’s liver cancer.  To plaintiff’s credit, he conceded that the exclusion of this expert would be fatal to his case; to the expert’s credit, she conceded that some of the steps in her causation analysis were “pure speculation.”  Id. at *2 & 21.  Still, this is a major win and affirmation that the proper Rule 702 standards should not yield to the needs of the plaintiffs in an MDL.

Decisions excluding specific causation opinions are often not as useful as decisions excluding a general causation opinion because the former involve a case-specific inquiry.  When the expert purports to form her specific causation opinion based on conducting a differential diagnosis, it can be even harder to extrapolate a decision excluding that opinion.  For us, the key part of Roberts is the ruling on the unreliability of the plaintiff’s expert’s ruling in of the prescription drug use as a substantial cause of the decedent’s liver cancer.  We will focus on that.  The court’s finding that the expert’s ruling out of the decedent’s various risk factors for liver cancer was unreliable is also worth reading and, as the court noted, would have been a sufficient reason to exclude her opinion.  Id. at *27 n.54.  Neither, at least according to the court, involved deciding general causation.  Id. at *3 n.5.  (The differences between general and specific causation blur when the focus is on issues such as the level of exposure needed to cause a disease or the specificity of the disease that the exposure can cause (e.g., cancer versus liver cancer versus hepatocellular carcinoma).)  The decedent in Roberts had such strong and established risk factors for the type of liver cancer he had that we can see why the defendants picked the case as a bellwether.  We speculate that the plaintiff lawyers assumed that Alabama’s law on causation would help them advance their argument that the prescription drug use was the final straw; they clearly liked that the Roberts decedent’s cancer diagnosis came soon after the product recall and that his remaining pills were apparently shown to have much higher levels of NDMA than FDA set as the maximum.  (The reliability of that testing, which is certainly not a foregone conclusion given the history of the litigation, was also not addressed.)  Regardless of how it got selected as a bellwether, Roberts teed up some classic causation issues that should impact other plaintiffs and experts in the MDL.

Roberts started with the affirmation that the 2023 amendment to Rule 702 “clarified that the preponderance standard applies to the three reliability-based requirements added in 2000—requirements that many courts have incorrectly determined to be governed by the more permissive Rule 104(b) standard.”  Id. at *6 n.11.  Placing the burden on plaintiff as the proponent of the expert evidence helped the Roberts court reject plaintiff’s arguments that his expert should get a pass based on the relatively few epidemiologic studies directly on-point, that the court should defer a ruling on admissibility until after the jury would have already heard the expert’s testimony, that the court was usurping the jury’s role, and implicitly that the evidence plaintiff needed to get to trial in an MDL bellwether case should not be excluded.  Throughout, the court cited cases over the thirty-two years since Daubert that have emphasized the gatekeeping role, the focus on methodology, and what reliable causation opinions need to be based on—in our view, the more convincing cases.  Fundamentally, plaintiff’s expert was unable to articulate how much NDMA from Valsartan is needed to cause the kind of cancer that plaintiff’s decedent had.  Id. at *25.  We do think this is fundamentally a general causation question, but it is also a key question for a reliable differential etiology—you cannot include a particular exposure on the list of potential causes unless the relevant level of exposure is known to be a cause.  This was essentially the issue in General Elec. Co. v. Joiner, 522 U.S. 136 (1997), which involved causation opinions about cancer and workplace exposure to alleged carcinogens.  Joiner did not expressly distinguish between general and specific causation or describe the plaintiff’s experts’ approach as differential diagnosis, but the issues analyzed in Roberts are very similar.  We see this return to Daubert and its early progeny, aided by the clear allocation of burden, as a good thing.

Roberts proceeded to analyze the three types of evidence that the expert claimed supported ruling in plaintiff’s decedent’s Valsartan use as a potential cause of his specific kind of liver cancer.  First were the studies that looked at human use of Valsartan and liver cancer, of which two reported a statistically significant increased risk.  One stated that “[c]ausation cannot be inferred” from its results and the other described its results as inconclusive.  Id. at *22.  The expert tried to jack up the very low relative risk calculations from these studies with a series of unfounded assumptions about exposure levels and dose-response relationships, which the court saw as unreliable.  When we say the relative risk calculations were low, we are reminded of an expert we saw at a number of trials a long time ago.  He liked to tell the jury about a simple attributable risk calculation he did to say what percentage of the injuries in an exposed population came from the exposure as opposed to other risk factors.  For these studies, using the same calculation, 86.2% and 89.3% of the exposed population in these studies did not get liver cancer from the exposure.  This is why Daubert II and Havner required epidemiologic studies with statistically significant relative risks greater than 2.0—i.e., greater than 50% on an attributable risk exposed calculation—to establish general causation.  That may be a little far afield, but the low risks in these studies could not be reinterpreted upwards.

The expert also tried to rely on an occupational exposure study, which the Zantac MDL judge had rejected as a basis for a reliable general causation opinion.  Roberts followed the reasoning in Zantac (discussed in detail here and taking in our nod for fourth best decision of 2022 here), which included that the study’s author said it “was not designed to assess NDMA exposure through an oral medication.”  2025 WL 3131002, *23.  The expert’s last hope was to blur the lines with animal studies on cancer with NDMA exposure.  She lacked a reliable basis to extrapolate from the animals to humans or to establish a dose-response relationship tying plaintiff’s decedent’s purported NDMA exposure to a level that was associated with liver cancer in the study animals.  Id. at *24-26.  We were pleased to see the old Soldo decision—which focused on the testimony of an expert whose deposition in the case was the first one we ever took—still being cited for how to evaluate medical causation opinions that are purportedly based on animal studies.  The Roberts expert’s opinions did not come close to the standards for a reliable causation opinion.  Plaintiff also pushed that the animal studies supported a rapid onset from NDMA exposure to the development of cancer, but that was both speculative and insufficient to make up for the big holes in the expert’s causation opinion.

As we noted above, the Roberts decision also includes detailed discussion of the expert’s methodologic failures in attempting to rule out alternative causes for the plaintiff’s decedent’s liver cancer.  There were many.  However, rather than recapping those, we return to the court’s rejection of plaintiff’s argument that the court should just let the expert testify and be subjected to “vigorous cross-examination,” before the court rules on admissibility:

This Court shall do no such thing. Given this Court’s serious concerns with Dr. Siddiqui’s testimony, this would amount to a total abdication of its gatekeeping responsibility. The entire purpose of Rule 702 is to keep unreliable expert testimony from ever reaching a jury. And for good reason. How could the Court ever “unring” the proverbial bell after the jury had listened to hours of unreliable expert testimony? The prejudice to Defendants would be insurmountable.

Id. at *12 (emphasis in original).  Any federal judge who still thinks that the Federal Rules of Evidence favor admissibility of expert testimony, that the proverbial tie goes to the runner, and/or that cross can cure any expert admissibility issues better have a good answer to the question posed in Roberts.

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Council for Responsible Nutrition v. James, 2025 WL 3165673 (2d Cir. Nov. 13, 2925), is a Second Circuit decision about a New York state restriction on the sale of certain dietary supplements to minors. This blog covers the case because the court’s decision includes a disturbing preemption holding.  This particular blogger covers the case because it addresses a recent matter of particular concern that has arisen in more and more cases — the extent to which the government can and should act as our food nanny. It also helps that the CRN case is a bit strange.

To begin with, the “James” named as a defendant is New York Attorney General Letitia James, who right now has at least one case that is probably causing her more worry than this one. CRN, the plaintiff, is a trade group representing the dietary supplement industry. CRN filed the lawsuit to enjoin enforcement of section 391-00 of the New York General Law, which prohibits selling dietary supplements to anyone under age 18 if the supplement is “labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building.”  CRN’s theory was that the statute violated the First Amendment’s free speech clause, was unconstitutionally vague, and was preempted by federal law.  The district court denied CRN’s motion for a preliminary injunction because CRN was unlikely to prevail on the merits, could not demonstrate irreparable harm, and showed no favorable balance of equities. The district court also dismissed CRN’s claims except for the First Amendment claim. The case went up to the Second Circuit. 

The Second Circuit affirmed the district court, holding that it had not abused its discretion in concluding that the plaintiff was unlikely to win on substance, there was no irreparable harm, and the public interest would not be served by an injunction. 

The free speech issue hinged on a commercial speech analysis under the Central Hudson test. The Second Circuit held that protection of minors’ health was a substantial government interest, that the statute directly advanced that interest because youth appeared to be misusing the supplements, and the statute was not overinclusive as it was reasonable for the Legislature to focus on the product’s marketing. The Second Circuit also held that requiring retailers to age-verify that purchasers were adults did not constitute compelled speech. In sum, the statute passed intermediate scrutiny for laws restricting commercial speech.  

The Second Circuit also held that CRN’s vagueness claim fell short of the burden of showing “that no set of circumstances exists” for which the law’s application would be unambiguous.  

Now we get to the preemption ruling.  We are not pleased. Why?  We are in the land of express food preemption in section 343-1(a) of the Food, Drug, and Cosmetic Act (FDCA), which provides that “no State or political subdivision of a State may directly or indirectly establish under any authority continue in effect as to any food in interstate commerce … (5) any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title.”  Section 343(r)(1), in turn, prohibits health-related claims regarding a product’s nutrients, while section 343(r)(6) makes certain exceptions for dietary supplements. That is pretty strong and clear preemption.  We might even call it “plain.” (Foreshadowing.)

As the Second Circuit saw it, the issue was whether the statute’s “age restriction, by being triggered by (among other things) a health claim made on a product label, is therefore a ‘requirement respecting’ such a health claim.”  The Second Circuit answered that question with a No, and how it got there is a little wobbly. Seemingly contrary to the Riegel  discussion of “requirement” always meaning the same thing in the FDCA (552 U.S. at 324, not even mentioned in the CRN opinion) the Second Circuit held that the meaning of “requirement” in the preemption clause of the food section of the FDCA is not “plain” and is therefore subject to narrowing under the presumption against preemption – notwithstanding the Supreme Court’s Franklin decision abolishing any presumption against preemption in express preemption cases.  According to the CRN decision, Franklin’s erasure of the presumption again preemption applies only if the statutory text is “plain.”  That seems to us to be sloppy, lazy reasoning. It is as if the Second Circuit was looking for an excuse to avoid the job of statutory interpretation. This approach seems to ignore, if not outright defy, Congressional  intent. 

Then, almost unbelievably, it gets worse.  The Second Circuit proceeds to lean on Bates (which is not even an FDCA case), to hold in CRN that incidental economic effects that “do[] not require a … maker to put anything in particular on a product label” do not count as “requirements.”  

After stumbling over the express preemption issue, the Second Circuit’s perfunctory treatment of the irreparable harm and public interest elements seems inevitable. Lost sales would not be irreparable harm and the industry pecuniary interests “pale in comparison to the State’s goal of protecting youth from products that unfettered access to dietary supplements present.”  It is hard to tell what is worse – the logic or the prose.  

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Defendants know that the quickest way to level an uneven playing field is to… well… sprint. And few procedural tools reward nimble defense work quite like snap removal—the perfectly valid act of removing a case to federal court before the forum defendant is served. Plaintiffs call it gamesmanship. We call it reading the statute. Yet even among defense counsel, one deceptively simple question can cause more anxiety than a late Friday notice of deposition: When is removal actually “effected”? Unfortunately, the answer to that question depends on what circuit you are in.

Some circuits hold that removal is effective the instant a defendant files the notice of removal in federal court. No muss. No fuss. No waiting for a plaintiff to check their email. Efficient, predictable, and refreshingly literal. The kind of interpretation that warms a defense lawyer’s heart. Other circuits insist that removal becomes effective only after the defendant (1) files the notice in federal court, (2) provides plaintiff with written notice of the removal, and (3) files a copy of the removal notice with the state court. See 28 U.S.C. §1446(d). This is the procedural equivalent of “measure twice, cut once,” except that by the time you finish measuring, the plaintiff has already handed the forum defendant a summons. The split feels like a Philosophy 101 question: If a defendant files a notice of removal in federal court, but no one in state court hears it, has removal really occurred? Apparently, depending on the circuit, the answer ranges from “Absolutely yes,” to “Absolutely no,” to “Why are you asking us? We didn’t write this statute.”

And here is the reason we are drawing your attention to the divide. Snap removal is already a race, but MDLs turn it into a triathlon. Because once a case is swept into an MDL, the governing procedural law is not the law of the circuit where the case originated—it’s the law of the circuit where the MDL sits. This cannot be overstated. Once the case is transferred, the MDL judge applies the MDL circuit’s law on procedural questions like removal timing. So, as defense counsel we need to be on high alert as to which law applies.

As the defendant in Spillman v. Philips, 2025 WL 3162000 (W.D. Pa. Nov. 12, 2025) found out. The case is part of the In re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation. Plaintiff was from Alabama. The defendants were all from Massachusetts.  Plaintiff filed in state court in Massachusetts. Before any of the forum defendants were served, the case was removed. Then, in chronological order, two defendants were served, plaintiff’s counsel received notice of the removal, and defendants filed the notice of removal with the state court.  Id. at *1.  And, before plaintiff’s motion to remand was heard the case was transferred to the MDL. So, the applicable law switched from First Circuit to Third Circuit.

The Spillman decision really does not address First Circuit law. So, we took a quick look and it does not appear that the First Circuit has addressed the specific issue of whether removal is effected at the time it is filed or only after notice to the plaintiffs and state court. However, we did find Berberian v. Gibney, 514 F.2d 790, 792 (1st Cir. 1975) that holds that “the jurisdiction of the federal court attaches as soon as the petition for removal is filed with it” (but that the state court retains concurrent jurisdiction until the notice is filed with it). Which we would argue favors removal being effective as of the federal filing. Unfortunately, the most recent decisions by courts in the Third Circuit favor removal requiring all three steps before it is effected.  Id. at *5-6. That is the law the court applied in remanding Spillman to state court.

Since our reason for this post is to advise defendants to know your circuits—plural—we also decided to poke around and see if we could give you a head start on that task. The following is not exhaustive, but we can report that there are few decisions on the specific issue as it relates to the snap removals. Adding to the First and Third Circuit law above, we found the following, which also demonstrate the divergent positions: Almonte v. Target Corporation, 462 F.Supp.3d 360, 365 (S.D.N.Y. 2020) (“In [the Second] Circuit, a federal court obtains jurisdiction when the notice of removal is filed with the federal court”); Burroughs v. Palumbo, 871 F.Supp. 870, 872 (E.D. Va. 1994) (finding federal jurisdiction attached when the removal petition was filed in federal court); Hamptom v. Union Pacific R. Co., 81 F.Supp.2d 703, 707 (E.D. Tex. 1999) (you need to complete all three steps before a removal is effected); Anthony v. Runyan, 76 F.3d 210, 214 (8th Cir. 1996) (“removal is effected when the notice of removal is filed with the state court and at no other time”). There are more decisions along these lines from other courts as well.

What does all this mean? Expect plaintiffs to push back. And expect courts to continue grappling with the split. Until the Supreme Court steps in (don’t hold your breath), inconsistency is part of the landscape. Snap removal is a tool that rewards being organized, proactive, and just a little faster than the other side. Knowing which circuit’s rule governs may be the difference between a case staying in federal court or being catapulted back into a plaintiff-friendly state venue. In short, defendants who understand the timing rules don’t just play the game. They control the tempo.

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As we’ve pointed out elsewhere, particularly in our duty to test cheat sheet, most states do not recognize any sort of separate negligence or strict liability claim for “duty to test” or “failure to test” separate and apart from the more usual sort of product liability claims involving the design and warnings of products.  So defendants looking to file motions to dismiss against testing-based counts of their opponents’ complaints could do worse than to check out our cheat sheet.

Manufacturers of FDA pre-market approved medical devices, however, have a second option.  They can also go after testing-based claims on preemption, because claims that manufacturers of such devices should have done more or different testing than the FDA considers necessary for approval are either “different from or in addition to” the FDA’s PMA criteria.  Indeed, the seminal express preemption case, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), recognized that express preemption under 21 U.S.C. §360k(a) extends to “tort law, applied by juries under a negligence or strict-liability standard,” such as state tort claims alleging “negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of [a PMA device],” id. at 320, although the dismissed testing claims were not separately discussed by the Supreme Court in Riegel.

Continue Reading PMA Preemption of Negligent Testing Claims
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Today’s guest post is by Howard Dorfman, a old friend of the Blog, who is now continuing to think important thoughts as an Adjunct Professor at Seton Hall Law School. This post concerns potential product liability implications of the FDA’s decision to release so-called “complete response letters (“CRLs”), apparently as a matter of future routine. We hadn’t written about that topic, and were more than pleased when Prof. Dorfman indicated his interest in doing so. As always, our guest posters deserve all the credit (and any blame) for their work.

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On September 4, the Food and Drug Administration (FDA) announced its intention to release future Complete Response Letters (CRLs) “promptly” following their being sent to drug sponsors. That day, the agency also released 89 previously unpublished CRLs issued from 2024 to the present related to pending or withdrawn New Drug Applications (NDAs) and other drug filing applications. According to the FDA, each of released CRLs details specific deficiencies in the drug filings relating to safety and efficacy identified by the agency that prevented approval of the application.

At the same time, the FDA released 89 new CRLs, adding to the more than 200 CRLs that were previously made public in July, ostensibly designed to allow third parties greater access to the reasoning behind the agency’s review process. However, the previous release of CRL letters only included rejection letters for drugs that were eventually approved. The September release represented the first time the agency had released such documents for non-approved drug submissions. Further, the FDA indicated it would henceforth release CRLs as they are issued, that is at the same time sent to the drug sponsors.

The September 4 pronouncement was not the first time FDA expressed its intentions regarding release of CRLs. On July 10, the agency announced its intention to embrace what it referred to as “radical transparency” by publishing more than 200 CRLs issued to a sponsor when it does not approve a New Drug Application, Abbreviated New Drug Application or Biologics License Application.

CRLs are official documents issued by the FDA to sponsors when the agency does not approve their submitted drug/biologic applications. It is important to recognize that a CRL is an intermediate step, not representing an outright rejection of the application. Rather, the CRL provides detailed feedback, often regarding safety, efficacy, or manufacturing issues, focusing the applicant’s attention on the application’s shortcomings and highlighting what would be needed for eventual approval.

CRLs often contain confidential and critical information regarding the feasibility of drug development, clinical trials, or manufacturing issues, including details that many companies choose not to publicly disclose. While the FDA touted its publication as a major “transparency” initiative, the 200 published letters did not reveal much to the public because they were for drugs that had already been approved. As a result, the relevant approval packages — including CRLs — were already publicly available and, in the end, only 22 of the 200 letters had not actually been published previously.

In the abstract, it is difficult to argue against greater transparency into government activities, particularly as pertaining to deliberations and decisions made that affect the availability of prescription drugs and biologics. However, the expansion of the process whereby CRLs are released has gone from limiting the release to CRLs for products that eventually obtained approval by the agency to those issued for submissions that have not yet been approved, including CRLs relating to applications that are voluntarily withdrawn or even abandoned. These latter documents had not previously been released by the agency, as it left to the discretion of the sponsor whether to communicate about rejected applications, including to indicate the reasons given for the rejection. Pharmaceutical companies generally release such information through press releases and/or in SEC-mandated filings.

It is well-established that pharmaceutical companies’ press releases can significantly increase their product liability exposure, particularly if the information can be characterized as false and misleading or failing to disclose important information. Historically, press releases have been considered a form of promotion and are subject to the same strict standards imposed by FDA regulations pertaining to promotional oversight by FDA for prescription drugs. 

The most significant issue impacting pharmaceutical companies’ liability is that immediate and unrestricted FDA release of all categories of CRLs is that the applicants have no time to react to the deficiencies that the FDA identifies. A successful regulatory response requires a thorough analysis of the FDA’s stated reasons presented for denial of marketing approval.  Such responses rarely can be developed and submitted to the agency within a relatively short period of time. In the interim, the CRL has been made public, where it can serve as an unwarranted imprimatur of FDA support for unsubstantiated causation allegations in future or current product liability litigation. The letters have the potential to serve as a source of expert opinion alleging product defect or company failure to undertake adequate clinical trials in support of their drug applications.

As recent litigation has shown, a CRL from the FDA can be a potent piece of evidence for plaintiffs’ experts in product liability litigation. By detailing what the FDA sees as deficiencies in an application, a CRL can support claims that a manufacturer failed to ensure a product was safe, effective, or properly manufactured before bringing it to market. Historically, plaintiffs’ experts have relied upon CRLs as a component of their testimony in litigation brought against a drug or biologic manufacturer.

Establishing evidence of a manufacturer’s negligence: Because CRLs frequently address deficiencies in the drug manufacturer’s manufacturing process, plaintiffs’ experts often use CRLs to make arguments that the manufacturer was aware of the product’s safety, efficacy, or quality issues and, despite this knowledge, continued to develop and sought regulatory approval. Moreover, an expert could compare the deficiencies cited in the CRL with the company’s public statements to investors in the form of press releases or in SEC-required disclosure documents or in its promotional materials and claim supposed discrepancies that in their opinion suggest negligence or fraudulent conduct.

Establishing causation: If a CRL documents a specific safety concern, identifies a problem in a clinical trial (such as criticizing its statistical analysis or sample size) or indicates the need to develop a robust Risk Evaluation and Mitigation Strategy (REMS) program, the applicant can expect to see expert reports parroting those statements as opinions that the individual or collective failures cited in the CRL were the most likely cause of the resulting injury.

Manufacturing defects: CRLs frequently cite deficiencies related to “Current Good Manufacturing Practices” (CGMPs), such as insufficient process validation or problems at a manufacturing facility. Even when such problems have been corrected, an adverse manufacturing expert witness can be expected to reference these findings to support a claim that the product was negligently made, which could have led to contamination or other harmful issues.

Labeling and “Failure to warn” claims: Labeling issues are frequent reasons for a CRL. A plaintiff-side expert will utilize labeling issues in a CRL to make claims that the manufacturer’s initial labeling was inadequate and failed to provide proper warnings about the product’s potential risks. The failure to warn allegations would no doubt follow the drug, beginning with approval process through marketing and throughout the product’s life cycle.

Of course, the defense will counter that notwithstanding statements made in a CRL, the most significant and definitive response to any allegations made by the plaintiff’s expert remains the fact that the reasons for the CRL were fixed, as demonstrated by the FDA’s eventual approval of the application. Final FDA approval, after any CRL problems were corrected, provides the most definitive evidence that the product is indeed safe and effective. Nonetheless, plaintiffs can – and do − point to the existence of a CRL to raise questions regarding the agency’s initial concerns with the product’s application and the approved product, thereby indicating that the company’s initial submission upon which the subsequent filing was based, was flawed and open the application and the approval process to scrutiny and remains relevant.

It is impossible to foresee how a trial or appellate court will view these arguments at the pretrial, trial and appellate levels – but the ongoing Fosamax litigation underscores how different courts have reached different conclusions about the same CRL.

Summary

Transparency appears to be the new “mantra” for FDA as demonstrated by the updated and expanded policies developed pertaining to the CRL process. While most of the discussion has focused on the impact on its impact on SEC disclosures and SEC litigation implications, an overlooked and equally important consideration for pharmaceutical companies is the potential impact on product liability litigation. In these circumstances, mere disclosures already part of SEC disclosure obligations may be insufficient in mitigating liability exposure for the pharmaceutical developer. As “radical” disclosure expands, companies will have to focus on existing policies and procedures in numerous aspects of the internal drug review and approval process to limit, if not to avoid, this increased risk.

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We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption. 

Yes, we need a life, but let’s put that aside for the moment.

In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval deserve no deference—and indeed should be invalidated—because the Agency made the wrong call and Loper Bright says they should be ignored.  Further, according to plaintiffs, an invalid PMA means manufacturers cannot assert a preemption defense, and they are off to the races with their tort claims faulting the FDA-required warning label, the mandated device design, and the scrutinized and approved manufacturing process. 

Loper Bright does not allow plaintiffs’ lawyers to overturn an exercise of FDA discretion in carrying out its assigned function in deciding whether to grant a PMA or PMA Supplement. Loper Bright recognizes that “[w]hen the best reading of a statute is that it delegates discretionary authority to an agency, the role of the reviewing court” is pretty much limited to “ensuring the agency has engaged in reasoned decisionmaking.”  Loper Bright also says nothing about agency policymaking or factfinding, which get very deferential review.  (See our post here.)

But more than that, these plaintiffs’ lawyers have the whole thing entirely backwards.  Loper Bright doesn’t undermine express medical device preemption, it gives manufacturers and defense lawyers a chance to re-set and expand how medical device preemption works.

Loper Bright involved the National Marine Fisheries Service and a federal law from 1976 (the Magnuson-Stevens Fishery Conservation and Management Act) that had something to do with the Atlantic herring fishery.  Something about the herring needing paid chaperones?  Or maybe the fishing boats?  (We are trying to care about the details, and failing.) 

Anyway, the National Marine Fisheries Service had issued regulations based on its interpretation of the statute, and the question was whether the Supreme Court had to defer to the agency’s interpretation of that statute or not.  Given that it is called the Supreme Court, you will not be shocked to learn that the Justices on said court decided that, while it is fine for a federal agency to exercise its discretion when Congress has authorized it to do so, interpreting federal laws is the job of the federal courts and they do not need the agency’s help with that, thank you very much.

Stated another way, Loper Bright got rid of a rule (Chevron deference) which had required courts to defer to “permissible” agency interpretations of the statutes those agencies administer, even when the reviewing court read the statute differently.  It freed federal courts from having to pay heed to an agency’s interpretation of a federal statute, and allows them to figure out the statute’s meaning on their own.

Ok, now let’s look at another federal law from 1976:  the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, and in particular the express preemption provision for medical devices, 21 U.S.C. § 360k(a). 

The first Supreme Court decision to interpret Section 360k(a) is one of our all-time bottom ten cases, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  It is just a mess.  A plurality decision with no cogent rationale and conclusions that suggest the court perhaps forgot to read the statute it was interpreting.

How did Lohr get so off track?  Maybe it is because Lohr’s interpretation of 21 U.S.C. § 360k(a) was constrained by the FDA’s attempt to interpret that statute, 21 C.F.R. § 808.1(d). 

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), tells us that: 

In Lohr, a majority of this Court interpreted the MDA’s pre-emption provision in a manner “substantially informed” by the FDA regulation set forth at 21 CFR § 808.1(d)….That regulation says that state requirements are pre-empted “only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device.”

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Informed by the regulation, we concluded that federal manufacturing and labeling requirements applicable across the board to almost all medical devices did not pre-empt the common-law claims of negligence and strict liability at issue in Lohr. 

* * *

Even though substantial-equivalence review under § 510(k) is device specific, Lohr also rejected the manufacturer’s contention that § 510(k) approval imposed device-specific “requirements.”

Riegel, 552 U.S. at 322 (emphasis added).

What Riegel is telling us is that because the Supreme Court in Lohr relied on an agency interpretation of a federal statute, it issued a cockamamie opinion.  One that said that general federal requirements aren’t “federal requirements”, and that device-specific 510(k) review doesn’t impose device-specific federal requirements.  Lohr made little sense, because the Agency’s interpretation of the “federal requirement” part of the statute made no sense.

Compare that with how the Supreme Court in Riegel handled the “state requirement” prong of 21 U.S.C. § 360k(a) after it concluded it was not constrained by the Agency’s statutory interpretation of 21 C.F.R. § 808.1(d).  (Yes, the Court has been throwing shade at deference to agency statutory interpretation for some time.)

The particular question for the Court in Riegel was whether “state requirements” include only positive enactments (statutes or regulations) or “state requirements” also encompass duties imposed tangentially, by imposing liability through common-law tort claims.

The FDA’s regulation said that “state requirements” in the federal statute only meant laws or regulations, not tort claims.  But the Court in Riegel didn’t agree, so it ignored the regulation and interpreted the statute as it wished:

All in all, we think that [21 C.F.R.] § 808.1(d)(1) can add nothing to our analysis but confusion.  Neither accepting nor rejecting the proposition that this regulation can properly be consulted to determine the statute’s meaning; and neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally; the regulation fails to alter our interpretation of the text insofar as the outcome of this case is concerned.

Riegel, 552 U.S. at 329-30.

We would all have been better off if Riegel ignored all portions of the Agency’s statutory interpretation regulation, both this state requirement bit and the federal requirement bit that Lohr had mangled.

But now that Loper Bright is here, maybe federal courts can start the statutory interpretation process over again based in the text of 21 U.S.C. § 360k(a), and free from the shackles of Lohr as tainted by the misguided regulation.  Bexis certainly thinks so.

If express preemption analyses started with the language of the statute, and Riegel instead of Lohr,we could revisit the question of whether the 510(k) process imposes device-specific federal requirements (it does), particularly in its modern, more enhanced form.  And we could revisit the question of whether federal requirements are “federal requirements” even though they apply to all devices and not just a particular device (they do).

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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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