We weren’t expecting to find anything bloggable when we reviewed the Supreme Court’s recent unanimous decision in Smith & Wesson Brands, Inc. v. Estados Unidos Mexicanos, ___ U.S. ___, 2025 WL 1583281 (U.S. June 5, 2025).  But we were struck by the familiarity of the allegations of illegal marketing that the Court in S&W held could not be passed off as “aiding and abetting.”  These were the same tired and repetitive allegations of purported “illegal marketing” by independent actors in the distribution chain that we have seen in so many drug/device cases – sometimes masquerading as “public nuisance.”

We think our clients can use S&W against such allegations, at least by analogy.

Briefly, an independent nation, Mexico, thought it would be a bright idea to sue various manufacturers of firearms in a civil suit, claiming that the manufacturers were liable, on an “aiding and abetting” theory, for gun violence in Mexico.  These allegations were advanced as “aiding and abetting” because of a preemptive statute, the Protection of Lawful Commerce in Arms Act, that had a “predicate exception” capable of being satisfied by “aiding and abetting someone else’s firearms offense.”  Id. at *4.

Scrubbing allegations of firearms-specific facts, the plaintiff claimed:

• The defendant manufacturers were “willful accessories” to unlawful sales of their products by retail dealers, that in turn enabled their customers to acquire and use those products illegally.
• The defendants supplied their products to retail dealers whom they knew illegally resold to some customers.
• The defendants used a multi-tier distribution system, selling to wholesalers, who sold to retail dealers, who resold to customers.
• A small minority of the retailers were responsible for most of the harmful sales, which often violated federal laws.
• The defendants knew who the rogue retailers were and that they engaged in prohibited practices, but to boost profits they continued to supply those retailers.
• By choosing not to stop selling their products to known rogue retailers, the defendants became liable for the rogue retailers’ illegal conduct.
• The defendants could have, but did not, imposed restraints on their supply chains that would have prevented illegal sales.
• They could have prohibited others from making bulk sales of their products to individual customers.
• They could have prohibited dealers from retailers from selling products in ways that tend to ignore regulatory requirements.
• More generally, the defendant manufacturers could have implemented processes for monitoring or supervising their retailers’ sales practices, that would have minimized the retailers’ illegal sales.
• Product design and marketing was adapted to appeal to potential illegal users of their products.

S&W, 2025 WL 1583281, at *4-5 (citations and quotation marks omitted). 

These kind of allegations are no different than many attempts that we’ve seen for years to hold drug and device manufacturers liable for purported downstream misconduct – going back to the off-label marketing claims made in the Bone Screw litigation, and currently continuing with various “public nuisance” claims.

Along the way, we have seen a few claims, almost entirely unsuccessful, against drug/device manufacturers framed as “aiding and abetting.”  See In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753, 781 (5th Cir. 2018) (aiding and abetting not a separate tort) (applying Texas law); In re McKinsey & Co., Inc. National Prescription Opiate Consultant Litigation, 2023 WL 4670291, at *9 (N.D. Cal. July 20, 2023) (aiding and abetting claim dismissed for lack of any wrongful act); Angell v. Allergan Sales, LLC, 2019 WL 3958262, at *16 (M.D. Fla. Aug. 22, 2019) (claim dismissed for failure to plead “actual knowledge”); DePuy Synthes Sales, Inc. v. Globus Medical, Inc., 259 F. Supp.3d 225, 242 (E.D. Pa. 2017) (dismissing claim for “aiding and abetting a breach of fiduciary duty”); In re Arizona Theranos, Inc., Litigation, 256 F. Supp.3d 1009, 1036-37 (D. Ariz. 2017) (claim not pleaded with particularity); Simons v. Boston Scientific, 2017 WL 5951701, at *11 (D.N.J. Nov. 30, 2017) (claim dismissed for lack of any wrongful act), aff’d, 765 Fed. Appx. 773 (3d Cir. 2019); Plumbers’ Local Union No. 690 Health Plan v. Apotex Corp., 2017 WL 4235773, at *11 (E.D. Pa. Sept. 25, 2017) (same); Zafarana v Pfizer, Inc., 724 F. Supp.2d 545, 560 (E.D. Pa. 2010) (aiding and abetting not a separate tort).  S&W reinforces that “aiding and abetting” is not a cause of action readily available to civil litigants in cases involving legal products:

[R]esponsible manufacturers might well impose constraints on their distribution chains to reduce the possibility of unlawful conduct. . . .  So too, those manufacturers might decide, . . . to themselves monitor dealers’ sales for law violations. But a failure to do so is . . . passive nonfeasance − a failure to stop independent retailers downstream from making unlawful sales.  Such omissions and inactions, especially in an already highly regulated industry, are rarely the stuff of aiding-and-abetting liability.

S&W, 2025 WL 1583281, at *8 (citations and quotation marks omitted) (emphasis added).

In S&W, the Supreme Court held that that the plaintiff’s allegations didn’t come close to a cause of action.  “[S]everal ancillary principles” required far more specific pleading than plaintiff’s broad-brush allegations.  Id. at *6.  Most importantly, “routine and general activity that happens on occasion to assist in a crime − in essence, incidentally − is unlikely to count as aiding and abetting.”  Id. at *6 (citation and quotation marks omitted).  Absent an “independent duty to act,” a person’s “failure[s],” “omissions,” or “inactions” − even if in some sense blameworthy − will rarely support aiding-and-abetting liability.” Id. (citation omitted).  “[A]iding and abetting is most commonly a rule of secondary liability for specific wrongful acts.”  Id. (citation and quotation marks omitted) (emphasis original).

Put together, these holdings establish that a manufacturer’s mere knowledge that illegal sales occur doesn’t result in liability for aiding and abetting:

[The] complaint does not plausibly allege that the defendant manufacturers aided and abetted [retailers’] unlawful sales. . . .  We have little doubt that, as the complaint asserts, some such sales take place − and that the manufacturers know they do.  But still, [plaintiff] has not adequately pleaded what it needs to: that the manufacturers participate in those sales as in something that they wish to bring about, and seek by their action to make succeed.

S&W, 2025 WL 1583281, at *7 (citations and quotation marks omitted).  Non-specific allegations set a “high bar” for pleading.  Id.  “[G]eneral accusation[s] that all the manufacturers assist some number of unidentified rogue [retailers] in making a host of [product] sales in violation of various legal bars . . . must be backed by plausible allegations of pervasive, systemic, and culpable assistance.”  Id. (citation and quotation marks omitted).  This logic means that the kind of broad, vague allegations attempting to charge drug/device manufacturers with responsibility for supervising their entire distribution chains should get TwIqballed after S&W.

Specifically, allegations that defendant manufacturers make product sales to allegedly “known” bad actor intermediate sellers:

fail[] to clear that bar, for a package of reasons. . . .  [I]t is far from clear that such behavior, without more, could ever count as aiding and abetting under our precedents. . . .  [T]he complaint repeatedly states that the manufacturers treat rogue [retailers] just the same as they do law-abiding ones − selling to everyone, and on equivalent terms.  So the complaint, even if taken at face value, would stretch the bounds of our caselaw.

Id. (citations omitted).

Critically, under the TwIqbal pleading standard, generalized allegations of tolerating illegal product sales by others in the chain of product distribution cannot be “take[n] . . . at face value,” since they are not “plausible”:

Given [the] industry structure, [plaintiff’s] complaint must offer some reason to believe that the manufacturers attend to the conduct of individual [retailers], two levels down.  But it does not so much as address that issue.  And even assuming the manufacturers know everything the distributors know, the complaint still would not adequately support the charge that they have identified the bad-apple [retailers].  [Plaintiff] does not itself name those dealers, though they are the ostensible principals in the illegal transactions claimed.  Nor does [the complaint] provide grounds for thinking that anyone up the supply chain − whether manufacturer or distributor − often acquires that information.  Indeed, the complaint points out that government agencies only sporadically provide upstream companies with information. . . .  So [plaintiff’s] allegation on this score is all speculation; even on a motion to dismiss, it is not enough.

Id. (emphasis added).  These pleading-related comments in S&W are not specific the aiding and abetting cause of action.  Rather they are a discussion of general TwIqbal standards.

Thus, everything S&W observes in dismissing the manufacturer-related claims in that case are likewise true of the generalized off-label promotion or controlled substance allegations we see in our litigation that likewise seek to hold manufacturers liable for purported improper drug/device sales throughout the equally layered system for distribution of prescription medical products.  “A manufacturer of goods is not an accomplice to every unaffiliated retailer whom it fails to make follow the law.”  Id. at *8.  Defense counsel should use S&W to seek dismissal of similarly vague global allegations against drug and device manufacturers whether called “aiding and abetting,” “public nuisance,” “illegal marketing,” “negligence per se,” or any other purported cause action making similar accusations against product manufacturers.