Back in the bad old days of the Bone Screw litigation, we had to fight our way through a thicket of scurrilous allegations about how our clients supposedly promoted off-label use through continuing medical education seminars that the Bone Screw plaintiffs claimed were used to reward surgeons who regularly used our clients’ products with excessive speaker fees.  Back then – in the mid 1990s – the plaintiffs’ preferred avenues for asserting such allegations were state-law based:  negligence per se, fraud on the FDA, and conspiracy.  By the time that the infamous Franklin False Claims Act (“FCA”) decisions came down (United States ex rel. Franklin v. Parke-Davis,147 F. Supp.2d 39 (D. Mass. 2001), and United States  ex rel. Franklin v. Parke-Davis, 2003 WL 22048255 (D. Mass. Aug. 22, 2003)), we had won Buckman (and a lot of other things), so Bone Screw-related promotion allegations were never the subject of FCA litigation.

But the Bone Screw promotional allegations were close enough to what has been subsequently alleged ad nauseum in FCA litigation that we’ve followed similar FCA litigation ever since.  Today’s case, United States v. Gilead Sciences, Inc., 2025 WL 2627686 (E.D. Pa. Sept. 11, 2025), does not involve off-label use, but does involve allegations of kickbacks – through speaker programs and donations to charitable organizations.  We’re happy to say that the entire action was dismissed – on both sets of facts.  We’re even happier to recommend the discussion in Gilead as providing useful guidance for how pharmaceutical companies can manage both types of programs in compliance with applicable law.

The Gilead relator unsuccessfully alleged that the defendant operated Philadelphia speaker programs for its hepatitis C medications as some sort of reward/kickback for speakers to use its products.  Gilead concluded that this claim was bogus.  In operating its hepatitis C speaker program, the defendant:

• Utilized an educational method that was “a mainstay in the pharmaceutical industry.”
• Did not schedule any speaker programs until “after [its product] was approved” by the FDA.
• “Also held ‘unbranded’ speaker events intended to provide important education about the . . . disease state” itself.
• Had a written “Conduct Manual” providing that ‘[s]peakers must not be nominated or selected based on explicit or implicit understanding, hope, or desire that they will prescribe, purchase, or recommend [the defendant’s] products as a result of participation in the Speaker Bureau.”
• Required “ speakers [to] enter[] into contracts” with “a fee schedule and an hourly rate, which made clear that their payments did not take into account past or future prescriptions.”
• Used “a third-party vendor’s determination of fair market value” to calculate payments to speakers “based on based on their specialties and levels of expertise.”
• “Capped annual speaker compensation at $100,000.”
• Required that speakers be “trained on the [relevant] disease state, [its] products, and industry guidelines.”
• Required its “sales representatives . . . to receive compliance training.”
• “[M]onitored speaker programs internally” and with a third-party company, to follow “the quality of the presentation, the number of attendees, the use of sign-in sheets, the suitability of the venue, and adherence to spending limits.”
• Had a compliance department “headed by an attorney with experience in the pharmaceutical industry and staffed by 10 to 30 full-time employees.”

2025 WL 2627686, at *2-3, *13 (footnotes and internal quotation marks omitted).

On these facts, the defendant received summary judgment against the relator’s attacks on its hepatitis C speaker program, not due to any technical FCA defense, id. at *7-8, but because as a matter of law no legal violations existed.  “[D]espite years of discovery, [the relator] cannot point to evidence in the record − direct or circumstantial − that establishes that speaker programs focused on inducing and rewarding prescriptions by speakers.”  Id. at *8.  The defendant’s marketing plans “d[id] not lend themselves to a reasonable inference that any prescriber was chosen as a speaker because of their prescription volume or to induce prescriptions.”  Id. at *9.  “[T]he evidence establishes that [defendant] paid a fair market value for the speakers’ work, which indicates a lack of improper inducement.”  Id. at *10.  The relator did “not adduce[] sufficient evidence to create a dispute of material fact as to whether [defendant’s] speaker programs failed to provide relevant and genuine information about” the disease and its drugs indicated for its treatment.  Id. at *11.

[Relator] points to no evidence that [defendant’s] events “frequently exceeded” [its] official price cap. . . .  [T]he evidence does not show that [this] meal cap is so extravagant as to raise a triable inference that the meals were intended to induce prescriptions.  At most, [relator] has created a trivial dispute about the proper level of spending and the most appropriate locations for speaker events.  He has created no genuine dispute of material fact.

2025 WL 2627686, at *12.  In sum, the relator “has not adduced sufficient evidence to demonstrate that the speaker programs were a sham, with one purpose to induce physicians to write prescriptions.”  Id.

Nor did the relator in Gilead advance any basis for meeting the FCA’s causation requirement – given the “obvious” alternative reason that doctors prescribed these drugs because they worked:

[Relator] cannot overcome the obvious alternative explanation that speakers were exercising “sound medical judgment” by prescribing [defendant’s] newly available treatments. . . .  [Defendant’s drugs] had enormous advantages over prior . . . treatments in terms of efficacy and convenience.  Indeed, all eight medical providers deposed in this case testified that they chose to prescribe [the drugs] based on their sound medical judgment, not because of payment from the speaker program.

2025 WL 2627686, at *14 (footnote omitted),

The Gilead relator also unsuccessfully alleged that the defendant used charitable donations as illegal kickbacks to patients being treated with its drugs.  Gilead likewise concluded that those allegations were bogus based on the undisputed facts.  In making charitable donations, the defendant:

• Donated significant amounts to “an independent charitable organization that provide[d] financial assistance to patients living with life-threatening, chronic, and rare diseases for their out-of-pocket prescription and medication costs.”
• Selected a charity that was “one of the largest independent patient assistance programs in the United States,” that “has distributed over $4 billion to over 1 million patients.”
• Donated alongside “contributions from [other] pharmaceutical manufacturers, individuals, and other charitable foundations.”
• Donated to a charitable organization that limited “assistance to “patients [with] income within 400 to 500% of the federal poverty limit,” capped “maximum assistance . . . at $4,500 to $10,000 per year,” and required patients “to have insurance that covered the drug in question.”
• Donated to the charitable organization’s disease funds, that for the disease the defendant’s products treated, had a “formulary [that] included more than 20 drugs.”
• Donated more money than the charity spent for “assistance” to patients treated with its drugs.
• “[C]ompli[ed] with regulatory guidance provided by the Office of the Inspector General of [HHS] intended to provide information on how to provide assistance to patient assistance programs” consistent with anti-kickback laws.

2025 WL 2627686, at *3, 17 (footnotes and internal quotation marks omitted).

These facts, as well, supported summary judgment on the merits against plaintiff’s attacks on the defendant’s charitable contributions as somehow being kickbacks.

[Relator] cannot point to any evidence that [the charity] operated separate funds for [defendant’s drugs], or that [defendant] attempted to determine how much demand [the charity] would have for [its drugs] specifically and calibrated its donations to that demand.  Instead, the evidence in the record is that:  [Relator’s own] expert . . . admitted that “[defendant’s] donations to the . . . Foundation . . . were not specifically earmarked for [its] drugs;” [the relevant] fund provided assistance for numerous [other companies] medications; and [defendant] considered . . . requested donation amounts without evaluating the extent to which such donations may support [its drugs].

Id. at *15 (footnotes omitted).  Persons treated with the defendant’s drugs were only “a fraction of the total patients supported by [the charity].”  Id. at *16.  “The evidence simply does not support” the relator’s claim that the defendant “was manipulating its donations.”  Id.  Defendant’s drugs “completely revolutionized . . . treatment, allowing more patients to access, tolerate, and complete treatment,” thus the charity’s “assistance went to [users of these drugs] simply because [these drugs] had a significant market share.”  Id.  The relator “present[ed] no evidence that these donations were contingent on the [charity’s] agreement to purchase or recommend” the defendant’s drugs.  Id. at *17.  “The facts adduced in discovery support that [defendant] acted in accordance with [HHS] guidance and therefore did not have the requisite scienter to establish [a statutory] violation.”  Id. at *18.  In sum, once again the relator offered only “naked assertions, devoid of any evidence” that cannot survive summary judgment.”  Id. at *19.

Thus, the Gilead decision provides a good reference for how to administer a pharmaceutical speaker program and to conduct relations with independent charitable organizations that comply with the Anti-Kickback statute.  Since, as we discussed at the beginning, product liability plaintiffs are also known to attack these types of programs, Gilead is also relevant to our sandbox.  Future prescription medical product manufacturers can look to this decision for helpful guidance for how to run their programs properly.