A whistleblower’s False Claims Act (FCA) suit in the Eastern District of California has caught the attention of the Pharmaceutical Research and Manufacturers of America (PhRMA) and subsequently the Department of Justice, both of whom have filed amicus curiae briefs in the federal court. PhRMA re-responded to DOJ just last week, underscoring the case's importance. See that response here: PhRMA-Brief-Solis-v-Millennium.
Frank Solis, a former sales rep at Schering-Plough (now part of Merck) and Millennium Pharmaceuticals, alleged that the two manufacturers illegally marketed the heart medication Integrilin for unapproved off-label uses in violation of the Federal Food, Drug, and Cosmetic (FDCA). Had the government known that the companies "caused procurement for Integrilin for off-label uses," they "would not have provided reimbursement for such prescriptions,” the complaint states. “This course of conduct violates the False Claims Act.”
Notably, the government did not join in the case. This did not stop the whistleblower from moving forward, which has been a trend lately with relators who are winning cases after the government declines to intervene.
The defendants responded that off-label speech does not equate to a violation of the FCA. Because Medicare and Medicaid recognize that off-label uses are often medically appropriate and fully reimbursable, the defendants argue, Solis incorrectly conflated all off-label uses for Integrilin as completely ineligible for government reimbursement.
Solis's complaint states that Integrilin was not approved for patients with STEMI (ST-Elevation Myocardial Infarcation)--a serious type of heart attack caused by sudden complete blockage of a heart artery. Some examples used in Solis’s complaint as evidence that the companies wanted to “induce physicians to prescribe off-label” were:
- Schering managers and Medical Science Liaisons (MSLs) gave sales reps materials from a 2006 study supported by a Schering grant and published in the American Heart Journal that stated STEMI patients who received off-label Integrilin early in the emergency department had improved blood flow.
- Millennium Managers and MSLs gave sales reps materials from a 2001 study in the America Journal of Cardiology that stated STEMI patients that received off-label Integrilin early prior to primary Percutaneous Coronary Intervention (PCI) had improved blood flow.
- Schering managers and MSLs gave sales reps materials from: (1) a 2007 study in the journal Cardiology that claimed STEMI patients who received either Integrilin or ReoPro (another heart drug) had similar outcomes; (2) a 2007 study in the journal Mayo Clinic Proceedings that claimed STEMI patients who received either Integrilin or ReoPro had similar outcomes; (3) a 2008 study in the Journal of the American College of Cardiology found that Integrilin patients had fewer episodes of gastrointestinal bleeding than ReoPro.
- Per the complaint: “Despite the lack of a true protective or restorative effect by Integrilin in STEMI and early emergency department patients, Defendants trained and instructed its sales reps on every sales call to promote the drug as superior to competing drugs if used early during patient administration,” despite a “2009 study in the New England Journal of Medicine that showed that Defendants never should have sold Integrilin…because the drug failed to show improved outcomes compared to less expensive later treatment.”
PhRMA took serious issue with the First Amendment issues the case raises, and filed a "friend of the court" brief asking the court to reject the whistleblower's arguments. To PhRMA, it is incorrect to argue that a drug manufacturer's truthful speech about an unapproved use of an FDA-approved drug violates the False Claims Act solely because a different law, the FDCA, makes it illegal for drug manufacturers to promote drugs for unapproved uses.
“This case raises serious First Amendment concerns,” states PhRMA, “because relator’s and the United States’ construction of the [FCA] imposes liability on manufacturers for engaging in truthful speech about “off-label” uses of their drugs, i.e., particular uses of an FDA-approved medication that the FDA has not yet approved.”
PhRMA’s brief states that neither the plaintiff nor the government alleges that the speech “at issue here relaying reprinted articles about unapproved uses of the drug Integrilin from peer-reviewed journals, and summarizing the results of clinical trials was false or misleading.”
This interpretation, PhRMA believes, is contrary to both Sorrell v. IMS and Caronia v. U.S., which held that "the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug."
Thus, PhRMA argues that the court should: "[a]dopt one of the many plausible interpretations of the FCA and/or the FDCA that would avoid this constitutional problem." This woud include construing the FDCA as "prohibiting, at most, only false speech." Alternatively, the court "could hold that purported violations of the FDCA for promoting an unapproved drug cannot be a predicate for FCA liability, because such FDCA violations are independent of the FCA and cannot render a claim 'false.'"
PhRMA also argues that "[t]he United States puts a different spin on when a manufacturer’s truthful speech about unapproved uses of FDA-approved drugs may trigger FCA liability, but the government’s interpretation fares no better under the First Amendment." The government's interpretation, PhRMA argues, is that "manufacturers’ truthful speech to physicians about unapproved uses will often make manufacturers liable for “knowingly...caus[ing]” a false claim “to be presented” for reimbursement." So long as it is “reasonably foreseeable that [manufacturers’] conduct or statements would influence the submission of  false claims” for reimbursement, manufacturers may be liable for inciting such unlawful conduct,” the brief states.
This case is particularly important to PhRMA's battle for First Amendment protection, and their brief walked through how attenuated a manufacturer's speech was from the submission of a "false claim":
“The manufacturer’s speech as set out in the Complaint falls far short of expressly advocating the submission of false claims...The manufacturer did not tell physicians that prescriptions for the unapproved use at issue were reimbursable under Medicare...Nor did the manufacturer urge physicians to seek reimbursement for ineligible prescriptions. Quite the contrary: the manufacturer accurately disclosed that the unapproved use was not FDA-approved…All the manufacturer here allegedly did was circulate reprints of peer-reviewed journal articles and relay accurate summaries of clinical tests.”
“Physicians who received the reprints or other information from the manufacturer in this case received precisely the type of educational information that a trained physician would wish to receive about his patients. Physicians were not only free to disregard these reprints; their Hippocratic Oath obligated them to use their own, independent medical judgment as to whether a given prescription was warranted. And after those physicians prescribed the FDA-approved drug for an unapproved use, hospitals then made additional, independent determinations whether the prescriptions were reimbursable. Only after that did hospitals submit claims to the government.”
“In sum," PhRMA argues, “the remote and highly attenuated link between the manufacturer’s truthful speech and the hospital’s ultimate decision to submit a reimbursement claim make this the quintessential case where imposing liability would raise serious First Amendment issues.”
DOJ Response to PhRMA Brief
"Nothing in PhRMA’s brief establishes any violation of the First Amendment," the DOJ states in its brief. "[T]he False Claims Act  does not impose liability for speech, in and of itself. Thus, off-label promotion by a manufacturer is not by itself a violation of federal law. The promotion of an approved drug for an unapproved use, without more, does not violate the False Claims Act, nor is it among the comprehensive list of prohibited acts in the [FDCA]."
The DOJ's position is that the "FDCA prohibits misbranding of a drug" and the "FCA imposes liability for knowingly submitting false claims for payment, or causing others to do so." They state that for the FCA, "off-label promotional activity can be evidence of how a defendant caused the submission of false claims or its scienter." (emphasis added). PhRMA argues that "[u]sing evidence of off-label marketing in this way does not run afoul of the First Amendment."
"It is important to make clear precisely what PhRMA, like the defendants in this case, contends that the First Amendment provides: a constitutional right to knowingly cause other parties to submit false claims to the government, as long as a party does so by its speech. This radical position has never been endorsed by any court and is not supported by any precedent."
The DOJ uses two examples in an effort to argue against PhRMA's assertion that manufacturers are being punished for speech alone: antimonopoly laws where collusion often takes the form of speech, and criminal conspiracy laws where pre-crime conversation is often used as evidence.
DOJ's brief boils down to this: "speech that serves as a conduit for violations of the law is not constitutionally protected."
PhRMA Responds Again
Just last week, PhRMA responded to DOJ's brief: PhRMA-Brief-Solis-v-Millennium.
PhRMA reiterated their position: "For a party’s speech to 'knowingly caus[e]' someone else to submit a false claim under the [FCA], the First Amendment demands a direct causal nexus between the speech and the claim." PhRMA states that such a "nexus is absent" when sales reps give doctors truthful, often critical, studies about off-label uses for certain drugs, and then the doctor exercises their medical judgement and prescribes the drugs to treat patients.
"The speech at issue does not urge or instruct others to submit false claims," PhRMA states. "All the manufacturer did was share with doctors copies of medical articles published in leading peer-reviewed journals discussing an unapproved use of an FDA-approved drug. It is undisputed that this speech is truthful."
While DOJ doesn't address the importance of certain off-label uses in practes, PhRMA notes that such information is "so central to the practice of modern medicine that doctors may thwart the standard of care if they do not prescribe FDA-approved drugs for unapproved uses that would be appropriate for the patient."
According to PhRMA, under the government's view, a manufacturer could be liable for knowingly causing the submission of a false claim (and thus treble damages under the FCA) if it is only "reasonably foreseeable" that a manufacturer's statements would influence the submission of a claim ineligible for payment,
PhRMA states that "[t]aken to its logical conclusion, the government’s interpretation has no rational stopping point" and would "open the floodgates to FCA liability for virtually anyone in the medical field." This would include fellows, patient advocacy groups, insurance companies, and "medical journals themselves," who "all foreseeably distribute the same information to doctors as manufacturers do." PhRMA notes that "[t]hey all would be just as liable for inciting false claims under the government’s stated theory."
In distinguishing truthful off-label speech from the DOJ's assertion that speech is used as evidence in several crimes, PhRMA stated: "[s]peech aiding and abetting a crime is an instrument of the crime and actively 'assist[s] the perpetrators.'” The DOJ "disturbingly sees a 'precise analog[ue]' between the 'dissemination of printed materials that incite crimes' and 'civil liability for causing another party to submit false claims...via the dissemination of printed materials,'” PhRMA argues.
"But disseminating medical journal articles about clinical trial results at most may encourage others to engage in conduct that is lawful—and beneficial to public health and patient care. If doctors decide, based on their medical judgment, to prescribe drugs for unapproved uses, that is legal and what doctors should do under their Hippocratic Oaths." (emphasis added).
This will be a very important case to watch, and we will be following it closely.