Posted: 26 Feb 2016 09:21 PM PST
By Jennifer D. Newberger –
Judge Royce Lamberth, a Senior Judge in the United States District Court for the District of Columbia and sitting by designation in the United States District Court for the Western District of Texas, is no stranger to First Amendment cases involving FDA. SeeWashington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (1999). More than 15 years have passed since he ruled that the restrictions in the FDA Modernization Act of 1997 (FDAMA) and FDA’s implementing regulations regarding distribution of off-label materials were unconstitutional.
On February 25, 2016, upon conclusion of the evidence in a criminal case styled United States v. Vascular Solutions, Inc., on which we previously posted here, Judge Lamberth charged the jury by instructing them on the relevant law. The case involves allegations that the defendants, a medical device company and its president, engaged in an unlawful off-label marketing campaign. The government’s superseding indictment alleged that the defendants engaged in a criminal conspiracy to violate the Federal Food, Drug, and Cosmetic Act (FDC Act), and committed four counts of selling misbranded medical devices.
After deliberating for one day, the jury came back with a verdict of “not guilty” on all counts for both the company and its CEO, Howard Root. Though we cannot know why the jury reached this verdict, Judge Lamberth instructed the jury by, in effect, reminding the jury that FDA’s ability to restrict speech that is truthful and not misleading is limited:
FDA has long stated that the dissemination of information about unapproved uses can be important for medical professionals, and so long as the information is distributed according to certain guidelines provided by FDA, FDA would not consider the information to be evidence of a new intended use. See FDA, Guidance for Industry, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices (Feb. 2014).
Importantly, however, FDA has stated that publications about unapproved uses must “[b]e distributed separately from the delivery of information that is promotional in nature” in order to fit within the “safe harbor” of the above-mentioned guidance document. Consistent with this position, FDA has traditionally taken the position that off-label promotion of a drug or device for a use that has not been cleared or approved by FDA is a violation of the FDC Act. In contrast, the Department of Justice (DOJ) has made a number of statements in other cases indicating that the law is not so clearly a black and white situation. See, e.g., United States v. Stryker Biotech, LLC, No. 09-cr-10330 (D. Mass. 2012), in which DOJ stated in a brief that “not all off-label promotion is a crime” and that “there is some off-label promotion that is not illegal.”
Judge Lamberth’s instructions to the jury seem more consistent with DOJ’s position in Stryker than FDA’s traditional view of off-label promotion. In the jury instructions, Judge Lamberth indicated that promotional speech itself would not be evidence of misbranding so long as the speech was solely truthful and not misleading. This position is consistent with a growing trend among courts to find that truthful and not misleading promotional materials may be distributed by a company without violating the misbranding provisions of the FDC Act. See, e.g., United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); Op. and Order, Amarin Pharma, Inc. v. FDA, No. 1:15-cv-03588-PAE (S.D.N.Y. Aug. 7, 2015) (see our previous posts here andhere). It is notable that the jury instruction states that in order to avoid violating the misbranding provisions, the speech must besolely truthful and not misleading. This suggests that if any portion of the company’s “speech” is not truthful or is misleading, it may result in a product being deemed to be misbranded.
In reading Judge Lamberth’s jury instruction, it is important to keep in mind that the court is not necessarily making a statement about charges the government could have brought but chose not to. For example, the court charged the jury based on the superseding indictment of December 2, 2015. That indictment did not contain an adulteration charge involving selling devices without an approved PMA (unlike the original indictment of November 13, 2014). Nevertheless, given the growing willingness of companies to challenge FDA’s regulation of off-label promotion, their success in doing so, and court decisions indicating that the distribution of truthful, non-misleading information about an unapproved use does not violate the misbranding provisions of the FDCA, DOJ and FDA must carefully consider how to proceed in bringing charges of off-label promotion.
Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation. Information on the conference is available here.
Judge Royce Lamberth, a Senior Judge in the United States District Court for the District of Columbia and sitting by designation in the United States District Court for the Western District of Texas, is no stranger to First Amendment cases involving FDA. SeeWashington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (1999). More than 15 years have passed since he ruled that the restrictions in the FDA Modernization Act of 1997 (FDAMA) and FDA’s implementing regulations regarding distribution of off-label materials were unconstitutional.
On February 25, 2016, upon conclusion of the evidence in a criminal case styled United States v. Vascular Solutions, Inc., on which we previously posted here, Judge Lamberth charged the jury by instructing them on the relevant law. The case involves allegations that the defendants, a medical device company and its president, engaged in an unlawful off-label marketing campaign. The government’s superseding indictment alleged that the defendants engaged in a criminal conspiracy to violate the Federal Food, Drug, and Cosmetic Act (FDC Act), and committed four counts of selling misbranded medical devices.
After deliberating for one day, the jury came back with a verdict of “not guilty” on all counts for both the company and its CEO, Howard Root. Though we cannot know why the jury reached this verdict, Judge Lamberth instructed the jury by, in effect, reminding the jury that FDA’s ability to restrict speech that is truthful and not misleading is limited:
It is also not a crime for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of a device. If you find that VSI’s promotional speech to doctors was solely truthful and not misleading, then you must find the Defendants not guilty of the misbranding offense.The first of the two sentences above was included in the government’s proposed jury instructions, provided to the court on January 7, 2016. Whether such a statement represents a change in position for the government depends largely on the context in which the government is speaking and the circumstances in which such information is distributed.
FDA has long stated that the dissemination of information about unapproved uses can be important for medical professionals, and so long as the information is distributed according to certain guidelines provided by FDA, FDA would not consider the information to be evidence of a new intended use. See FDA, Guidance for Industry, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices (Feb. 2014).
Importantly, however, FDA has stated that publications about unapproved uses must “[b]e distributed separately from the delivery of information that is promotional in nature” in order to fit within the “safe harbor” of the above-mentioned guidance document. Consistent with this position, FDA has traditionally taken the position that off-label promotion of a drug or device for a use that has not been cleared or approved by FDA is a violation of the FDC Act. In contrast, the Department of Justice (DOJ) has made a number of statements in other cases indicating that the law is not so clearly a black and white situation. See, e.g., United States v. Stryker Biotech, LLC, No. 09-cr-10330 (D. Mass. 2012), in which DOJ stated in a brief that “not all off-label promotion is a crime” and that “there is some off-label promotion that is not illegal.”
Judge Lamberth’s instructions to the jury seem more consistent with DOJ’s position in Stryker than FDA’s traditional view of off-label promotion. In the jury instructions, Judge Lamberth indicated that promotional speech itself would not be evidence of misbranding so long as the speech was solely truthful and not misleading. This position is consistent with a growing trend among courts to find that truthful and not misleading promotional materials may be distributed by a company without violating the misbranding provisions of the FDC Act. See, e.g., United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); Op. and Order, Amarin Pharma, Inc. v. FDA, No. 1:15-cv-03588-PAE (S.D.N.Y. Aug. 7, 2015) (see our previous posts here andhere). It is notable that the jury instruction states that in order to avoid violating the misbranding provisions, the speech must besolely truthful and not misleading. This suggests that if any portion of the company’s “speech” is not truthful or is misleading, it may result in a product being deemed to be misbranded.
In reading Judge Lamberth’s jury instruction, it is important to keep in mind that the court is not necessarily making a statement about charges the government could have brought but chose not to. For example, the court charged the jury based on the superseding indictment of December 2, 2015. That indictment did not contain an adulteration charge involving selling devices without an approved PMA (unlike the original indictment of November 13, 2014). Nevertheless, given the growing willingness of companies to challenge FDA’s regulation of off-label promotion, their success in doing so, and court decisions indicating that the distribution of truthful, non-misleading information about an unapproved use does not violate the misbranding provisions of the FDCA, DOJ and FDA must carefully consider how to proceed in bringing charges of off-label promotion.
Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation. Information on the conference is available here.
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