United States ex rel. Jefferson v. Roche Holding AG

489 F.Supp.3d 418

UNITED STATES of America, et al., EX REL. Thomas JEFFERSON, Relator,

v.ROCHE HOLDING AG, et al., Defendants.

Civil Action No.: GLR-14-3665

United States District Court, D. Maryland.

Signed September 28, 2020

Charles Neilson Curlett, Jr., Rosenberg Martin Greenberg, LLP, Baltimore, MD, Charles D. Moore, Pro Hac Vice, Halunen and Associates, Clayton D. Halunen, Pro Hac Vice, Susan M. Coler, Pro Hac Vice, Halunen Law, Minneapolis, MN, for Plaintiffs State of California, State of Colorado, State of Connecticut, State of Delaware, District of Columbia, State of Florida, State of Georgia, State of Hawaii, State of Illinois, State of Indiana, State of Iowa, State of Louisiana, State of Maryland, Commonwealth of Massachusetts, State of Michigan, State of Minnesota, State of Montana, State of Nevada, State of New Hampshire, State of New Jersey, State of New Mexico, State of New York, State of North Carolina, State of Oklahoma, State of Rhode Island, State of Tennessee, State of Texas, Commonwealth of Virginia, State of Washington, State of Wisconsin, Sealed Party.

Charles Neilson Curlett, Jr., Lauren McLarney, Rosenberg Martin Greenberg, LLP, Baltimore, MD, Alex Brown, Pro Hac Vice, Christopher Lee Gadoury, Pro Hac Vice, Jonathan Paul Wilkerson, Pro Hac Vice, W. Mark LaNier, Pro Hac Vice, the LaNier Law Firm PC, Houston, TX, Charles D. Moore, Pro Hac Vice, Halunen and Associates, Clayton D. Halunen, Pro Hac Vice, Gerald Charles Robinson, Pro Hac Vice, Susan M. Coler, Pro Hac Vice, Halunen Law, Minneapolis, MN, for Plaintiff Thomas Jefferson.

Matthew J. O'Connor, Pro Hac Vice, Krysten Rosen Moller, Pro Hac Vice, Matthew Fitzgerald Dunn, Patrick M. Phelan, Sarah A. Franklin, Pro Hac Vice, Covington and Burling LLP, Washington, DC, for Defendant Hoffmann-La Roche, Inc.

Krysten Rosen Moller, Pro Hac Vice, Matthew J. O'Connor, Pro Hac Vice, Patrick M. Phelan, Sarah A. Franklin, Pro Hac Vice, Covington and Burling LLP, Washington, DC, for Defendant Genentech, Inc.

MEMORANDUM OPINION

George L. Russell, III, United States District Judge

THIS MATTER is before the Court on Defendant Hoffmann-La Roche Inc.’s ("Roche") Motion to Dismiss Relator's Amended Complaint (ECF No. 72) and Relator Thomas Jefferson's Motion to Strike Exhibits A, C, D, E, F, G, H, I, and K to Defendant Roche's Motion to Dismiss First Amended Complaint and Related Factual Assertions and Legal Arguments (ECF No. 89).¹ The Motions are ripe for disposition, and no hearing is necessary. See Local Rule 105.6 (D. Md. 2018). For the reasons outlined below, the Court will deny both Motions.

I. BACKGROUND²

A. Tamiflu, FDA Approval, and the Strategic National Stockpile

In 1996, Gilead Sciences, Inc. created Tamiflu, an oral antiviral prescription drug, and licensed it to Roche under a Development and License Agreement.³ (Am. Compl. ¶¶ 4, 24, ECF No. 34). Roche subsequently marketed and sold Tamiflu as a seasonal influenza treatment. (Id. ¶ 26). On April 30, 1999, Roche filed a New Drug Application ("NDA") seeking a Food and Drug Administration ("FDA") indication for influenza ("flu") treatment. (Id. ¶ 38).

Roche's NDA came on the heels of the World Health Organization's ("WHO") flu pandemic guidelines ("WHO Pandemic Guidelines" or "Guidelines"). (Id. ¶¶ 30, 37). The Guidelines, issued on April 1, 1999, "strongly recommended that all countries establish multidisciplinary National Pandemic Planning Committees (NPPCs) responsible for developing strategies appropriate for their countries in advance of the next influenza pandemic." (Id. ¶ 31). The Guidelines included proposed measures aimed at reducing the spread and severity of—in addition to the hospitalizations and deaths resulting from—the flu, including "restricting travel and public gatherings, quarantine, vaccine development" and establishing "strategic stockpiles of an antiviral drug." (Id. ¶¶ 33–34). WHO recognized that preexisting flu treatments, specifically amantadine and rimantadine, were clinically proven to reduce the severity and duration of flu symptoms. (Id. ¶ 36). With this new pandemic market identified, Roche sought to position Tamiflu as a pandemic treatment. (Id. ¶ 37).

On October 25, 1999, Tamiflu received an FDA indication "for the treatment of uncomplicated acute illness due to influenza infection in adults." (Id. ¶ 38). However, the FDA concluded that clinical trial data did not support an indication that Tamiflu reduced the severity of flu symptoms or prevented hospitalizations, secondary bacterial infections, or mortality. (Id. ¶¶ 40–42).

In 2000, Roche submitted a supplemental NDA seeking an indication for flu prophylaxis and treatment indications for reduction of flu-related complications and hospitalizations. (Id. ¶ 43). The FDA concluded that Tamiflu only prevented people from developing symptomatic influenza and approved an indication for the prophylaxis of influenza in adults and adolescents thirteen years and older. (Id. ¶¶ 44–45). In doing so, the FDA also concluded that the clinical trial data did not support claims that Tamiflu prevented either asymptomatic influenza infection or viral transmission. (Id. ¶ 46).

Roche sought broader treatment indications consistent with the pandemic uses outlined in WHO's Pandemic Guidelines—i.e., lower respiratory tract infections and pneumonia—but the FDA rejected these treatment indications. (Id. ¶¶ 47–48). The FDA also challenged Roche's marketing statements regarding Tamiflu. Specifically, on or about April 14, 2000, the FDA sent Roche a cease-and-desist letter regarding claims that Tamiflu had "the power to stop the flu" and reduced the "duration of the flu by 31%," the "severity of influenza symptoms by 38%," and "incidence[s] of secondary complication (i.e., bacterial infections) by 45%." (Id. ¶ 140) (internal quotation marks omitted).

In addition to seeking broader FDA treatment indications, Roche published scientific journal articles touting Tamiflu's efficacy for pandemic uses. (Id. ¶¶ 71–84). For example, a February 14, 2001 article by Robert Welliver and others ("Welliver Article") asserted that Tamiflu prevented flu transmission within households, implying that the drug prevented person-to-person transmission even though the clinical data did not support that implication. (Id. ¶ 72). Another article, published July 29, 2003 by Laurent Kaiser and Frederick Hayden ("Kaiser Article"), reported a pooled analysis of ten clinical studies—nine of which were included in the original and supplemental NDAs that Roche submitted to the FDA—and purported to show that Tamiflu reduced flu-related respiratory complications as measured by antibiotic use and hospitalizations. (Id. ¶¶ 58, 76).

Contemporaneous with or shortly after these publications, Roche's CEO, medical director, and marketing team met with various health care agencies, including the Department of Health and Human Services ("HHS") and the Centers for Disease Control and Prevention ("CDC"), regarding Tamiflu's inclusion in the Strategic National Stockpile ("National Stockpile"). (Id. ¶ 85). Roche's efforts yielded favorable results, and Tamiflu was added to the list of drugs approved for the National Stockpile on August 1, 2003. (Id. ¶ 82).

In August 2004, HHS issued a draft Pandemic Preparedness and Response Plan ("Draft Pandemic Plan"). (Id. ¶ 87). The Draft Pandemic Plan incorporated representations that Roche made about Tamiflu in various scientific articles, including the Welliver and Kaiser articles, as well as a February 1, 2004 article by Frederick Hayden ("Hayden Article"), which claimed that Tamiflu prevented flu transmission within households, even though the data only showed that Tamiflu reduced the incidence of symptomatic influenza. (Id. ¶¶ 83, 86–91).

During an October 26, 2004 presentation, Roche informed HHS that Tamiflu could be used to treat influenza and to prevent infection, even though clinical data did not support the latter assertion. (Id. ¶ 92). Hayden made similar misrepresentations in an April 20, 2005 presentation to HHS’ Pandemic Influenza Working Group ("HHS Working Group"). (Id. ¶ 93). During that presentation, Hayden cited his 2004 article and the Welliver and Kaiser articles while arguing that Tamiflu reduced the spread, severity, complications, hospitalizations, and deaths related to flu infections. (Id. ). The presentations also included a PowerPoint slide discussing Tamiflu's ability to prevent transmission within households. (Id. ¶¶ 94–95).

Hayden's representations regarding Tamiflu's ability to prevent viral infections were echoed by Roche's medical director, Dominick Iacuzio. (Id. ¶ 96). During a May 26, 2005 legislative hearing, Iacuzio falsely testified that certain antiviral drugs, including Tamiflu, could be used as a prophylactic to prevent a flu infection. (Id. ).

When the HHS Working Group met again on July 19, 2005, it adopted recommendations for implementing a Pandemic Influenza Preparedness Plan, which included maintaining a minimum stockpile of approximately forty million flu treatments, ninety percent of which would consist of Tamiflu. (Id. ¶¶ 97–98). Its recommendations were forwarded to Cristina Beato, M.D., acting Assistant Secretary for HHS’ National Vaccine Program. (Id. ¶ 99). HHS’ final Pandemic Influenza Plan ("Final Pandemic Plan"), released November 1, 2005, referenced Tamiflu's ability to decrease duration of illness, viral transmission, pneumonia, and mortality. (Id. ¶¶ 100–06). The Final Pandemic Plan also cited the Kaiser Article in support of HHS’ belief that Tamiflu would reduce hospitalizations by at least fifty percent. (Id. ¶ 103).

On November 4, 2005, HHS Secretary Michael Leavitt presented the Final Pandemic Plan to the United States House of Representatives’ Committee on Government Reform. (Id. ¶ 108). On December 30, 2005, Congress passed PL 109-148 appropriating $3.3 billion for HHS’ flu pandemic planning—$731 million of which was designated for antiviral treatments. (Id. ¶ 109). Congress appropriated another...