United States ex rel. Bennett v. Bayer Corp.
| Decision Date | 31 March 2022 |
| Docket Number | Civil Action 17-4188 (ES) (JBC) |
| Parties | UNITED STATES OF AMERICA ex rel. CHARLES L. BENNETT, Plaintiff-Relator, v. BAYER CORPORATION, et al. Defendants. |
| Court | U.S. District Court — District of New Jersey |
NOT FOR PUBLICATION
In this qui tam action, Relator Charles L. Bennett sues Defendants Bayer Corporation and Merck & Co., Inc. (together “Bayer”), and Defendants Johnson & Johnson Johnson & Johnson Pharmaceutical Research & Development, and Ortho-McNeil-Janssen Pharmaceuticals (together, “J&J”). (D.E. No. 6, Amended Complaint (“Am. Compl.”)). Relator claims that Bayer and J&J violated the False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq., and similar state laws by misbranding two fluoroquinolones (“FQs”), thereby causing physicians to prescribe the drugs and seek reimbursement from government programs such as Medicare and Medicaid. (Am. Compl. ¶¶ 3-9). Bayer and J&J separately move to dismiss the Amended Complaint. (D.E. Nos. 38 & 41). Having considered the parties' submissions, the Court decides this matter without oral argument. See Fed. R. Civ. P. 78(b); L. Civ. R. 78.1(b). For the reasons set forth below, Defendants' motions are GRANTED. The Amended Complaint is dismissed without prejudice.
An FQ is an antibiotic that treats certain bacterial infections. Cipro and Levaquin are FQs. Cipro is manufactured by Bayer and is the brand name for ciprofloxacin. (Am. Compl. ¶¶ 4-5). Levaquin is manufactured by J&J and is the brand name for levofloxacin. (Id. ¶¶ 28 & 46). Both Cipro and Levaquin are part of billion-dollar industries. (Id. ¶¶ 45 & 47).
Relator claims that Cipro and Levaquin are misbranded. Specifically, he claims that their labels should disclose warnings that both may cause mitochondrial toxicity; Fluoroquinolone-associated Disability (“FQAD”); serious psychiatric adverse events; increased risk of Carbapenem-Resistant Enterobacteriaceae; and delayed adverse events. (Id. ¶¶ 67-89). He also alleges that the labels should explain to patients how to take Cipro and Levaquin, warn patients of the dangers of concomitant use of Levaquin and non-steroidal anti-inflammatory drugs, and warn patients that the clinical trials of Levaquin were flawed. (Id. ¶¶ 90-94). He bases these assertions on, among other things, scientific research and analysis that he and others, including Food and Drug Administration (“FDA”) officials, conducted.[1] Relator also points to FDA reporting.
First, Relator cites the FDA's pharmacovigilance review of systemic FQ exposure dated April 17, 2013. (Id. ¶¶ 7, 51, 57-58 & 67-68). That review was co-authored by FDA official Dr. Deborah Boxwell, and it identified “FQAD by using the FDA's reporting system through which doctors and patients can file complaints of adverse drug reactions.” (Id. ¶ 57). According to the review, FQAD exists “in patients who had (1) taken an FQ, including Cipro, as prescribed for uncomplicated sinusitis, bronchitis, and urinary tract infections, (2) suffered adverse reactions affecting ‘two or more body systems,' including peripheral nervous system, neuropsychiatric, musculoskeletal, senses, cardiovascular, and/or skin and (3) become disabled for 30 days or more.” (Id.).
Second, Relator points to the reporting system on which the April 17, 2013 pharmacovigilance review was based. That reporting system is known as “FAERS”-short for “FDA Adverse Events Reporting System.” (Id. ¶ 101). FDA regulations, Relator asserts, “require the manufacturer of any approved drug to submit to the FDA any adverse reaction events from an approved drug with[in] a certain time period: 1) An unexpected death within 24 hours; 2) An unexpected adverse event within 15 days; and 3) Any other adverse event on a quarterly basis.” (Id.). Relator alleges that the FAERS data for Cipro and Levaquin reported a significant number of adverse events-both psychiatric and neurological-that were not reflected on the drugs' labeling. (Id. ¶¶ 81-82, 103-04, 113 & 126). The FAERS data also, according to Relator, “clearly document[ed] that Cipro and Levaquin consumption [wa]s associated with FQAD.” (Id. ¶ 125). Relator alleges that the FAERS data further reported a significant number of deaths and “individuals damaged” after taking Cipro or Levaquin. (Id. ¶¶ 123-124).
Third, Relator cites two citizen petitions that he submitted to the FDA, asking the FDA to change the labeling of Cipro and Levaquin. He filed the first petition on June 18, 2014. (Id. ¶ 51). In that petition, he informed the FDA of his independent research of patient data-over 200 patients in total-of unlabeled adverse side effects after using an FQ. (Id. ¶¶ 50-51). He obtained that data through an independent pharmacovigilance program that he developed called the Southern Network on Adverse Reactions (“SONAR”). (Id.). He also offered his analysis of the April 17, 2013 pharmacovigilance review. (Id. ¶ 51). Relator filed the second petition on September 8, 2014. (Id.). In that petition, he informed the FDA of additional research and requested the FDA to review FQ labeling due to serious psychiatric adverse events not listed on the current labeling. (Id.). While Relator's petitions identified Levaquin, Relator believed that changing the label of one FQ would domino into changing the label of all FQs, including Cipro. (Id.). The FDA acknowledged receipt of his petitions approximately six months after the filing of each. (Id. ¶ 52).
Fourth, Relator cites his analysis of patient data that he submitted to the FDA on November 5, 2015, at the FDA Joint Meeting of the Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. (Id. ¶ 58). Relator's report “described 54 persons with long term FQ-associated toxicity identified by SONAR.” (Id.). Present at the meeting were nineteen patients, some of whom were part of Relator's research, who testified about the side effects they suffered after taking an FQ. (Id. ¶ 59).
Fifth, Relator points to an FDA briefing document for the November 5, 2015 meeting, in which the FDA found there was “an association between oral fluoroquinolone use . . . and the development of FQAD” and that “a description of the constellation of disabling adverse events is not currently described in the fluoroquinolone labels.” (Id. ¶ 75). The briefing document also, according to Relator, found some patients suffered from delayed adverse events after taking an FQ. (Id. ¶ 89).
Sixth, Relator cites his study, published in January or February 2016, that “combined a clinical study of 94 patients with an experiment utilizing C57BL/Mice.” (Id. ¶ 132; see also Id. ¶ 62). This “study was the first of its kind, ” according to Relator. (Id. ¶ 56; see also Id. ¶ 132).
Specifically, over a ten-day period, Relator administered different doses of Cipro to five sets of mice, leaving one group as a control group. (Id. ¶ 133). The results showed, among other things, according to Relator, “that mice treated with Cipro had lower grip strengths, reduced balance, and more depressive behaviors when compared with the controls.” (Id. ¶ 134). And the higher the dose, the more disparate the effect. (Id.). For the clinical study of human patients, “93 of the 94 human patients reported FQ-associated effects.” (Id. ¶ 135). Those patients suffered from “a range of psychiatric effects, ” including anxiety, depression, insomnia, panic attacks, brain fog and cognitive impairment, depersonalization, suicidal thoughts, psychosis and hallucinations, nightmare and abnormal dreams, impaired memory, emotional outbursts, and paranoia. (Id.). Many patients reported side effects not listed on the Cipro label. (Id. ¶ 136). This research “revealed significant Cipro toxicity and concluded that the current Cipro labeling is inadequate.” (Id. ¶ 137).
In addition to the above, Relator points to reporting on government websites to support his claim that Cipro and Levaquin are misbranded. Relator cites the website of the Centers for Disease Control and Prevention (“CDC”), in which the CDC advised the risk of Carbapenem-Resistant Enterobacteriaceae after taking an FQ. (Id. ¶¶ 87-88 & 114). Relator also cites the FDA's website advising that J&J's clinical trial of Levaquin had been flawed in certain respects. (Id. ¶¶ 93-94).
Relator further claims that he took his complaints to the public. He appeared in over 50 television news segments discussing his work and the alleged undisclosed and harmful side effects of FQs, including Cipro and Levaquin. (Id. ¶ 53). And he met, in early 2015, with staffers of various United States Senators. (Id.).
Relator alleges that, due to safety concerns for Cipro and Levaquin, the FDA has required Bayer and J&J to change the labels to reflect previously undisclosed side effects. (Id. ¶¶ 48 & 63- 65, 76-79, 83-86, 127 & 129). The FDA did so in 2006, in May and July 2016, and in July 2018. (Id.). Relator also points to a “non-binding FDA vote recommending that Defendants' current labeling is not adequate.” (Id. ¶ 8). Though it is not clear from the Amended Complaint, Relator appears to allege that the non-binding vote was taken at the November 5, 2015 meeting described supra, section I.C. (Id. ¶¶ 74 & 110).
However, Relator does not allege that Bayer or J&J failed to comply with any change in labeling. Nor does Relator allege that the FDA ordered Bayer and J&J to change the labels of Cipro and Levaquin to include what Relator now believes ought to have been included.
Relator claims that Bayer and J&J knew or should have known that they should include Relator's proposed...
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