Aston v. Johnson

• Decision Date: 31 March 2017
• Docket Number: Civil Case No. 16-0086 (RJL).
• Citation: 248 F.Supp.3d 43
• Parties: Terry ASTON, et al., Plaintiffs, v. JOHNSON & JOHNSON, et al., Defendants.
• Court: U.S. District Court — District of Columbia

248 F.Supp.3d 43

Terry ASTON, et al., Plaintiffs,

v.JOHNSON & JOHNSON, et al., Defendants.

Civil Case No. 16-0086 (RJL).

United States District Court, District of Columbia.

Filed March 31, 2017

Larry E. Klayman, Freedom Watch, Inc., Washington, DC, for Plaintiffs.

Michael M. Maya, Covington & Burling LLP, Washington, DC, Jonah Knobler, William F. Cavanaugh, Jr., Patterson Belknap Webb & Tyler LLP, New York, NY, Anthony Joseph Jay, III, Kenneth Leonard Wainstein, Cadwalader, Wickersham & Taft LLP, Washington, DC, Lauren A. Moskowitz, Roger G. Brooks, Cravath, Swaine & Moore LLP, New York, NY, Alexandra M. Walsh, Beth A. Wilkinson, Wilkinson Walsh + Eskovitz, PLLC, Washington, DC, for Defendants.

MEMORANDUM OPINION

(March 30, 2017) [Dkts. # 22, # 23, # 24]

RICHARD J. LEON, United States District Judge

Terry Aston, John Fratti, Linda Martin, David Melvin, and Jennifer Wilcox (collectively, "plaintiffs"), bring this twenty-two count action against three sets of defendants: Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, LLC, and Ortho–McNeil–Janssen Pharmaceuticals, Inc. (the "J & J defendants"); Renaissance Technologies, LLC, Peter F. Brown, Robert L. Mercer, and James H. Simons (the "Renaissance defendants"); and Dr. Margaret L. Hamburg, former Commissioner of the U.S. Food and Drug Administration ("FDA"), in her individual capacity. Plaintiffs characterize their lawsuit as exposing "a conspiracy by Defendants, each and every one of them, to reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin

." Am. Compl., prmbl. at 2 [Dkt. # 20]. They seek $120,000,000 in compensatory damages and $750,000,000 in punitive damages. Before the Court are three motions to dismiss, one for each set of defendants. Upon consideration of the pleadings, relevant law, and the entire record herein, the Court will GRANT the motions and DISMISS the amended complaint.

BACKGROUND

Plaintiffs Terry Aston, John Fratti, Linda Martin, David Melvin, and Jennifer Wilcox are five individuals who allege that they were injured by taking Levaquin

, a brand-name drug manufactured and sold by Johnson & Johnson. Am. Compl. ¶¶ 30–31, 78. Plaintiffs state that as result of their taking Levaquin, they suffered from "a constellation of medical issues" including "mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability," and have sustained damage "to the following body systems: neuromuscular, neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus[ ] endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory system; digestive system; genitourinary system; and connective tissue." Am. Compl. ¶ 78. Plaintiffs also say they have experienced

widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle wasting

, gait disturbances, severe balance issues, stiffness, spasms, joint pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing, slow digestive motility, abdominal pain, acid reflux, gastritis, nausea, constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss, glucose issues, respiratory issues, emotional issues, depression, psychosis, depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks, difficulty communicating, forgetfulness, bruising, vision issues, hearing issues, tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.

Am. Compl. ¶ 79. The amended complaint does not associate any of these symptoms with any individual plaintiff; nor does it allege when or why any individual plaintiff was prescribed Levaquin

, or when they began taking it. It does, however, assert that all five plaintiffs were left "unable to secure, maintain, and or perform the duties of employment" as a "direct result" of "the purchase and ingestion of Levaquin." Am. Compl. ¶ 80. Four of the five plaintiffs state that they have been unable to work since 2008 or earlier. Am. Compl. ¶¶ 82–85. The fifth plaintiff, David Melvin, states that he has been unable to work since 2012. Am. Compl. ¶ 81.

Plaintiffs further allege that Levaquin

is dangerous and that its label failed to adequately warn of these dangers when they took the drug. Levaquin contains the antibiotic levofloxacin. Am. Compl. ¶ 31. Levofloxacin is a fluoroquinolone, a class of broad-spectrum antibiotic drugs. Am. Compl. ¶¶ 31–32. Levaquin was approved by the FDA in 1996, Am. Compl. ¶ 31, went generic in 2011, Decl. of Lauren A. Moskowitz, Ex. C (FDA News Release) [Dkt. # 24–4], and has nine approved indications and uses: pneumonia ; acute bacterial sinusitis ; acute bacterial exacerbation of chronic bronchitis ; skin and skin structure infections; chronic bacterial prostatitis ; urinary tract infections ; acute pyelonephritis ; inhalational anthrax, post-exposure; and plague, Decl. of Jonah M. Knobler ("Knobler Decl."), Ex. 1 (2014 Levaquin Label) [Dkt. # 22–3].¹ The label for Levaquin warns of numerous potential side effects. These warnings—which were approved by the FDA, and which remain publically available on the FDA's website in current and historic form—were amended in 1998, 2000, 2004, 2007, 2008, 2011, 2013, and 2014. Id. , Exs. 1–8 [Dkts. # 22–3, # 22–4, # 22–5, # 22–6, # 22–7, # 22–8, # 22–9, # 22–10]. Because the amended complaint does not allege when any individual plaintiff took Levaquin, or what the label said at that time, it is impossible to tell precisely which warnings were in place at any relevant period. Nevertheless, the amended complaint alleges that plaintiffs were not adequately warned and that the label should have included additional warnings. Am. Compl. ¶¶ 34–38.²

Up to this point, the allegations in the amended complaint sound similar to those brought in a spate of products liability cases involving Levaquin

about a decade ago, which the Judicial Panel on Multi District Litigation centralized in the U.S. District Court for the District of Minnesota. See

In re Levaquin Prods. Liab. Litig. , 560 F.Supp.2d 1384 (J.P.M.L. 2008).³ From there, however, the amended complaint turns melodramatic. According to plaintiffs, the reason the labels on Levaquin were inadequate when they took the drug is because the defendants, "each and every one of them," were engaged in a "racketeering enterprise and conspiracy to fraudulently cover up and/or fail to disclose the true extent of the devastating, life-threatening, and deadly side effects of Levaquin

." Am. Compl. ¶ 33. The amended complaint accuses a full cast of characters of participating in this scheme. The principle role goes to defendant Dr. Margaret Hamburg, Commissioner of the FDA from 2009 to 2015. Am. Compl. ¶ 26. She is supported by her husband, defendant Peter Brown, who, along with defendant Robert Mercer, is Co–Chief Executive Officer of defendant Renaissance Technologies, LLC, a hedge fund that owned stock in defendant Johnson & Johnson, manufacturer of Levaquin. Am. Compl. ¶¶ 25–26, 30, 42, 52. Defendant James Simons, another Renaissance executive, was also allegedly involved. Am. Compl. ¶ 49. According to the amended complaint, Dr. Hamburg, "upon knowledge and agreement of all Defendants," "willfully covered up" and "suppressed" information about Levaquin. Am. Compl. ¶¶ 34, 96, 164. The key document Dr. Hamburg is said to have covered up is an April 2013 report from FDA scientists identifying a potential link between fluoroquinolones (such as levofloxacin ) and peripheral neuropathy caused by mitochondrial toxicity. Am. Compl. ¶¶ 34, 164. The alleged purpose of the cover up was to inflate the price of Johnson & Johnson stock and to obtain unspecified "gratuities and bribes" from the J & J defendants. Am. Compl. ¶¶ 96, 125. Amazingly, former presidents Barack Obama and Bill Clinton also make cameo appearances in plaintiffs' alleged scheme, together with former Secretary of State Hillary Clinton, and the Clinton Foundation; these actors are alleged to have solicited, or received, "gratuities" from defendants in exchange for securing Dr. Hamburg's appointment as FDA Commissioner. Am. Compl. ¶ 43–47.

Plaintiffs filed the instant action in January 2016. Their amended complaint alleges twenty-two counts. Counts One through Four allege that all defendants violated the federal Racketeer Influenced and Corrupt Organizations Act ("RICO"). Am. Compl. ¶¶ 139–71. Count Five alleges that all defendants violated Arizona's version of the RICO statute. Am. Compl. ¶¶ 172–78. Counts Six through Fourteen allege that the J & J defendants are liable under various common law theories sounding in tort and contract, and that the J & J defendants and the Renaissance defendants unjustly enriched themselves through the sale of Levaquin

. Am. Compl. ¶¶ 179–263. Count Fifteen alleges that the J & J defendants violated the Lanham Act. Am. Compl. ¶¶ 264–70. Counts Sixteen through Twenty–Two allege that the J & J defendants violated the consumer fraud statutes of the District of Columbia, New York, Maryland, Pennsylvania, Illinois, Arizona, and California. Am. Compl. ¶¶ 271–318.

On May 6, 2016, defendants each moved to dismiss the amended complaint. See J & J Defs.' Mot. to Dismiss the Am. Compl. [Dkt. # 22]; Def. Dr. Margaret A. Hamburg's Mot. to Dismiss the Am. Compl. [Dkt. # 23]; Mot. by the Renaissance Defs.' for Dismissal of the Am. Compl. [Dkt. # 24]. I held a motions hearing on July 28, 2016, after the motions were fully...