Aston v. Johnson & Johnson

248 F. Supp. 3d 43, 2017 U.S. Dist. LEXIS 49229
CourtDistrict Court, District of Columbia
DecidedMarch 31, 2017
DocketCivil Action No. 2016-0086
StatusPublished
Cited by10 cases

This text of 248 F. Supp. 3d 43 (Aston v. Johnson & Johnson) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Aston v. Johnson & Johnson, 248 F. Supp. 3d 43, 2017 U.S. Dist. LEXIS 49229 (D.D.C. 2017).

Opinion

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 (collec *46 tively, “plaintiffs”), bring this twenty-two count action against three sets of defendants: Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, LLC, and Ortho-McNeil-Jans-sen 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 Leváquin, 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, neuropsychia-tric adverse évents, and multi-system disability,” and have sustained damage “to the following body systems: neuromuscu-lar, neuropsychiatric, peripheral neuropa-thy, 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 damagé, 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 Leva-quin.” Am.. Compl. ¶ 80. Four of the five plaintiffs, state that they have been unable *47 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 Leva-quin 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, Deck 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, Deck of Jonah M. Knobler (“Knobler Deck”), Ex. 1 (2014 Le-vaquin 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 publieally 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-threat *48 ening, and deadly side effects of Leva-quin.” 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 eovéred up” and “suppressed” information about Levaquin. Am. Compl. ¶¶ 34, 96, 164. The key document Dr.

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248 F. Supp. 3d 43, 2017 U.S. Dist. LEXIS 49229, Counsel Stack Legal Research, https://law.counselstack.com/opinion/aston-v-johnson-johnson-dcd-2017.