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Aston v. Johnson & Johnson

United States District Court, District of Columbia

March 30, 2017

TERRY ASTON, et al., Plaintiffs,
JOHNSON & JOHNSON, et al., Defendants.

          MEMORANDUM OPINION [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.


         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 briefed. On August 2, 2016, plaintiffs filed a notice clarifying and expanding some of their oral arguments. See Pis.' Supp. to Oral Arg. [Dkt. #45]. In addition, on July 13, 2016, plaintiffs' moved for leave to file a surreply, Pis.' Mot. for Leave to File Surreply [Dkt. #39], which I denied.


         Defendants move to dismiss the amended complaint for failure to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). "To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. The Court assumes a plaintiff s factual assertions to be true and draws all reasonable inferences his favor. See RSM Prod. Corp. v. Freshfields Bruckhaus Deringer U.S. LLP, 682 F.3d 1043, 1046 (D.C. Cir. 2012). The court need not, however, "accept inferences drawn by plaintiff if those inferences are not supported by the facts set out in the complaint." Hettinga v. United States, 611 F.3d 471, 476 (D.C. Cir. 2012) (per curiam) (citing Kowal v. MCI Commc'ns Corp., 16 F.3d 1271, 1276 (D.C. Cir. 1994)). Nor must the court "accept as true a legal conclusion couched as a factual allegation." Iqbal, 556 U.S. at 678.

         Several counts in the amended complaint allege claims for fraud or misrepresentation. Federal Rule of Civil Procedure 9(b) requires claims for fraud or misrepresentation to be pled "with particularity." To survive a motion to dismiss under this heightened standard, "the pleader [must] state the time, place and content of the false misrepresentations, the fact misrepresented and what was retained or given up as a consequence of the fraud." U.S. ex rel. Williams v. Martin-Baker Aircraft Co., 389 F.3d 1251, 1256 (D.C. Cir. 2004) (quoting Kowal, 16 F.3d at 1278). The pleader must also "identify individuals allegedly involved in the fraud." Id. (citing U.S. ex rel. Joseph v. Cannon, 642 F.2d 1373, 1385-86 (D.C. Cir. 1981)). These requirements "discourage the initiation of suits brought solely for their nuisance value and safeguard[] potential defendants from frivolous accusations of moral turpitude." Id. In addition, "because 'fraud' encompasses a wide variety of activities, the requirements of Rule 9(b) guarantee all defendants sufficient information to allow for preparation of a response." Id.


         1. Federal RICO Claims

         The centerpiece of the amended complaint is its four counts alleging that all defendants violated the federal Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. §§ 1961-1968, and seeking treble damages under the statute. Am. Compl. ¶¶ 139- 71. RICO "created four new criminal offenses involving the activities of organized criminal groups in relation to an enterprise." RJR Nabisco, Inc. v. European Cmty., 136 S.Ct. 2090, 2096 (2016) (citing 18 U.S.C. §§ 1962(a)-(d)). "RICO also created a new civil cause of action for' [a]ny person injured in his business or property by reason of a violation' of those prohibitions." Id. (quoting 18 U.S.C. § 1964(c)). RICO's civil cause of action has been read as conferring "standing, " Sedima, S.P.R.L. v. Imrex Co., 473 U.S. 479, 496 (1985), and as such, states "a jurisdictional requirement" that must be established by adequate pleading, Nat'l Org. for Women, Inc. v. Scheidler, 510 U.S. 249, 255 (1994).

         Defendants argue that plaintiffs' federal RICO claims are not cognizable because they are premised on harms flowing from injuries to plaintiffs' personal health. "The overwhelming weight of authority discussing the RICO standing issue holds that the 'business or property' language of Section 1964(c) does not encompass personal injuries, " Burnett v. Al Baraka Inv. & Dev. Corp., 214 F.Supp.2d 86, 101 (D.D.C. 2003) (collecting cases from the Second, Third, Fourth, Fifth, Sixth, Seventh, Eighth, Ninth, and Eleventh Circuits), and the Supreme Court, in construing identical statutory language in the Clayton Act-the statute "RICO's private right of action was modeled after, " RJR Nabisco, 136 S.Ct. at 2109-has explained that "[t]he phrase 'business or property'... exclude[s] personal injuries suffered, " Reiter v. Sonotone Corp.,442 U.S. 330, 339 (1979). Plaintiffs contend that their claims are not fairly characterized as seeking to redress personal injuries because their amended complaint alleges that their injuries resulted in "loss of earnings." Pis.' Mem. of Law in Support of Their Opp'n to the Renaissance Defs.' Mot. to Dismiss 23 (quoting Am. Compl. ¶ 156) ("Opp'n to Renaissance") [Dkt. #34]; see also Am. Compl. ¶¶ 81-85. But, as plaintiffs' counsel is well aware, courts in this District and elsewhere have consistently rejected the argument that pecuniary losses derivative of personal injuries are injuries to "business or property" cognizable under RICO. See, e.g., Klayman v. Obama,125 F.Supp.3d 67, 88 (D.D.C. 2015) (holding harm to Mr. Klayman's law practice did not confer RICO standing); Burnett, 274 F.Supp.2d at 102 (agreeing that "even pecuniary losses that are derivative of personal injuries are not 'business or property' injuries under RICO"); Jackson v. Sedgwick Claims Mgmt. Servs., Inc.,731 F.3d 556, 565-66 (6th Cir. 2013) (explaining "lost wages, rehabilitation services, and medical expenses" are "personal injuries [that] fail to confer relief under § 1964(c)"); Pilkington v. United Airlines,112F.3d 1532, 1536 (11th Cir. 1997) (finding "not cognizable under RICO" claim for ...

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