United States District Court, District of Columbia
MEMORANDUM OPINION [DKTS. #22, #23, #24]
RICHARD J. LEON United States District Judge
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.
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.
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]. 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.
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). 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.
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.
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.
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.
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.
Federal RICO Claims
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).
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 ...