Aston v. Johnson & Johnson , 248 F. Supp. 3d 43 ( 2017 )

UNITED STATES DISTRlCT COURT
FOR THE DISTRICT OF COLUMBIA
TERRY AsToN, er 31., )
)
Plaintiffs, )
)
v. )
) Civil ease No. 16-0086 (RJL)
JoHNsoN & JoHNsoN, er al., )
) F I L E D
Defendams. ) MAR 3 1 2017
Cle|’k, U.S. Dl Ul t& B klll|)wy
MEMORANDUM oPINloN counswrme§»sinmi'i:ommma
(March ;U_, 2017) [Dkts. #22, #23, #24]
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 Grtho-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. #2()]. They seek $120,000,00() in compensatory damages and $750,00(),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. W 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. ll 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. il 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. lt 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. 1 80. Four
of the five plaintiffs state that they have been unable to work since 2008 or earlier. Am.
Compl. W 82-85. The fifth plaintiff, David Melvin, states that he has been unable to work
since 2012. Am. Compl. 11 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. 1l 31. Levofloxacin is a fluoroquinolone, a class of
broad-spectrum antibiotic drugs. Am. Compl. M 31-32. Levaquin was approved by the
FDA in 1996, Am. Compl. 11 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. l (2014 Levaquin Label) [Dkt. #22-3].' The label for
Levaquin warns of numerous potential side effects These warnings_which were
' l may take judicial notice of drug labels and other documents “publicly available on the FDA’s
website.” In re Avandia Mklg. Sales Practz`ces & Prods. Ll'ab, Litig., 588 F. App’x l7l, 174 n.l4 (3d Cir.
2014); see also Demissie v. Starbucks Corporate O]Yz`ce & Headquarters, 19 F. Supp. 3d 321, 324 (D.D.C.
2014) (“ln ruling on a motion to dismiss, the Court may consider . . . documents attached to a motion to
dismiss for which no party contests authenticity.”).
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 wamings. Am. Compl. 1111 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
2 As the J&J defendants point out and the labels show, Levaquin has included extensive warnings
since at least 1998. l\/lem. of Law in Supp. ofJ&J Defs.’ Mot. to Dismiss the Am. Compl. 2-4 (“J&J Mem.”)
[Dkt #22-1]; Decl. of Jonah M. Knobler (“Knobler Decl.”), Ex. 2 (l998 Levaquin Label) [Dkt. #22-3].
Potentia|ly relevant to some of the symptoms plaintiffs allege, the label has warned of peripheral neuropathy
since 2004, and has included “black box” warnings_the “strongest” warnings FDA can pr`ovide, PLIVA,
lnc. v. Mensing, 564 U.S. 604, 610 (2011)_-for tendinitis and tendon rupture since 2008, and for muscle
weakness since 2011. Knobler Decl., Exs. 4 (2004 Levaquin Label), 6 (2008 Levaquin Label), 7 (2011
Levaquin Label).
3 lndeed, it appears that one of the plaintiffs in this case, John Fratti, voluntarily withdrew from the
multi-district litigation. See Stip. of Voluntary Dismissal Without Prejudice, Fralti v. Johnson & Johnson,
No. 0:09-cv-00812-JRT (D. Minn.), ECF No. 17.
true extent of the devastating, life-threatening, and deadly side effects of Levaquin.” Am.
Compl. 11 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. 11 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. 1111 25-26, 30, 42,
52. Defendant J ames Simons, another Renaissance executive, was also allegedly involved.
Am. Compl. 11 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. 1111 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. 1111 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. 1111 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. 11 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 lnfluenced and Corrupt Organizations Act (“RICO”). Am. Compl. 1111 139-71.
Count Five alleges that all defendants violated Arizona’s version of the RICO statute. Am.
Compl. 1111 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. 1111 179~263. Count Fifteen alleges that the J&J defendants
violated the Lanham Act. Am. Compl. 1111 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.1111 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]. l 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 Pls.’ Supp. to Oral Arg. [Dkt. #45]. In addition, on July
13, 2016, plaintiffs’ moved for leave to file a surreply, Pls.’ Mot. for Leave to File Surreply
[Dkt. #39], which I denied.
STANDARD OF REVIEW
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 plaintiffs
factual assertions to be true and draws all reasonable inferences his favor. See RSM Prod.
Corp. v. Fresh/iela’s 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. Um`tea’ States, 677 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. Wi[ll`ams 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
7
“identify individuals allegedly involved in the fraud.” Ia’. (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.” Ia’. 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.” Ia’.
ANALYSIS
1. Federal RICO Claims
The centerpiece of the amended complaint is its four counts alleging that all
defendants violated the federal Racketeer lnfluenced and Corrupt Organizations Act, 18
U.S.C. §§ 1961~1968, and seeking treble damages under the statute. Am. Compl. 1111 139-
71. RICO “created four new criminal offenses involving the activities of organized
criminal groups in relation to an enterprise.” RJR Nabl`sco, Inc. v. Europecm ley., 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.” Ia'. (quoting 18 U.S.C. § 1964(0)). RICO’s civil cause of action has
been read as conferring “standing,” Sedima, S.P.R.L. v. lmrex 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 (l994).
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 RICC) standing issue holds that the
8
‘business or property’ language of Section 1964(c) does not encompass personal injuries,”
Burnelt v. AIBara/ca Inv. & Dev. Corp., 274 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 Nabl`sco, 136 S.
Ct. at 2109_has explained that “[t]he phrase ‘business or property’ . . .exclude[s] personal
injuries suffered,” Rel`ter 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 eamings.” Pls.’
Mem. of Law in Support of Their Opp’n to the Renaissance Defs.’ Mot. to Dismiss 23
(quoting Am. Compl. 11 156) (“Opp’n to Renaissance”) [Dkt. #34]; see also Am. Compl.
1111 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. Sea’gwick 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(0)”); Pilkington v. Um`tea’
Airlines, 112 F.3d 1532, 1536 (l lth Cir. 1997) (finding “not cognizable under RICO” claim
for “pecuniary losses resulting from personal injury”); Bast v. Cohen, Dunn & Sinclal'r,
9
PC, 59 F.3d 492, 495 (4th Cir. 1995) (“[P]ersonal injury and pecuniary losses occurring
therefrom are not sufficient to meet the statutory requirement of injury to ‘business or
property.”’). I find these decisions persuasive, and hold, consistent with the weight of
authority, that plaintiffs have failed to plead injuries cognizable under RIC().4
Before moving on, I will address plaintiffs’ argument that they have RICO standing
under our Circuit’s tobacco litigation precedents Opp’n to Renaissance 1-2, 19-23.
Specifically, plaintiffs contend that I must allow their case to go forward because the
personal health injuries they allege are similar to the personal health injuries alleged in
Um'tea' States v. Phl`ll`p Morrz's USA, Inc., 449 F. Supp. 2d l (D.D.C. 2006), aj§”a’ in part,
vacated in part, 566 F.3d 1095 (D.C. Cir. 2009). Whatever similarities may exist between
this case and that one, plaintiffs ignore a critical distinction th`lip Morris was brought by
the U.S. Department of Justice under a separate statutory provision, 18 U.S.C. § 1964(b),
which, unlike the private right of action created by 18 U.S.C. § 1964(c), does not require a
showing of injury to business or property. Compare Philz'p Morris, 566 F.3d at 1145
(explaining “Section 1964(b) authorizes the Attorney General to institute proceedings . . .
for equitable remedies” (internal quotations and citation omitted)) with Serv. Employees
Int’l Unl`on Health & Welfare Furzd v. Philip Morris Inc., 249 F.3d 1068, 1076 (D.C. Cir.
2001) (acknowledging, in dictum, that “individual smokers” could “perhaps” bring civil
4 Plaintiffs urge me to reject the majority position in favor of the more expansive view of “business
or property” taken by the Ninth Circuit in Diaz v. Gates, 420 F.3d 897 (9th Cir. 2005) (en banc) (per
curiam). l reject this invitation. Diaz has received significantjudicial criticism, see id. at 907 (Gould, J.,
dissenting); Evans v. Cizy of Chicago, 434 F.3d 916, 931 n. 26 (7th Cir. 2006), overruled on other grounds
by Hill v, Tangherlini, 724 F.3d 965 (7th Cir. 2013); Bougopoulos v. Altria Grp,, lnc., 954 F. Supp. 2d 54,
66 (D.N.H. 2013), and l find its reasoning unpersuasive
1()
RICO claims under § 1964(c) “to the extent they can prove a measure of damages distinct
from personal injuries”). Indeed, the remedies provided by § 1964(b) and § 1964(c) are so
distinct that “the United States government does not have standing to sue for damages to
its business or property” under § l964(b). United States v. Bonanno Organizea’ Crime
Famz'ly ofLa Cosa Nostra, 683 F. Supp. 1411, 1456 (E.D.N.Y. 1988), ajjf’a’, 879 F.2d 20
(2d Cir. 1989). th'lz'p Morrz`s is simply not relevant to determining whether plaintiffs have
adequately pled injuries to their business or property as required by the statute.
Even if plaintiffs’ personal injuries were cognizable under RICO, I would have to
dismiss their claims because plaintiffs have not plausibly alleged that they were injured
“by reason of" a RICO violation. 18 U.S.C. § 1964(c). In addition to requiring a plaintiff
to plead an injury to his business or property, RlCO’s cause of action requires a plaintiff to
plead that this injury was proximately caused by the defendant’s RICO violation. See
Lexmark 1th ’l, ]nc. v. Stath Control Components, Inc., 134 S. Ct. 1377, 1386-87 (2014)
(citing Holmes v. Sec. Investor Prot. Corp., 503 U.S. 258, 265~68 (l992)); ia’. at 1391 n.6
(citing Iqbal, 556 U.S. at 678-79). Here, the lynchpin of plaintiffs’ RICO theory is that
Dr. Hamburg “willfully covered up” the FDA’s April 2013 report linking Levaquin to
mitochondrial toxicity as part of defendants’ alleged conspiracy to inflate J&J’s stock price.
Am. Compl. 11 34; see also Tr. of Mot. Hr’g 40-41 [Dkt. #46]; Pls.’ Supp. to Oral Arg. 2~
3. According to plaintiffs, the “causal chain” linking the alleged cover up to their injuries
“is extremely direct and simple. Defendants engaged in a conspiracy to willfully suppress
the deadly effects of Levaquin to Plaintiffs, physicians, and the public at large, and as a
direct result, Plaintiffs consumed Levaquin and were seriously injured.” Pls.’ Mem. of
11
Law in Opp’n to J&J Defs.’ Mot. to Dismiss 15 (“Opp’n to J&J”) [Dkt. #32]. But there is
a major kink in this chain. The amended complaint states that David Melvin, the last of
the five plaintiffs to be injured by Levaquin, “became unable to work on or around 2012.”
Am. Compl. 11 81. That is the year prior to the alleged suppression of the FDA report.
Barring some sort of temporal paradox, see H.G. Wells, The Tz'me Machine 22~23 (1895),
there is no way that suppression of an FDA report in 2013 could have caused plaintiffs to
be injured in 2012 or earlier. Because plaintiffs’ “allegations, taken as true, are insufficient
to establish proximate causation,” their federal RICO counts “must be dismissed.”
Lexmark, 134 S. Ct. at 1391 n.6.5
2. Arizona RICO Claims
Plaintiffs also allege violations by all defendants of Arizona’s civil racketeering
statute, Ariz. Rev. Stat. § 13-2314.04. Am. Compl. 1111 172-78. “Arizona’s RICO act is
patterned after the federal RICO act.” Rosier v. Fz'rst Firz. Capital Corp., 889 P.2d 11, 13-
14 (Ariz. Ct. App. 1994). “[T]o state a cause of action for civil damages under [Arizona’s]
RICO, the plaintiffs damages must be proximately caused by the defendant’s violation of
a predicate RICO act.” Id. at 15; see also First United Fundirzg, LLC v. Four Corners Dev.,
LLC, No. 1 CA-CV 15-0377, 2016 WL 6080599, at *4 (Ariz. Ct. App. Oct. 18, 2016)
(unpublished) (affirming dismissal). As discussed above, plaintiffs have failed to plead
5 ln light of my conclusion that plaintiffs have not adequately pled standing or causation as required
by § 1964(c), it is unnecessary for me to reach defendants’ arguments that plaintiffs have not pled facts
sufficient to allege substantive violations of §§ 1962(a)-(d). See Mem. of Law in Supp. of the Renaissance
Defs.’ Mot. to Dismiss the Am. Compl. 19~37 (“Renaissance Mem.”) [Dkt. #24-7]; J&J Mem. 16-20. For
the same reason, l need not reach Dr. Hamburg’s argument that she is protected from suit by the doctrine
of qualified immunity. See Mem. of Law in Supp. of Dr. Margaret A. Hamburg’s Mot. to Dismiss the Am.
Compl. 15-24 [Dkt. #23-1].
12
facts that make possible_let alone plausible_the conclusion that the alleged cover up by
defendants was the proximate cause of plaintiffs’ injuries Thus, assuming arguendo that
plaintiffs as a group have a sufficient connection with Arizona to invoke her RICO
statute_an issue defendants contest-their claims fail for the same reason as under the
federal statute.
3. Lanham Act Claims
Plaintiffs allege that the J&J defendants violated the Lanham Act, 15 U.S.C.
§ 1125(a), by making “false and/or misleading statements” concerning Levaquin that
“deceived and/or had the capacity to deceive consumers.” Am. Compl. 11 267. The
Supreme Court has held that “to come within the zone of interests in a suit for false
advertising under § 1125(a), a plaintiff must allege an injury to a commercial interest in
reputation or sales.” Lexmark, 134 S. Ct. at 1390 (emphasis added). Consumer claims are
therefore not cognizable “A consumer who is hoodwinked into purchasing a disappointing
product may well have an injury-in-fact cognizable under Article III, but he cannot invoke
the protection of the Lanham Act[.]” Ia’. In light of this clear and binding authority, 1
decline plaintiffs’ invitation to engage in a wholesale reconstruction of the statute, see
Opp’n to J&J 34, and will dismiss their Lanham Act claim.
4. Common Law Claims
Plaintiffs, who reside in Maryland, Pennsylvania, Arizona, lllinois, and Califomia,
assert nine common law claims sounding in tort and contract law against Johnson &
Johnson, a citizen of New Jersey. One of these claims, for unjust enrichment, is also
asserted against Renaissance, a company organized under the laws of Delaware and with
13
its principle place of business in New York. Although plaintiffs did not bring these claims
under the law of any particular jurisdiction, they now contend that the common law of the
District of Columbia applies, or in the alternative, the common law of the States where
each individual plaintiff resides Opp’n to J&J 16_17. Defendants are willing to concede,
for purpose of analysis, that District of Columbia law applies J&J Mem. 23; Renaissance
Mem. 40 n.9.6 In light of the parties’ stance, and given the paucity of factual allegations
in the amended complaint that would be necessary to a proper choice of law analysis, I will
apply D.C. law to plaintiffs’ common law claims in deciding the motions to dismiss See
In re APA Assessmertt Fee Litig., 766 F.3d 39, 45~46 (D.C. Cir. 2014).
a. Products Liability
Three counts in the amended complaint allege that Levaquin was “defective” and
assert that the J&J defendants are strictly liable and liable for negligence Am. Compl.
1111 186-202, 255_63. ln the District of Columbia, a product may be found defective “if it
has one of three shortcomings: (l) a manufacturing defect; (2) an absence of sufficient
warnings or instructions; or (3) an unsafe design.” Warner FruehaufTrailer Co. v. Boston,
654 A.2d 1272, 1274 (D.C. 1995 ); accord Restatement (Third) of Torts: Products Liability
§ 2 (1998) (“A product is defective when, at the time of sale or distribution, it contains a
6 The J&J defendants suggest, but appear unwilling to commit to, the position that under a choice of
law analysis New Jersey law would govern the claims brought against them. See J&J Mem. 24 (“Assuming
arguendo, that New Jersey law governs . . . .”). Under New Jersey law, nearly all of plaintiffs’ common
law claims would presumably be subsumed -by the New Jersey Products Liability Act, which
“encompass[es] virtually all possible causes of action relating to harms caused by consumer and other
products” In re Lead Painl Litig., 924 A.2d 484, 503 (N.J. 2007). I will not decide whether New Jersey
law applies, however7 because the J&J defendants “do not ask.” Fislzer v. Univ. of T exas atAustin, 133 S.
Ct. 2411, 2419 (2013); see id. at 2422 (Scalia, J., concurring).
14
manufacturing defect, is defective in design, or is defective because of inadequate
instructions or warnings.”). The amended complaint fails to state a plausible claim under
any recognized products liability theory.
To begin with, the allegations of manufacturing defect in the amended complaint
are nothing more than conclusory statements Plaintiffs insert some form of the word
“manufacture” into numerous lists throughout the amended complaint which purport to
describe the actions of the J&J defendants, including, among other things, that the J&J
defendants “manufacture,” “manufactured,” or are the “manufacturer” of, Levaquin. E.g.,
Am. Compl.1111 12, 17, 22, 30, 123, 187~88, 195, 204, 256-57. But for all these recitals of
the term “manufacture” and its derivatives, plaintiffs plead no facts “that would appear to
relate to manufacturing defects in the [Levaquin] doses taken by [plaintiffs].” Rolliris v.
Wackenhut Servs., 802 F. Supp. 2d 111, 122 (D.D.C. 2011) (emphasis added) (dismissing
claim against drug manufacturer under D.C. law), a/j”’d, 703 F.3d 122 (D.C. Cir. 2012).
Plaintiffs never allege, for example, that the doses of Levaquin they took deviated from
other doses manufactured by J&J, or from their FDA-approved design. The pleading is
thus plainly inadequate to support a claim for manufacturing defect.
l must also reject as inadequately pled plaintiffs’ allegations that the J&J defendants
failed to warn sufficiently of “the hidden, dangerous risk posed by Levaquin.” Am. Compl.
1111 196, 197. To state a failure to warn claim with plausibility, the plaintiff must plead facts
“affording a reasonable basis for the belief that appellants’ failure to provide adequate
warnings was a substantial factor in bringing about the harm at issue.” E. Perm Mfg. Co.
v. Pinea’a, 578 A.2d 1113, 1124 (D.C. 1990) (emphasis deleted); accord Restatement
15
(Third) of Torts: Product Liability § 15, cmt. a (l998) (restating “[r]equirement of causal
connection between defect and harm”). The amended complaint here does not allege any
facts that, when taken as true, support a plausible inference that Levaquin’s warning labels
were a substantial factor in causing plaintiffs’ injuries See Iqbal, 556 U.S. at 678.
“Nowhere,” for example, “does the complaint recite the contents of the warning label . . .
at the time of the administration of the drug” or explain “how the contents of the label were
inadequate.” Bailey v. Janssen Pharmaceutica, Inc., 288 F. App’x 597, 609 & n.13 (1 lth
Cir. 2008) (affirming dismissal of failure to warn claim). Nor does it plead “facts about
the timing of [each plaintiff s] use of [Levaquin], the onset of [their injuries], or how the
alleged distinctions in the warnings would have had a causal effect.” Salvio v. Amgen, Inc. ,
810 F. Supp. 2d 745, 752 (W.D. Pa. 2011) (dismissing failure to warn claim); see also
Rollins, 802 F. Supp. 2d at 123_24 & n.8. Indeed, the amended complaint is entirely vague
as to when each individual plaintiff was prescribed Levaquin, what injuries each individual
plaintiff experienced, and why they think Levaquin was the cause of these injuries_let
alone why they think inadequate warnings contributed to their injuries To be sure, as
plaintiffs point out, the amended complaint does assert that if the J&J defendants had “used
an alternative warning which fully disclosed the hidden deadly risks posed by Levaquin,
Plaintiffs would not have ingested Levaquin and Plaintiffs[’] physicians on information
and belief, would not have prescribed Levaquin to Plaintiffs.” See Opp’n to J&J 21 nn.29~
30 (citing Am. Compl. 11 197); see also Am. Compl. 1111 91-92, 198. But without factual
allegations supporting this claim, it is nothing more than “a legal conclusion couched as a
16
factual allegation.” lqbal, 556 U.S. at 678. As such, it is insufficient to state a claim for
product defect based upon failure to warn.
Nor can plaintiffs state a claim for design defect. In Mutual Pharmaceutical Co. v.
Bartlett, 133 S. Ct. 2466, 2479 (2013), the Supreme Court held “that state-law design-
defect claims . . . that place a duty on [pharmaceutical] manufacturers to render a drug safer
by either altering its composition or altering its labeling are in conflict with federal laws
that prohibit manufacturers from unilaterally altering drug composition or labeling” and
are therefore preempted The amended complaint expressly pleads that the J&J defendants
should have used “other designs.” Am. Compl. 1111 199, 260. Nevertheless, plaintiffs
contend that Mutual Pharmaceutical does not control because its conflict preemption
reasoning applies only to “generic drugs and not ‘brand name’ drugs” like Levaquin.
Opp’n to J&J 19. Plaintiffs are mistaken. Mutual Pharmaceutical expressly found that
“[o]nce a drug-whether generic or brand-name_-is approved, the manufacturer is
prohibited from making any major changes to [its formulation]” by federal law. 133 S. Ct.
at 2471. Thus, even though Mutual Pharmaceutical arose from a state-law design-defect
claim against a manufacturer of a generic drug, its holding applies to both types of drugs,
and plaintiffs’ design-defect claim must be dismissed7
7 This result is not, as plaintiffs claim, “bizarre” or “nonsensical.” Opp’n to J&J 19~20. lt is in fact
fully consistent with the well-established tort law principle, “especially common in the field of drugs,” that
an unavoidably unsafe product is “not defective, nor is it unreasonably dangerous” where it is “properly
prepared, and accompanied by proper directions and warning.” Restatement (Second) of Torts § 402A,
cmt. k (1965); see also Rollins 703 F.3d at 130 n.2.
17
b. Fraud and Misrepresentation
Plaintiffs also assert three common law fraud and misrepresentation theories Am.
Compl. 1111 203-20, 234_54. As noted at the outset, Federal Rule of Civil Procedure 9(b)
requires such claims to “state the time, place and content of the false misrepresentations”
and to “identify individuals allegedly involved in the fraud.” Martin-Baker, 389 F.3d at
1256. The amended complaint fails to comply with these requirements
To begin with, plaintiffs fail to state with particularity the “time” of the alleged
fraud. Id. The amended complaint states that defendants have “made misrepresentations”
about Levaquin’s safety “[s]ince at least 1996.” Am. Compl. 11 236; see also Opp’n to J&J
24 (relying on this allegation). However, that allegation spans the more than twenty-year
period that Levaquin has been on the market, and therefore is insufficient “to allow for
preparation of a response” by defendants Martin-Baker, 389 F.3d at 1256; accord U.S. ex
rel. Gage v. Davis S.R. Aviation, L.L.C., 623 F. App’x 622, 627 (5th Cir. 2015) (finding
allegations that defendant engaged in fraudulent activity “between 2009 and 2011 . . . not
specific enough to comply with Rule 9(b)”). Nor does the amended complaint adequately
allege the “place” of the fraud. Martin-Baker, 389 F.3d at 1256. Plaintiffs have not
alleged, for example, “whether each individual Plaintiffs [encountered the
misrepresentations] and purchased [Levaquin] in their state of residence.” Mouzon v.
Radiancy, Inc., 85 F. Supp. 3d 361, 381 (D.D.C. 2015) (dismissing action).
“The complaint also fails to identify with specificity who precisely was involved in
the fraudulent activity.” Martin-Baker, 389 F.3d at 1257. Plaintiffs’ allegations of
common law fraud and misrepresentation are directed at three corporate entities-Johnson
18
& Johnson, Johnson & Johnson Pharmaceutical Research & Development, and Ortho-
McNeil-Janssen Pharmaceuticals. Am. Compl. 1111 203, 234, 247. Not only do plaintiffs
fail to “identify individuals” associated with these companies Martin-Baker, 389 F.3d at
1257, they do not even specify which corporate entity they believe was responsible, cf
Anderson v. USAA Cas. Ins. Co., 221 F.R.D. 250, 255 (D.D.C. 2004) (dismissing negligent
misrepresentation claim for “advancing nothing more than what appears to be a blanket
belief that the defendants as a group ‘misrepresented or withheld material and significant
facts”’). ln sum, plaintiffs fall woefully short of pleading any specific allegations that
would support a claim of fraud or misrepresentation
c. Breach of Express or Implied Warranties
Plaintiffs also assert claims against the J&J defendants for breach of express and
implied warranties Am. Compl. 1111 221~33. Plaintiffs’ claim for breach of express
warranty must be dismissed because “Plaintiff[s] ha[ve] not adequately pleaded any
express promises made by Defendant[s]” as required by D.C. law. Witherspoon v. Philip
Morris Inc., 964 F. Supp. 455, 465 (D.D.C. 1997) (dismissing claim). To be sure, the
amended complaint asserts that “Defendants expressly warranted that Levaquin was safe”
and that “Plaintiffs either directly or indirectly through Plaintiffs’ prescribing physicians
did in fact see and hear these representations and justifiably relied on these
representations” Am. Compl. 1111 222~23. But these allegations are insufficient without
more factual content supporting them. Courts in other jurisdictions have found that to state
a claim for breach of express warranty in cases involving prescription drugs, “Plaintiff[s]
must allege facts demonstrating that Defendants’ affirmations formed the basis of the
19
bargain, i.e., facts regarding how the warranties were made to Plaintiffs physician, and
that Plaintiff’s specific physician relied on them.” Hammarlund v. C.R. Bard, Inc., No.
215CV05506SVWJEM, 2015 WL 5826780, at *5 (C.D. Cal. Oct. 2, 2015); see also
Rarnirez v. Medtronic Inc., 961 F. Supp. 2d 977, 1001 (D. Ariz. 2013) (similar). l find
these decisions persuasive, and plaintiffs’ failure to move beyond labels and conclusions
by providing specific allegations is fatal to their express warranty claim.
As for plaintiffs’ breach of implied warranty claim, little analysis is necessary.
Defendants argue that this claim is duplicative, and in any event, cannot be independently
maintained in a case involving prescription drugs J&J Mem. 33_34. Plaintiffs do not
contest these arguments and therefore have conceded them. See Baggs v. Powell, 293 F.
Supp. 2d 135, 141 (D.D.C. 2003) (arguments not addressed in an opposition may be treated
as conceded) (citing FDIC v. Bender, 127 F.3d 58, 67~68 (D.C. Cir. 1997)).
d. Unjust Enrichment
Rounding out their common law claims plaintiffs allege that the J&J defendants
and the Renaissance defendants have unjustly enriched themselves through the sale of
Levaquin Am. Compl. 1111 179-85. All parties agree that “[u]njust enrichment occurs
when: (1) the plaintiff conferred a benefit on the defendant; (2) the defendant retains the
benefit; and (3) under the circumstances the defendant’s retention of the benefit is unjust.”
Bregman v. Perles, 747 F.3d 873, 876 (D.C. Cir. 2014); see Renaissance Mem. 39-40;
Opp’n to Renaissance 39; J&J Mem. 36; Opp’n to J&J 26. Both sets of defendants contend,
for different reasons that this claim should be dismissed because the amended complaint
20
does not, in their view, allege enough facts for me to draw the reasonable inference that
any benefit was conferred on them by plaintiffs8
The Renaissance defendants have the easier argument to make in this regard.
According to plaintiffs the Renaissance defendants received a benefit because, as minority
stockholders in publically traded Johnson & Johnson, they must have “earned profits” from
the sale of Levaquin to plaintiffs Opp’n to Renaissance 39. However, any such earnings
are far too remote and speculative to support an unjust enrichment claim. Cf Prime Mover
Capital Partners L.P. v. Elixir Gaming Techs., Inc., 898 F. Supp. 2d 673, 697 (S.D.N.Y.
2012) (dismissing claim because the “indirect benefit from [plaintiffs’] stock purchases”
was “insufficient to sustain an unjust enrichment claim”), aff’d, 548 F. App’x 16 (2d Cir.
2013). As such, l have no trouble dismissing this count against the Renaissance defendants
Plaintiffs’ theory is less attenuated in regard to the J&J defendants obviously, the
manufacturer of a product obtains some benefit when its product is sold or resold to
consumers lt remains a bridge too far, however, because plaintiffs have not pled that they
conferred a benefit on the J&J defendants As the J&J defendants correctly point out, the
amended complaint does not allege “that Plaintiffs paid any money for Levaquin, rather
than relying on an insurer, as most patients do.” J&J Mem. 36. This omission is significant
because there is “no authority demonstrating that benefits received from third-parties can
8 ln addition, the J&J defendants assert that 1 should dismiss plaintiffs’ claim because plaintiffs have
pled various other legal theories and unjust enrichment is a common law equitable claim available only
where there is no adequate remedy at law. J&J Mem. 35 . This argument misapprehends Rule 8, which
expressly permits pleading in the alternative. Fed. R. Civ. P. 8(d)(2); see also 1-2 James Wm. Moore et al.,
Moore ’s F ederal Practice § 2.03 (Matthew Bender 3d ed.) (“It is not generally a ground for dismissal of a
complaint asserting equitable claims that the plaintiff has an adequate remedy at law.”).
21
be the proper subject of an unjust enrichment claim.” Council on Am.-lslamic Relations
Action Network, ]nc. v. Gaubatz, 82 F. Supp. 3d 344, 358~59 (D.D.C. 2015) (granting
summary judgment for defendant where “Plaintiffs have identified only benefits that
Defendants have received from third parties”); see also Sabre Int ’l Sec. v. Torres Advanced
Enter. Solsi, LLC, 60 F. Supp. 3d 36, 41-42 (D.D.C. 2014) (dismissing claim where
plaintiff failed to allege that “it conferred any benefit on the Individual Defendants
directly”); Snyder v. Farnam Companies, lnc., 792 F. Supp. 2d 712, 724 (D.N.J. 2011)
(“When consumers purchase a product from a third party, they confer a benefit on that third
party, not on the manufacturer.”). Plaintiffs’ only response when confronted with this
pleading defect is to argue that 1 should blind myself to the common sense reality of how
prescription drugs are ordinarily purchased at risk of “improperly insert[ing] facts and
presumptions contrary to the standard set forth in Iqbal.” Opp’n to J&J 27. Plaintiffs are
mistaken labal teaches that “[d]etermining whether a complaint states a plausible claim
for relief" is “a context-specific task that requires the reviewing court to draw on its judicial
experience and common sense.” 556 U.S. at 679 (emphasis added). Where, as here, “the
well-pleaded facts do not permit the court to infer more than the mere possibility of
misconduct, the complaint has alleged-but it has not ‘show[n]’_‘that the pleader is
entitled to relief.”’ Id. (quoting Fed. Rule Civ. Proc. 8(a)(2)). Because plaintiffs have not
pleaded any facts showing that they paid for Levaquin, 1 must dismiss their unjust
enrichment claim against the J&J defendants
22
4. State Consumer Fraud Claims
The amended complaint also asserts seven state law consumer fraud claims against
the J&J defendants under the statutes of D.C., New York, Maryland, Pennsylvania, Illinois,
Arizona, and Califomia, Am. Compl. 1111 271~318. Each count fails to state a claim.
First, courts construing the consumer fraud statutes of six of these seven
jurisdictions have held that the statutes do not apply to the types of claims plaintiffs assert
here. These courts have held either that the statutes do not apply to personal injury claims
see Arndt v. Johnson & Johnson, 67 F. Supp. 3d 673, 682 (E.D. Pa. 2014) (“[P]ersonal
injury claims are not permitted under the Pennsylvania statute[.]”); Harshbarger v. Philip
Morris, lnc., No. 02-05267, 2003 WL 23342396, at *6 (N.D. Cal. Apr. 1, 2003) (“Personal
injuries . . . are not compensable under [the California B & P Code].”), or more commonly,
that they do not apply to claims involving prescription drugs see Pease v. Al)bott Labs.,
Inc., No. ClV. 12-1844, 2013 WL 174478, at *2 (D. Md. Jan. 16, 2013) (“[P]rescription
drugs are not ‘consumer goods’ under the [Maryland Consumer Protection Act].”); Kester
v. Zimmer Holdings, lnc., No. 210-CV-00523, 2010 WL 2696467, at *14 (W.D. Pa. June
16, 2010) (“[A] plaintiff does not have a viable [Pennsylvania Unfair Trade Practices and
Consumer Protection Law] cause of action against a manufacturer of prescription drugs.”);
Amos v. Biogen Idec Inc., 28 F. Supp. 3d 164, 173 (W.D.N.Y. 2014) (“[A]ny alleged
deceptive act related to the issuance of those [drug] warnings is not a ‘consumer oriented’
act actionable under Section 349 of the New York General Business Law.”); Barkley v.
D.C. Water & SewerAuth., 2013 CA 003811 B, 2016 D.C. Super. LEXIS 1, at *30 (D.C.
Super. Ct. 2016) (recognizing the D.C. Consumer Protection Procedures Act does “not
23
grant individuals a private right to sue for ‘damages for personal injury of a tortious
nature”’); Bober v. Glaxo Wellcome PLC, 246 F.3d 934, 942 (7th Cir. 2001) (holding
lllinois Consumer Fraud Act exempts “highly regulated” pharmaceutical companies from
liability). Arizona is the lone exception See Watts v. Medicis Pharm, Corp., 365 P.3d
944, 953 (Ariz. 2016) (“[T]he [Arizona Consumer Fraud Act] applies to prescription
pharmaceuticals”).9
Second, plaintiffs have not adequately pled their claims under the consumer fraud
statutes of any of these States including Arizona’s. As discussed above, claims based on
fraud must be pled “with particularity.” Fed. R. Civ. P. 9(b); see also Mouzon, 85 F. Supp.
3d at 378-79 (applying Rule 9(b) to consumer fraud claims brought under Califomia, D.C.,
lllinois, Maryland, and Pennsylvania Statutes). Plaintiffs contend that they have satisfied
this heightened pleading standard in regard to their statutory claims because the amended
complaint alleges that “Defendants made false and/or misleading statements of fact in
commercial advertisements productions and reports about Levaquin,” and that
“Defendants advertised and represented Levaquin without providing warning of the risks
and dangers of ingesting Levaquin.” Opp’n to J&J 29-30 (quoting Am. Compl. 1111 272,
277, 278). But these conclusory statements are not enough for me to avoid finding that
9 ln addition, plaintiffs’ claims under the D.C. and New York statutes must be dismissed because
neither statute applies extraterritorially and the amended complaint does not allege that any of the plaintiffs
reside in, were prescribed Levaquin in, consumed Levaquin in, or suffered injury in, either jurisdiction See
Shaw v. Marriott Int’l, Inc., 605 F.3d 1039, 1045 (D.C. Cir. 2010) (holding plaintiff“cannot state a claim
under the [D.C. Consumer Protection Procedures Act]” where he “is not a citizen of the District” and the
defendant “is [not] a business entity located in the District”); Goshen v. Mut. Life Ins. Co. of N.Y., 774
N.E.Zd 1190 (N.Y. 2002) (“[T]o qualify as a prohibited act under [General Business Law § 349], the
deception ofa consumer must occur in New York.”).
24
“Plaintiffs have not alleged the basic circumstances under which they were exposed to the
[misrepresentations] and purchased [Levaquin], which the Court would expect the
individual Plaintiffs to recall.” Mouzon, 85 F. Supp. 3d at 381. As 1 stated above in regard
to plaintiffs’ common law fraud claims the “missing basic facts include whether each
individual Plaintiff [encountered the misrepresentations] and purchased [Levaquin] in their
state of residence.” Id. In addition, because plaintiffs suggest in each statutory count that
they relied upon their doctors’ decisions to prescribe Levaquin, Am. Compl. 1111 273-74,
279-80, 285-86, 292-93, 299-300, 306-017, 316-17, the circumstances of those
prescription decisions and plaintiffs’ reliance on them, are particularly important_yet
plaintiffs allege no information about them. “[T]he absence of detail about Plaintiffs
experiences leads to the conclusion that Plaintiffs have not pleaded these claims with the
requisite particularity.” Mouzon, 85 F. Supp. 3d at 381; see also Jejj”erson v. Collins, 905
F. Supp. 2d 269, 290 (D.D.C. 2012) (dismissing claim where “the amended complaint
offers no details concerning when and where this [fraudulent] statement was made, who
made it, and what the plaintiffs gave up or retained as a consequence of it”).
CONCLUSION
The medical symptoms and conditions experienced by plaintiffs Terry Aston, John
Fratti, Linda Martin, David Melvin, and Jennifer Wilcox are “tragic and evoke[] deep
sympathy.” Mutual Pharm., 133 S. Ct. at 2480. Nevertheless, the decision to let their case
go forward or to dismiss it at the pleading stage “ultimately depends not on [their]
condition, but on [their] complaint.” McElroy v. Amylin Pharm., Inc., 573 F. App’x 545,
546 (6th Cir. 2014). Because the amended complaint “pleads facts that are merely
25
consistent with defendant[s’] liability, it stops short of the line between possibility and
plausibility of entitlement to relief.” Iqbal, 556 U.S. at 678 (quotation marks omitted).
Accordingly, the Court will GRANT the motions and DISMISS the amended complaint.
An Order consistent with this decision accompanies this Memorandum Opinion.
RICHARD ON
United States District Judge
26