Teamsters Local 237 Welfare Fund v. AstraZeneca Pharmaceuticals LP

IN THE SUPREME COURT OF THE STATE OF DELAWARE
TEAMSTERS LOCAL 237 WELFARE §
FUND; LOCAL 237 TEAMSTERS §
RETIREES’ BENEFIT FUND; LOCAL §
237 TEAMSTERS-PLAINVIEW-OLD §
BETHPAGE CENTRAL SCHOOL §
DISTRICT HEALTH AND WELFARE §
TRUST FUND; LOCAL 237 §
TEAMSTERS-NORTH BABYLON §
SCHOOL DISTRICT HEALTH AND §
WELFARE TRUST FUND; LOCAL §
237 TEAMSTERS-BRENTWOOD §
SCHOOL DISTRICT HEALTH AND §
WELFARETRUST FUND; AND § No. 415, 2015
LOCAL 237 TEAMSTERS-SUFFOLK §
REGIONAL OFF-TRACK BETTING §
CORPORATION HEALTH AND § Court Below: Superior Court
WELFARE TRUST FUND, on behalf § of the State of Delaware
of themselves and all others similarly §
situated, § C.A. No. N04C-11-191
§
Plaintiffs Below, §
Appellants, §
§
v. §
§
ASTRAZENECA §
PHARMACEUTICALS LP; AND §
ZENECA, INC., §
§
Defendants Below, §
Appellees. §
Submitted: March 2, 2016
Decided: April 12, 2016
Before HOLLAND, VALIHURA, and SEITZ, Justices.
Upon appeal from the Superior Court. AFFIRMED.
Uriel Rabinovitz, Esquire (argued), Barbara J. Hart, Esquire, Scott V. Papp, Esquire,
Lowey Dannenberg Cohen & Hart, P.C., White Plains, New York, Pamela S. Tikellis,
Esquire, A. Zachary Naylor, Esquire, Tiffany J. Cramer, Esquire, Chimicles & Tikellis
LLP, Wilmington, Delaware, Ellen Meriwether, Esquire, Bryan L. Clobes, Esquire,
Cafferty Clobes Meriwether & Sprengel LLP, Philadelphia, Pennsylvania, L. Kendall
Satterfield, Esquire, Finkelstein Thompson LLP, Washington, D.C., Robert S. Schachter,
Esquire, Dan Drachler, Esquire, Zwerling, Schachter & Zwerling, LLP, New York, New
York, Jeffrey L. Kodroff, Esquire, Spector Roseman Kodroff & Willis, PC, Philadelphia,
Pennsylvania, for Plaintiffs Below, Appellants Teamsters Local 237 Welfare Fund.
Michael P. Kelly, Esquire (argued), Daniel M. Silver, Esquire, McCarter & English LLP,
Wilmington, Delaware, Jack B. Jacobs, Esquire, Sidley Austin LLP, Wilmington,
Delaware, Mark E. Haddad, Esquire, Joshua E. Anderson, Esquire, David R. Carpenter,
Esquire, Sidley Austin LLP, Los Angeles, California, for Defendants Below, Appellees
AstraZeneca Pharmaceuticals LP, and Zeneca, Inc.
SEITZ, Justice:
I. INTRODUCTION
A group of New York-based third party payor health insurers (“TPPs”) that
provide prescription drug benefits to union members appeal from a Superior Court
judgment dismissing with prejudice their second amended complaint. At issue are claims
brought by the TPPs under various state consumer fraud laws against AstraZeneca
Pharmaceuticals LP, and Zeneca Inc. (collectively “AstraZeneca”). The TPPs allege that
AstraZeneca falsely advertised its more expensive patented prescription drug Nexium as
superior to the less expensive generic drug Prilosec, causing the TPPs to overpay for
Nexium when generic Prilosec would have sufficed to treat their conditions.
After conducting an extensive choice of law analysis, the Superior Court
determined that New York law controlled the TPPs’ claims. The court then held that the
TPPs failed to state a claim under New York’s consumer fraud statute for failure to allege
legally sufficient causation. According to the Superior Court, a physician’s expertise in
prescribing drugs for a patient’s condition broke the causation chain between the
advertising and the injury. The Superior Court denied leave to amend and dismissed the
action with prejudice.
On appeal, the TPPs first focus on the Superior Court’s choice of law analysis, and
claim that Delaware law, not New York law, should govern their claims because
Delaware has a closer connection to the claims. Second, the TPPs argue that the Superior
Court erred in its causation analysis because the physician’s decision to prescribe the
higher-priced Nexium based on the allegedly false advertising, when lower-priced
3
Prilosec supposedly would do, directly injured them by forcing them to pay higher
prescription drug costs.
After a careful review of the record on appeal, we affirm the ultimate judgment of
the Superior Court. We need not decide whether the Superior Court correctly analyzed
the choice of law issue, because under either state consumer fraud statute the TPPs
cannot recover damages as a matter of law. Before recovering damages, both statutes
require that the TPPs must be a victim of, or be injured “by reason of” or “as a result of”
the allegedly false advertising. The TPPs cannot meet this standard of causation because
any injury they suffered was self-inflicted. Obviously aware of the false advertising
claims they brought in this litigation, the TPPs nonetheless continued to list Nexium on
their formularies and continued to reimburse members for Nexium prescriptions during
the many years this litigation was pending. Neither statute would recognize a consumer
fraud claim to recover damages where a party claiming to be injured caused its own
injury. Because the TPPs’ claims fail as a matter of law, we affirm the Superior Court’s
dismissal of the amended complaint with prejudice.
II. STATEMENT OF FACTS AND PROCEDURAL HISTORY
The Facts Alleged in the Superior Court Second Amended Complaint
Omeprazole is a chemical compound belonging to a class of proton-pump
inhibitors (“PPIs”) used to treat heartburn and erosion of the esophagus. AstraZeneca
patented the chemical compound, which gave it a period of exclusivity to market and to
sell the heartburn medicine free from competition by generic drug manufacturers. By the
4
year 2000, AstraZeneca’s “purple pill” Prilosec, the trade name for omeprazole, was a top
selling drug with annual sales of $6 billion.
The TPPs allege that in 2001 AstraZeneca faced a looming patent expiration
deadline for Prilosec, meaning that generic competition was free to enter the market,
severely affecting Prilosec’s profitability. According to the TPPs, to combat the profit
decline caused by generic competition, AstraZeneca introduced Nexium, a new patented
PPI drug therapeutically identical to omeprazole but containing twice the amount of
active ingredient. AstraZeneca marketed Nexium to doctors and the general public as
superior to Prilosec in the hope that it would displace Prilosec in the PPI market. The
TPPs alleged that the marketing campaign touting Nexium’s superiority proved a
resounding success, with Nexium achieving worldwide sales of $3.9 billion in 2012. The
end result of AstraZeneca’s false marketing campaign, say the TPPs, was “unlimited
access to TPPs’ treasuries, who paid billions of dollars for Nexium rather than the
cheaper and therapeutically equivalent generic Prilosec.”1
On November 18, 2004, the TPPs filed this action against AstraZeneca in the
Superior Court on behalf of themselves and a putative nationwide class of TPPs. The
action then slumbered under a stipulated stay while essentially identical consolidated
class actions involving many of the same counsel but different plaintiffs proceeded in the
United States District Court for the District of Delaware.
1
Opening Br. at 7.
5
The Federal Court Litigation
On May 27, 2005, the plaintiffs in three federal cases filed a consolidated class
action complaint on behalf of a nation-wide class of consumers and TPPs. Following a
series of dismissals and appeals and a remand consuming half a decade,2 the federal court
plaintiffs filed an amended consolidated class action complaint in 2009, with counts for
violations of the Delaware Consumer Fraud Act and the consumer fraud statutes of the
other states, unjust enrichment, and negligent misrepresentation.
In a May 6, 2010 decision the District Court dismissed all of the plaintiffs’
claims.3 The District Court confronted complex choice of law issues where plaintiffs
from diverse states sought relief under various theories of recovery, including under state
consumer fraud statutes. As a first step in the choice of law analysis, the court evaluated
whether an actual conflict existed among the many consumer fraud statutes raised in the
litigation. Pertinent to the case before us, the District Court found an actual conflict
between the New York and Delaware statutes.
According to the District Court, under New York law, “a plaintiff alleging a claim
for deceptive advertising under [the consumer fraud statute] must plead some awareness
of the advertising itself in order to state a claim.”4 By contrast, under Delaware law,
“Delaware courts have found that a plaintiff can assert a cognizable claim under [the
2
Pa. Emp. Benefit Trust Fund v. Zeneca, Inc., 2005 WL 2993937 (D. Del. Nov. 8, 2005), aff’d,
499 F.3d 239 (3d Cir. 2007), judgment vacated, 556 U.S. 1101 (2009).
3
Pa. Emp., Benefit Trust Fund v. Zeneca, Inc., 710 F. Supp. 2d 458 (D. Del. 2010) [hereinafter
“Zeneca”].
4
Id. at 474.
6
Delaware Consumer Fraud Act] even where allegations of reliance are wholly lacking.”5
The conflict led the District Court to apply the “most significant relationship test” of the
Restatement.6 The District Court reviewed the various factors of the Restatement test and
concluded that New York rather than Delaware law had the most significant relationship
with the claims by one of the plaintiffs.
Applying New York law, the District Court discussed the “nuanced” relationship
between reliance and causation under New York’s consumer fraud statute. Although
reliance is not a necessary element to state a claim under the statute, when it comes to
causation and recovery of damages, a “plaintiff need not show that the defendant’s
misrepresentation was the sole impetus behind the decision to purchase a product, but the
plaintiff cannot be wholly unaware of the misrepresentation prior to making the decision
to purchase.”7 The plaintiffs argued that the defendant’s misrepresentations caused the
injury because patients paid an inflated price for what they thought was a superior
product. But, as the District Court held, the argument presupposes that the plaintiffs were
aware of the efficacy representations prior to purchasing Nexium, which was not pled in
the amended complaint. Based on the lack of awareness, and as a consequence lack of
causation, the District Court dismissed the plaintiffs’ consumer fraud claim under New
York law. The court also dismissed all other claims in the amended complaint, with
5
Id.6
RESTATEMENT (SECOND) OF CONFLICT OF LAWS §§ 145, 148 (1971).
7
Zeneca, 710 F. Supp. 2d at 481.
7
leave to amend. The plaintiffs chose not to amend their claims, and the dismissal became
final.
The Superior Court Action Resumes
While the federal court litigation proceeded, the TPPs repeatedly requested, to no
avail, that the Superior Court lift the stay. The TPPs asked the court to lift the stay for
the last time on August 16, 2010, after the District Court’s judgment became final. Due
to an administrative error by the court, the case continued to languish until February 6,
2014, when the Superior Court finally lifted the stay.
The TPPs filed their second amended complaint in the Superior Court on April 10,
2014. They alleged violations of the Delaware Consumer Fraud Act, violations of the
consumer fraud laws of fourteen other states, unjust enrichment, and negligent
misrepresentation. Following AstraZeneca’s unsuccessful attempt to remove the case to
federal court, AstraZeneca moved to dismiss the second amended complaint.
The Superior Court granted AstraZeneca’s motion.8 Relying on the District
Court’s choice of law analysis in Zeneca, the Superior Court found an actual conflict
between the New York and Delaware consumer fraud statutes, conducted a choice of law
analysis, and determined that New York law applied. Applying New York law, the court
found that the TPPs failed to state a claim. According to the Superior Court, the
“purported chain of causation that runs from the allegedly deceptive advertisements that
may have influenced the decisions of individual doctors to prescribe a drug to their
8
Teamsters Local 237 Welfare Fund v. Astrazeneca Pharm. LP, 2015 WL 4111826 (Del. Super.
July 8, 2015).
8
patients to causally affect the payer unions in this case is simply too attenuated.”9 The
court reasoned that many factors affect a prescribing physician’s decision to administer
medication, and “doctors are presumed to go beyond advertising medium and use their
independent knowledge in making medical decisions.”10 The court also dismissed the
TPPs’ unjust enrichment claim for failure to plead causation, and their negligent
misrepresentation claim for failure to plead reliance. This appeal followed. The TPPs
have limited their claims on appeal to consumer fraud and the dismissal with prejudice.
III. ANALYSIS
The Delaware and New York Consumer Fraud Statutes
We focus our attention, as the parties did in this appeal, on the consumer fraud
laws of Delaware and New York. The Delaware General Assembly enacted a consumer
fraud statute “to protect consumers and legitimate business enterprises from unfair or
deceptive merchandising practices in the conduct of any trade or commerce in part or
wholly within this State.”11 Under the statute, “[a] private cause of action shall be
available to any victim of a violation of this subchapter,”12 where:
[t]he act, use or employment by any person of any deception,
fraud, false pretense, false promise, misrepresentation, or the
concealment, suppression, or omission of any material fact
with intent that others rely upon such concealment,
suppression or omission, in connection with the sale, lease or
advertisement of any merchandise, whether or not any person
9
Id. at *8.
10
Id. (quoting Se. Laborers Health & Welfare Fund v. Bayer Corp., 655 F. Supp. 2d 1270, 1281
(S.D. Fla. 2009), aff’d, 444 F. App’x 401 (11th Cir. 2011)).
11
6 Del. C. § 2512.
12
Id. § 2525(a).
9
has in fact been misled, deceived or damaged thereby, is an
unlawful practice.13
Accordingly, to bring a private cause of action for damages under the Delaware
Act, a plaintiff must allege three elements: (1) a defendant engaged in conduct which
violated the statute; (2) the plaintiff was a “victim” of the unlawful conduct; and (3) a
causal relationship exists between the defendant’s unlawful conduct and the plaintiff’s
ascertainable loss.14 We have noted before the three ways in which the Delaware
Consumer Fraud Act differs from traditional legal and equitable actions for fraud,
misrepresentation, and deceit. First, “the only intent requirement of the Act is that in
omitting or concealing a material fact, the defendant must have intended that others rely
on the omission or concealment.”15 Second, “an unlawful practice . . . is committed
regardless of actual reliance by the plaintiff.”16 And third, “any misrepresentation had to
be made with the intent to induce action or inaction by the plaintiff[, but t]he statute does
not require proof of such intent.”17 In all other respects, “the statute must be interpreted
in light of established common law definitions and concepts of fraud and deceit.”18
The New York State Legislature has enacted a similar consumer fraud law. Under
its statute, “[d]eceptive acts or practices in the conduct of any business, trade or
commerce or in the furnishing of any service in this state are hereby declared unlawful,”
and “any person who has been injured by reason of any violation of this section may
13
Id. § 2513(a).
14
Id. §§ 2513, 2525.
15
Stephenson v. Capano Dev., Inc., 462 A.2d 1069, 1074 (Del. 1983).
16
Id.17
Id.18
Id.10
bring an action in his own name to enjoin such unlawful act or practice, an action to
recover his actual damages or fifty dollars, whichever is greater, or both such actions.”19
To establish a violation of the New York statute, a plaintiff must prove “first, that the
challenged act or practice was consumer-oriented; second, that it was misleading in a
material way; and third, that the plaintiff suffered injury as a result of the deceptive
act.”20 Like Delaware’s Act, “[a] deceptive practice . . . need not reach the level of
common-law fraud to be actionable [and] a plaintiff must prove ‘actual’ injury to recover
under the statute, though not necessarily pecuniary harm.”21 Further, “reliance is not an
element” of a New York Consumer Fraud Act claim.22
Injury and Causation Under the New York and Delaware Consumer Fraud Laws
Although neither statute requires that a plaintiff actually rely on the false
advertising before stating a claim, both statutes require that the false advertising cause the
plaintiff’s injury.23 The causation requirement is grounded in the language of each
statute. In New York, the plaintiff must be injured “by reason of” a violation of the
consumer fraud statute.24 In Delaware, a private right of action is available to a “victim
of a violation” of the Act.25 Thus, the violation must have “caused” harm to the person
19
N.Y. GEN. BUS. LAW § 349.
20
Stutman v. Chem. Bank, 731 N.E.2d 608, 611 (N.Y. 2000).
21
Id. at 612.
22
Id.
23
6 Del. C. § 2513(a) (“The act, use or employment by a person of any deception . . . whether or
not any person has in fact been misled . . . is an unlawful practice.”) (emphasis added); Stutman,
731 N.E.2d at 612 (recognizing that a plaintiff is not required to prove individual reliance upon a
defendant’s deceptive practice independently in order to state a claim under GBL 349).
24
N.Y. GEN. BUS. LAW § 349(h); Stutman, 731 N.E.2d at 611.
25
6 Del. C. § 2525(a).
11
bringing the action for violation of the act, or the person would not be a “victim.”26
Additionally, the Delaware statute, when addressing damages where a receiver is
involved, states that the injured party must suffer harm “as a result of” the fraudulent
marketing activities.27 Whether or not a receiver is involved, causation has also long
been recognized as a requirement under the Delaware Consumer Fraud Act.28
The parties agree that the deceptive advertising must be the cause of the TPPs’
injury, but disagree about what that means. The TPPs argue that they were the ultimate
targets of AstraZeneca’s alleged fraud because they paid for the purportedly overpriced
prescriptions. Therefore TPPs, like consumers, allegedly suffered direct economic harm
caused by AstraZeneca’s misrepresentations when they overpaid for Nexium instead of
the equally efficacious and less expensive Prilosec.29 AstraZeneca responds that the
TPPs do not allege they were exposed to the false advertising, and therefore the
26
A “victim” is “a person harmed by a crime, tort, or other wrong.” BLACK’S LAW DICTIONARY
1703 (9th ed. 2009).
27
6 Del. C. § 2524(c).
28
See Stephenson, 462 A.2d at 1074 (“[Except for three specifically enumerated differences, the
Delaware Consumer Fraud Act] must be interpreted in light of established common law
definitions and concepts of fraud and deceit.”); id. at 1077 (“A plaintiff . . . may recover for any
injury resulting from the direct and natural consequences of his acting on the strength of the
defendant’s statements.”).
29
See In re Warfarin Sodium Antitrust Litig., 391 F.3d 516, 531 (3d Cir. 2004) (holding that
TPPs “suffered direct economic harm” when they overpaid as a result of misrepresentations for a
brand-name drug when an equivalent generic was available); Desiano v. Warner Lambert Co.,
326 F.3d 339, 349-50 (2d Cir. 2003) (“Consider . . . a hypothetical in which a defendant drug
company markets a ‘new,’ much more expensive drug claiming it is a great advancement . . .
when in fact the company is simply replicating [an old] formula and putting a new label on it.
[T]he insurance companies would be able to claim—precisely as they do here—that the
defendants engaged in a scheme to defraud it, and that the company suffered direct economic
losses as a result.”).
12
advertising could not have caused their injury.30 Further, AstraZeneca argues that even if
the TPPs were exposed to the advertising, the allegedly false advertising did not cause the
TPPs’ injury because other events intervened to make the connection between the
advertising and the harm too attenuated. For instance, like the Superior Court,
AstraZeneca points to the physician’s professional decision to prescribe the drug—which
is presumed to be made in the best interests of the patient—as a break in the causation
chain.31
30
See Gale v. Int’l Bus. Machs. Corp., 781 N.Y.S.2d 45, 47 (N.Y. App. Div. 2004) (a plaintiff
must at a minimum be aware of the false statements to plead causation with sufficient
specificity).
31
See McDowell v. Eli Lilly & Co., 58 F. Supp. 3d 391, 410-11 (S.D.N.Y. 2014) (holding
consumer fraud claims were defeated by adequate warning and failure to show proximate cause
by operation of the learned intermediary doctrine); In re Warfarin Sodium Antitrust Litig., 212
F.R.D. 231, 255-56 (D. Del. 2002), aff’d, 391 F.3d 516 (3d Cir. 2004) (“[T]o prove their . . .
consumer fraud claims, plaintiffs would . . . have to show these activities caused harm to
consumers and TPPs. [T]he learned intermediary doctrine presents a barrier to proving that any
deceptive representations made by defendant were the proximate cause of plaintiffs’ injuries.”);
see also UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121, 134 (2d Cir. 2010) (internal
citations omitted):
The TPP plaintiffs draw a chain of causation in which Lilly distributes
misinformation about [the drug], physicians rely upon that misinformation and
prescribe [it] for their patients, and then the TPPs overpay. This narrative skips
several steps and obscures the more attenuated link between the alleged
misrepresentations made to doctors and the ultimate injury to the TPPs. In fact, . .
. the chain of causation runs as follows: Lilly distributes misinformation about
[the drug], physicians rely upon the misinformation and prescribe [it], TPPs
relying on the advice of [pharmacy benefit managers to] place [the drug] on their
formularies . . . , TPPs fail to negotiate the price . . . below the level set by Lilly,
and TPPs overpay . . . . Thus, in this case “the conduct directly causing the harm
was distinct from the conduct giving rise to the fraud.” Plaintiffs’ “theory of
liability rests on the independent actions of third and even fourth parties . . . .”
13
To decide this appeal we need not engage in the lively debate about the scope of
causation and its interplay with state consumer fraud statutes.32 Instead, we rely on the
common sense notion that TPPs who claim that false advertising injured them, but
continue to cover the allegedly falsely advertised drug on their formularies and reimburse
members for prescriptions cannot, as a matter of law, establish that they were “injured by
reason of” or were victims of the false advertising.
The parties agree that under either the Delaware or the New York consumer fraud
statutes, the plaintiff must be a victim of or be injured by the allegedly false advertising
before damages can be recovered. Despite alleging in their 2004 complaint that
AstraZeneca falsely advertised Nexium as superior to Prilosec, the TPPs concede that
they continued to list Nexium on their formularies and to pay or reimburse their members
for Nexium.33 Under any reasonable interpretation of the statutes, TPPs who continue to
32
See, e.g., James D. Arden & Peter C. Brensilver, A Bitter Pill for Plaintiffs: Obstacles to
Market Theories of Causation in Prescription Drug Consumer Fraud Cases, 61 FOOD & DRUG
L.J. 539 (2006) (discussing the emergence of market theories of causation in the consumer fraud-
pharmaceutical context); Joseph J. Leghorn et al., Defending an Emerging Threat: Consumer
Fraud Class Action Suits in Pharmaceutical and Medical Device Products-Based Litigation, 61
FOOD & DRUG L.J. 519, 535 (2006) (“Despite the elimination or relaxation of other elements of a
typical common law fraud claim, nearly all of the states still require . . . a ‘causal nexus’ between
unfair or deceptive conduct and the plaintiff’s injury. On its face, this principle seems counter-
intuitive—particularly in jurisdictions where plaintiffs need not demonstrate reliance . . . . Courts
have struggled to craft standards that address this apparent paradox.”); Sheila B. Scheuerman,
The Consumer Fraud Class Action: Reining in Abuse by Requiring Plaintiffs to Allege Reliance
as an Essential Element, 43 HARV. J. ON LEGIS. 1 (2006). See generally Henry N. Butler &
Jason S. Johnston, Reforming State Consumer Protection Liability: An Economic Approach,
2010 COLUM. BUS. L. REV. 1 (2010) (discussing the functioning of consumer protection laws and
suggesting changes).
33
The TPPs allege that the proposed “Class” is composed of purchasers of Nexium during the
Class Period, which extended to March 25, 2010. The TPPs admitted at oral argument that they
continue to pay for Nexium, years after they came to believe it was a fraudulent product.
14
pay or reimburse for Nexium, while claiming they were harmed by allegedly false
advertising, are neither “victims” of the allegedly false advertising nor were they injured
by reason of or as a result of it. They were injured by their own conduct.34
The TPPs nonetheless claim that they were directly injured by the false
advertising, even though they believed the advertising was false and misleading, because
they were forced to pay a higher price for Nexium rather than the “market” price
reflecting its true value. In other words, the TPPs would have paid a lower “market”
price if all participants had been fully informed about the alleged equivalence of Nexium
and Prilosec. But the TPPs’ fraud-on-the-market theory has been rejected by other courts
Videotape: Oral Argument before the Delaware Supreme Court, at 7:03-8:10 (Teamsters Local
237 Welfare Fund v. AstraZeneca Pharm. LP, 415, 2015 (Del. Mar. 2, 2016)) (“Q: But once you
discovered . . . that Nexium was a ‘fraudulent product,’ I assume you immediately stopped
paying for it[?] A: No, your honor.”), archived at http://livestream.com/DelawareSupremeCourt/
events/4901943/videos/114082603.
34
See Prohias v. Pfizer, Inc., 485 F. Supp. 2d 1329, 1336 (S.D.N.Y. 2007) (under the Florida and
New York consumer fraud laws, plaintiffs who continued to pay for Lipitor with knowledge of
its alleged limitations were not “actually injured or aggrieved” by the allegedly misleading
advertisement); Heindel v. Pfizer, Inc., 381 F. Supp. 2d 364, 379 (D.N.J. 2004) (plaintiffs did not
suffer ascertainable economic loss because of their continued use of the drugs in question while
claiming a failure to disclose known risks). The TPPs claim that the Third Circuit’s recent
decision in In re Avandia Marketing, Sales Practices & Product Liability Litigation, 804 F.3d
633 (3d Cir. 2015), is to the contrary. But in Avandia the court rejected a similar claim because
the defendant “first asks us to assume, in the absence of contrary allegations, that plaintiffs did
not change their coverage of Avandia in 2007. At this stage, however, we do not know that this
is true.” Id. at 644. In the case before us, we know it to be true that the TPPs continued to list
Nexium on their formularies and to pay for or reimburse members for Nexium purchases. The
Avandia court also rejected the same argument because at the pleading stage it was not clear that
the full scope of the drug’s risks was known in 2007. Here, we do not address an information
void on side effects or risk profiles. Instead, the “full scope of the alleged fraud” was apparent
from the complaint, and the TPPs could have chosen to remove Nexium from their formularies
based on their claims.
15
as speculative because it does not represent the realities of the pharmaceutical market.35
No “market” in the traditional economic sense exists to set a price for prescription
drugs—pharmaceutical companies set prices in a heavily regulated environment with
little interplay between the laws of supply and demand.36 Further, even if market forces
set prescription drug prices, the TPPs elected to continue covering Nexium fully aware of
their false advertising claims. To recognize a fraud on the market theory in the present
context would ignore the TPPs culpability for their self-inflicted wound.
Finally, the TPPs argue that they were “forced” to cover Nexium because of the
overwhelming advertising pressure exerted by AstraZeneca directed towards physicians
and patients. Their argument is particularly unpersuasive given the role of TPPs in the
healthcare system, a large part of which is cost control.37 TPPs are structured to counter
35
E.g., Prohias, 485 F. Supp. 2d at 1337 (“I . . . reject the plaintiffs’ claim that they have been
injured by ‘price inflation’ because . . . [t]hey depend on the faulty premise that the price of
[drugs fluctuate] based on the public’s knowledge of [their] benefits, even though drug prices
(unlike stock prices which are necessarily set by the price at which buyers are willing to buy, or
sellers willing to sell) are fixed by the product’s manufacturer.”); Int’l Union of Operating
Eng’rs Local No. 68 Welfare Fund v. Merck & Co., 929 A.2d 1076, 1088 (N.J. 2007) (“[T]he
fraud on the market theory [is] inappropriate in any context other than federal securities fraud
litigation. Therefore, to the extent that plaintiff seeks to prove only that the price charged for
[the drug] was higher than it should have been as a result of defendant’s fraudulent marketing
campaign, . . . the theory must fail.”); Heindel, 381 F. Supp. 2d at 380 (“[The fraud-on-the-
market theory in the pharmaceutical context] is patently absurd. . . . [T]here is no prescription
drug ‘market,’ at least as that term is understood in the securities context.”).
36
See Arden & Brensilver, supra note 32, at 542 (“The fraud-on-the-market theory presumes the
existence of an ‘impersonal, well-developed’ market for the product. . . . In the securities
context, the presumption is that any material misrepresentations will lead to an artificially
inflated price because a security is price-sensitive to all public information. In contrast, a
prescription drug is not constantly re-priced on the basis of the current mix of information in the
market, as there is no strong correlation between the price and the demand for the product.”
(quoting Basic Inc. v. Levinson, 485 U.S. 224, 247 (1988))).
37
As the Third Circuit observed in Avandia:
16
pharmaceutical company pressure on physicians and patients to prescribe and to use more
expensive branded drugs where generics will do. TPPs can incent physician and patient
behavior by not listing a drug on their formularies, or by offering financial incentives to
use less expensive and equally effective generic medicines. The TPPs chose not to do so
here while fully aware of their false advertising claims. That was their business decision
to make. But they cannot then recover damages under either consumer fraud statute for
the harm they inflicted on themselves.
Dismissal with Prejudice
Given the basis for our disposition of this appeal, leave to amend in the Superior
Court would have been futile.38 Therefore, we affirm the Superior Court’s dismissal of
this action with prejudice.
Whether a TPP will cover the cost of a member’s prescription, in whole or in part,
depends on whether that drug is listed in the TPP’s “formulary.” Pharmacy
Benefit Managers (PBMs) prepare TPPs’ formularies of drugs approved for use
by the TPPs’ members. The formularies are prepared by analyzing research
regarding a drug’s cost effectiveness, safety and efficacy. When a PBM
determines that a drug offers advantages over a competing drug, it will give that
drug preferred status on the formulary. A TPP will typically cover more of the
cost of a particular drug when that drug has a higher preference status on the
formulary. The greater coverage of cost by the TPP allows the member to pay a
lower co-payment when prescribed that drug.
804 F.3d at 634-35; see also UFCW Local 1776, 620 F.3d at 126, 134 (“[O]nly the TPPs were in
a position to negotiate the price paid for [the drug.]”).
38
See Clark v. State Farm Mut. Auto. Ins. Co., -- A.3d --, 2016 WL 125432, at *7 (Del. Jan. 11,
2016).
17