Plaintiffs Aetna Inc. and Aetna Health Management, LLC (collectively, "Aetna" or "Plaintiffs"), filed suit against Insys Therapeutics, Inc., several of its current and former executives, and multiple named and unnamed physicians, alleging a conspiracy to fraudulently induce Aetna into providing reimbursement for off-label prescriptions of Insys's opioid product, Subsys. Insys moves to dismiss Aetna's common law claims on federal preemption and state law grounds and moves to strike certain allegations from the Complaint. Former sales executives Joseph Rowan and Sunrise Lee move to dismiss Aetna's claims against them for lack of personal jurisdiction and failure to state a claim. Lee also moves to dismiss for insufficient service of process. Dr. Steve Fanto moves to dismiss for lack of personal jurisdiction. For the reasons discussed below, Insys's motion will be denied in part and granted in part, and Fanto, Rowan, and Lee's motions will be granted.
I. BACKGROUND
Defendant Insys is the Arizona-based manufacturer of Subsys, a formulation of
Plaintiff Aetna Inc., a Pennsylvania corporation with its principal place of business in Hartford, Cоnnecticut, is a health management organization that provides health payment benefits to members throughout the United States. Plaintiff Aetna Health Management, LLC, a Delaware limited liability company, is a subsidiary of Aetna Inc. that develops and operates group health insurance products and pays claims and benefits incurred by Aetna members, including pharmacy claims for prescription drugs.
Subsys was not listed among the drugs approved for reimbursement in Aetna's formularies. To obtain coverage for prescriptions of Subsys, Aetna required its member patients to obtain prior authorization from its Pharmacy Management Precertification Unit (the "PMPU"), which applied the following criteria, with limited exceptions,
Despite Subsys's limited FDA-approved indication, the restrictions placed on its distribution and coverage by the FDA and insurers, and the availability of less expensive generic TIRF alternatives, the drug gained a substantial share of the TIRF market within a few years of its launch. While sales of Subsys in 2012 were only $14.3 million, sales increased more than 700% in 2013 and exceeded more than $300 million by 2014.
Aetna alleges that the rapid increаse in Insys's sales was due to a two-pronged scheme in which Insys encouraged physicians to overprescribe Subsys for non-FDA approved (or "off-label") uses and defrauded insurers into providing coverage for the off-label prescriptions. Specifically, Plaintiffs allege that Insys targeted its promotional efforts toward physicians who did not treat cancer patients but frequently prescribed TIRFs, and recruited physicians willing to write large numbers of Subsys prescriptions into Insys's speaker program, under which speakers received substantial payments as honoraria. To increase the rate of reimbursement for Subsys prescriptions, Insys established a pre-authorization department ("PAD") based in Chandler, Arizona that communicated directly with insurers, including Aetna. Insys distributed "opt-in" forms to medical offices thаt authorized prescribers to send patients' medical information to the PAD, allowing the PAD staff to discuss patients' medical conditions and histories with the insurers. Aetna alleges that the PAD used this information to impersonate personnel working at physicians' offices and disguised the area code of the PAD facility during phone calls to avoid detection. To meet pre-certification requirements, the PAD staff allegedly misrepresented to
In several state and federal investigations conducted between 2015 and 2017, a number of physicians who had prescribed Subsys to patients admitted that they had prescribed the drug inappropriately and that they had received payments from Insys as part of its speaker program. According to an internal review conducted by Aetna in the fall of 2015, the majority of Aetna members who had received prior authorization for Subsys did not have a cancer diagnosis.
A. Lee and Rowan
Defendants Lee and Rowan were sales executives at Insys responsible for the promotion of Subsys to potential prescribers. Rowan, who resided in Florida, served as Regional Sales Manager for the Southeast Region and Regional Director for the Eastern Region. Lee, who resided and continues to reside in Michigan, served as Regional Sales Manager for the Mid-Atlantic Region, Regional Director for the Centrаl Region, and Regional Director for the West Region. Plaintiffs allege that Lee, Rowan, and others provided payments and "other forms of kickbacks" through Insys's speaker program to health care providers who agreed to prescribe Subsys off-label. Plaintiffs also allege that some practitioners who received speaking fees and prescribed Subsys for off-label use were located in Pennsylvania, including one prescriber specifically identified in the Complaint as "Prescriber 2."
B. Fanto
Fanto is a physician who operated a medical practice in Arizona.
Plaintiffs assert the following claims against all Defendants: insurance fraud in violation of 18 Pa. C.S.A § 4117(a)(2) (Count I); aiding, abetting, soliciting, and conspiring to commit insurance fraud in violation of 18 PA. C.S.A. § 4117(a)(3) (Count II); civil conspiracy (Count III); common law fraud (Count IV); unjust enrichment (Count V); negligent misrepresentation (Count VI); and negligence (Count VII).
II. LEGAL STANDARDS
A. Federal Rule of Civil Procedure 12(b)(2)
Pursuant to Federal Rule of Civil Procedure 12(b)(2), а court must grant a defendant's motion to dismiss if the court lacks personal jurisdiction over the defendant.
A district court typically exercises personal jurisdiction according to the law of the state where it sits.
Jurisdiction may be general or specific in nature.
B. Federal Rule of Civil Procedure 12(b)(6)
Pursuant to Federal Rule of Civil Procedure 12(b)(6), dismissal of a complaint for failure to state a claim upon which relief can be granted is appropriate
III. DISCUSSION
A. Personal Jurisdiction
1. Fanto's Motion
Fanto moves to dismiss all claims against him for lack of personal jurisdiction, asserting that he has never practiced medicine in Pennsylvania, has not visited Pennsylvania in over 20 years, has never directed marketing efforts towards Pennsylvania, did not have an in-network provider contract with Aetna, and did not submit out-of-network claims to Aetna at any Pennsylvania address.
Co-conspirator jurisdiction is not a separate basis of jurisdiction apart from general or specific jurisdiction.
Here, Plaintiffs have alleged that Fanto conspired with Insys and others to
For these reasons, Dr. Fanto's motion is granted, and all claims against him are dismissed for lack of personal jurisdiction.
2. Rowan and Lee's Motions
Defendants Rowan and Lee also move to dismiss for lack of personal jurisdiction. In asserting jurisdiction, Plaintiffs rely both on the effect of Rowan and Lee's own alleged activities in Pennsylvania and on the co-conspirator theory of jurisdiction.
Courts apply the "effects test" from Calder v. Jones ,
In asserting that Rowan and Lee purposefully directed activities toward
These connections between Defendants and Pennsylvania are too attenuated to establish purposeful availment under Calder . First, Plaintiffs have not alleged facts to establish that they suffered the brunt of the harm from Defendants' conduct in Pennsylvania. While Plaintiffs assert that they paid reimbursements for patients located in Pennsylvania, the Complaint does not allege that this is the location where Plaintiffs relied on Defendant's misrepresentation or the location where Plaintiffs suffered economic loss.
Moreover, Plaintiffs cannot assert conspiracy jurisdiction over Rowan or Lee because the Complaint does not sufficiently allege facts to support that either Defendant entered into an actionable conspiracy.
Accordingly, Rowan's and Lee's Motions to Dismiss for lack of personаl jurisdiction will be granted, and the Court need not reach these Defendants' other asserted grounds for dismissal.
3. Insys's Motion to Dismiss
1. Preemption
The doctrine of preemption is rooted in the Supremacy Clause of the United States Constitution, which provides that the "Constitution, and the laws of the United States...shall be the supreme Law of the Land."
There are three primary forms of preemption: (1) "express" preemption, when Congress explicitly states its intent to preempt state law; (2) "field" preemption, when Congress' intent to preempt state law in particular area is inferred from either the comprehensive scheme of federal regulation in that area or the dominant federal interest in that area; and (3) "conflict" or "implied" preemption, when "state law is nullified to the extent that it actually conflicts with federal law," even though Congress has not displaced all state law in that area.
Under a fair reading of the Complaint, however, Plaintiffs' common law claims do not "arise solely from" Insys's alleged off-label promotion of Subsys and are "not based simply on some regulatory duty owed to the FDA, the breach of which caused injury to the Plaintiffs."
Insys also moved the Court, in the alternative, to dismiss Plaintiffs' common law claims on the ground that the FDCA creates no private right of action against off-label promotion.
2. Economic loss doctrine
Insys contends that all of Plaintiffs' common law claims are barred by the economic loss doctrine because they rely solely on economic damages in the absence of physical injury or property damage. Under Pennsylvania law, the doctrine provides that "no cause of action exists for negligence that results solely in economic damages unaccompanied by physical injury or property damage."
Pennsylvania courts have generally applied the economic loss doctrine to
In asserting that the doctrine is limited to claims arising from contractual duties, Plaintiffs rely primarily on Bilt-Rite Contractors, Inc. v. The Architectural Studio ,
Plaintiffs urge the Court to interpret Bilt-Rite as exemрting all tort claims arising independently of contractual duties from the economic loss doctrine.
The parties further disagree as to whether the economic loss doctrine extends beyond negligence-based torts to intentional torts such as Plaintiffs' common law fraud and conspiracy claims.
Additionally, Defendants have provided nо authority for applying the economic loss doctrine to unjust enrichment claims under Pennsylvania law, and the Court is aware of none. Thus, the Court will not dismiss Count V on this ground.
3. Civil Conspiracy
Insys contends that Plaintiffs failed to state a civil conspiracy claim because the Complaint does not allege that Insys acted with the requisite malice. In particular, Insys contends that malice exists only when "the sole purpose of the conspiracy was to injure the Plaintiffs,"
The parties, and courts in this District, disagree over whether motivations of personal or professional gain negate malice for purposes of establishing civil conspiracy.
Proof of malice, i.e. , an intent to injure, is essential in proof of a conspiracy. This unlawful intent must be absent justification. The test was stated in Rosenblum v. Rosenblum ,, 320 Pa. 103 , 585 (1935) : 181 A. 583
Assume that what is done is intentional, and that it is calculated to do harm to others. Then comes the question, Was it done with or without "just cause or excuse"? If it was bona fide done in the use of a man's own property...such legal justification would...exist not the less because what was done might seem to others to be selfish or unreasonable....But such legal justification would not exist when the act was merely done with the intention of causing temporal harm, without reference to one's own lawful gain, or the lawful enjoyment of one's own rights.
There arе no facts of record which indicate that [the defendant] acted solely to injure [the plaintiffs]. To the contrary, there are many facts which indicate that [the defendant] acted solely to advance the legitimate business interests of his client and to advance his own interests.63
While some courts have construed this language as requiring proof that the alleged conspirators acted "solely to injure" the plaintiffs, with no objective of personal gain,
Here, Plaintiffs assert that Insys conspired with physicians to defraud Aetna into authorizing reimbursements for Subsys. At this stage, if the Court accepts as true that Insys employees acted within the scope of their employment and intentionally used false information to induce Aetna to pay claims it otherwise would not have paid, then the Court can reasonably infer that Insys harbored sрecific intent to injure Aetna that satisfies the malice element of a civil conspiracy claim.
For these reasons, Insys's Motion to Dismiss Count III will be denied.
4. Unjust Enrichment
To state a claim for unjust enrichment under Pennsylvania law, a plaintiff must demonstrate that it conferred a benefit on the defendant, that the defendant knew of the benefit and accepted or retained it, and that it would be inequitable to allow the defendant to keep the benefit without paying for it.
Insys argues that Aetna has failed to allege that it conferred a benefit on Insys to Aetna's detriment. The Complaint alleges that Aetna paid for prescriptions of Subsys based on misrepresentations made by Insys concerning the indication for which the drug was prescribed and that Insys gained sales revenue and market share as a result of these prescriptions. Courts have found similar facts to satisfy the benefit element of an unjust enrichment claim under Pennsylvania law.
5. Punitive Damages
Insys moves to dismiss Plaintiffs' request for punitive damages essentially on the same grounds that it seeks to dismiss Plaintiffs' common law fraud claim. Because the Court will not dismiss Plaintiffs' common law fraud claim at this stage of the case, Plaintiffs' request for punitive damages may also proceed.
4. Insys's Motion to Strike
Federal Rule of Civil Procedure 12(f) allows a district court, in its discretion, to "strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter."
Here, Defendants seek to strike the following paragraphs of the Complaint: ¶¶ 42-47 (discussing the national opioid epidemic); ¶ 54 (quoting the FDA commissioner on regarding the impact of off-label promotion of drugs on public health); ¶ 55 (quoting the Inspector General of the U.S. Department of Health and Human Services on his opinion on the impact of off-label promotion on the drug approval process and medical decision-making); ¶¶ 96-99, 101 (discussing Insys's settlements with Oregon, New Hampshire, and Illinois attorneys general and ongoing litigation with the Arizona attorney general regarding off-label promotion of Subsys). While neither the national opioid crisis nor the practice of off-label drug promotion forms the actionable crux of Plaintiffs' claims, the Court is not persuaded that these facts "have no possible relation to the controversy"
IV. CONCLUSION
For the reasons discussed, Defendants Fanto, Rowan, and Lee's Motions to Dismiss for lack of personal jurisdiction will be granted, and Insys' Motion to Dismiss will be granted with respect to Plaintiffs' negligent misrepresentation and negligence claims (Counts VI and VII), and denied in all other respects. Insys's Motion to Strike will be denied.
An order follows.
Notes
The following facts, alleged in the Complaint, are assumed to be true for purposes of this Motion unless otherwise stated.
California patients could obtain coverage for Subsys with a diagnosis of a terminal illness other than cancer.
Compl. at ¶¶ 219-223.
Id. at ¶ 117.
Id. at ¶ 24; Fanto Aff. ¶¶ 20-26.
Compl. at ¶ 205.
Id. at ¶ 199, 201.
Id. at ¶ 206.
O'Connor v. Sandy Lane Hotel Co. ,
Time Share Vacation Club v. Atlantic Resorts, Ltd. ,
Mellon Bank (East) PSFS, Nat'l Ass'n v. Farino ,
De Lage Landen Fin. Servs., Inc. v. Rasa Floors, LP ,
O'Connor ,
AAMCO Transmissions, Inc. v. Romano ,
Remick v. Manfredy ,
Goodyear Dunlop Tires Operations, S.A. v. Brown ,
O'Connor v. Sandy Lane Hotel Co. ,
Bell Atl. Corp. v. Twombly ,
ALA, Inc. v. CCAIR, Inc .,
Twombly ,
Pension Ben. Guar. Corp. v. White Consol. Indus., Inc. ,
Fanto Decl. at ¶¶ 3-8, 20-26.
Mass. Sch. of Law at Andover, Inc. v. Am.Bar Ass'n ,
Mass. Sch. of Law at Andover, Inc. ,
Pl.'s Br. in Opposition to Fanto and Rowan's Mot. to Dismiss at 14 (citing Compl. ¶¶ 219-23).
Personal jurisdiction is assessed on a claim specific basis, see Remick v. Manfredy ,
Pl.'s Br. in Opp. to Rowan and Fanto's Motion at 13 (citing Compl. ¶¶ 20, 92), Pl.'s Opp. to Lee's Motion at 7 (citing Compl. ¶¶ 19, 22).
Compl. ¶¶ 219-23.
Neither Plaintiff alleges that it is headquartered in Pennsylvania, conducted review of authorization requests in Pennsylvania, or received or paid claims through a location in Pennsylvania.
Pl.'s Br. in Opp. to Rowan and Fanto's Motion at 13; Pl.'s Br. in Opposition to Lee's Motion at 7.
Arrow Med. Equip. Co. ,
Kline v. Sec. Guards, Inc.,
Montgomery Cnty., Pa. v. MERSCORP, Inc.,
U.S. Const. art. VI, cl. 2.
Knipe v. SmithKline Beecham ,
In re Tylenol (Acetaminophen) Mktg. , No. 2436,
Zafarana v. Pfizer, Inc. ,
Excavation Techs., Inc. v. Columbia Gas Co. of Pennsylvania ,
Excavation Technologies, Inc. ,
Debbs v. Chrysler Corp.,
See Am. Stores Properties, Inc. v. Spotts, Stevens & McCoy, Inc. ,
Id. at 484,
Plaintiffs misattribute the statement that the doctrine applies "only in cases where the source of the duty plaintiff seeks to enforce arises from a contract and, even then, only instances where the harm suffered is limited to economic loss arising from the interference with contractual expectation" to Bilt-Rite . Pl.'s Br. in Opposition to Insys's Motion at 8. The quote comes from a party's interpretation of Bilt-Rite as quoted in Longenecker-Wells v. Benecard Servs. Inc ,
See Longenecker-Wells v. Benecard Servs. Inc ,
See Excavation Technologies, Inc. ,
As discussed further below, civil conspiracy is an intentional tort because it requires specific intent to injure the plaintiff.
Werwinski v. Ford Motor Co.,
Zafarana ,
Compare, e.g. , Zafarana ,
Id. at 472 (citations omitted).
See, e.g. , Zafarana ,
See Ozburn-Hessey Logistics ,
See PDC Machines Inc. ,
See Giordano v. Claudio ,
Mitchell v. Moore,
Zafarana ,
See TAP Pharm. Prod., Inc. ,
Glob. Ground Support, LLC v. Glazer Enterprises, Inc. ,
Fed. R. Civ. P. 12(f).
DeLa Cruz v. Piccari Press ,
DeLa Cruz ,
