In re Remicade Antitrust Litig.
This text of 345 F. Supp. 3d 566 (In re Remicade Antitrust Litig.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
Joyner, District Judge
Before the Court are Defendants' Johnson & Johnson and Janssen Biotech, Inc. (collectively "Janssen") ("J & J") Motion to Dismiss for failure to state a claim under Fed. R. Civ. P. 12(b)(6) (Doc. No. 67-1), Indirect and Direct Purchaser Plaintiffs' Joint Opposition thereto (Doc. No. 73), and Defendants' Reply in Support thereof (Doc. No. 75).
I. Background
This case arises from an antitrust action brought by Direct and Indirect Purchasers of Defendants' drug Remicade, against Johnson & Johnson, along with its wholly owned subsidiary, Janssen Biotech, Inc. (collectively, "J & J"), alleging artificially inflated prices and monopolization of the pharmaceutical market for biologic infliximab drugs. The Direct and Indirect Purchasers' principle claim is that J & J undertook an anticompetitive scheme, consisting of exclusive agreements and coercive bundled rebates, to foreclose competition posed by biosimilar versions of Remicade, specifically Pfizer's Inflectra and Merck's Renflexis. The scheme allegedly caused providers and insurers to pay overcharges for infliximab products that they would not have paid absent J & J's anticompetitive conduct.
Under consideration is J & J's Motion to Dismiss the Indirect Purchasers' Consolidated Amended Complaint and to Dismiss *574the Amended Direct Purchaser Class Action Complaint for failure to state a claim under Fed. R. Civ. P. 12(b)(6) (Doc. No. 67-1). This Motion is fully briefed and ripe for the Court's adjudication. The Court has considered the parties' submissions and decides this matter without oral argument. Fed. R. Civ. P. 78 ; Loc. R. Civ. P. 7.1(f).
II. Alleged Facts
This case arises from essentially the same facts that have been described in detail in this Court's related decision denying Defendants J & J's motion to dismiss Pfizer's complaint alleging federal antitrust violations. Pfizer Inc. v. Johnson & Johnson,
The medications at the center of this litigation are biologic infliximab products, used as treatment for maintaining chronic auto-immune inflammatory conditions. Dir. AC ¶ 2, ¶ 41. Infliximab products cannot be taken orally and are only administered intravenously, generally by an in-office health care provider. Id. at ¶ 5. J & J's drug Remicade was the first biologic infliximab to enter the market in 1998. Ind. CAC ¶ 21. In 2009, Congress enacted the Biologic Price Competition and Innovation Act (BPCIA), an analog to the shortcut for FDA approval that the Hatch-Waxman amendments provide for chemically synthesized medications. Dir. AC ¶ 8-9. To attain approval as a "biosimilar" under the BPCIA, a manufacturer must demonstrate that "there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency." Ind. CAC ¶ 38. Once J & J's patent on Remicade expired in 2016, the FDA approved three other medications including Pfizer's Inflectra and Merck's Renflexis. Dir. AC ¶ 16-19, Ind. CAC ¶ 4. Competition from the introduction of biosimilars into the infliximab market was expected to lower prices for potentially lifesaving biologic medications that otherwise might have been unaffordable for some patients.2 Dir. AC ¶ 14, ¶ 20.
The Direct and Indirect Purchaser Plaintiffs argue that insurance coverage is key to biologic infusion products like infliximab because treatment is so expensive that most patients will not be able to pay out of pocket. Id. at ¶ 54. Therefore, infliximab products are either reimbursed by insurance companies, or they are paid for by health care providers who administer the drug through a "buy and bill" system where they pay upfront for the drug then bill an insurer or third-party payor for reimbursement. Id. at ¶ 57. Plaintiffs argue that this system incentivizes providers to choose a biologic that is "widely covered by insurance" to avoid the risk that their reimbursement claim could be denied. Id. at ¶ 58, ¶ 60.
Defendants' Biosimilar Readiness Plan
1. Exclusive agreements
Plaintiffs allege that Defendants' exclusive contracts with insurers block biosimilar *575competition in more than one way. Ind. CAC ¶ 47, 48. Some contracts require insurers to deny coverage for biosimilars altogether. Other contractual preconditions effectively preclude biosimilar competition. For example, the "fail first" exception, under which providers cannot choose a biosimilar unless a patient has first failed to respond to treatment with Remicade. Dir. AC ¶ 23.
2. Bundled rebates
J & J allegedly uses bundled rebates as leverage over insurers by threatening a rebate penalty in "many millions of dollar[s] annually" if insurers do not enter contracts that foreclose them from reimbursing competitor biosimilars. Dir. AC ¶ 76. First, J & J engages in multi-product bundling, linking rebates for Remicade to other J & J drugs and medical devices that their competitors do not offer. Through this "portfolio approach," "insurers and providers that refuse to grant exclusivity to Remicade would be forced to pay higher prices or forego enhanced rebates on multiple J & J products." Id. at ¶ 84.
Second, J & J also bundles demand from "contestable" patients (new users of infliximab or those who have switched to a biosimilar product) and "incontestable" patients (those "already controlling their chronic conditions with Remicade are less likely to switch to a lower-priced biosimilar."). Id. at ¶ 77. J & J's contracts threaten to deny rebates "on allRemicade prescriptions if anyinfliximab biosimilar prescriptions are reimbursed." Id. at ¶ 79. Plaintiffs call this the "rebate trap." Id. at ¶ 80, ¶ 139.
3. Anticompetitive Effects
Pricing data, insurance coverage, and overpayment are among the anticompetitive effects of Defendants' plan. Although Pfizer's Inflectra and Merck's Renflexis entered the market with WAC's (Wholesale Acquisition Cost or list price) at up to a 35% discount to Remicade, Remicade's WAC has increased since Pfizer and Renflexis entered the market in 2016 and 2017. Notably, J & J "still has over a 90% market share." Id. at ¶ 102.
Additionally, Plaintiffs show evidence that "between 2007 and 2017, Remicade's Average Sales Price ("ASP") increased more than 62 percent. Despite Remicade's price hikes, unit sales of Remicade have actually grown 15 percent...from 2012 to 2016." Ind. CAC. ¶ 109. Providers, seeking to avoid rebate penalties, allegedly choose not to stock Inflectra even when it is covered by Medicare and other government programs,
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Joyner, District Judge
Before the Court are Defendants' Johnson & Johnson and Janssen Biotech, Inc. (collectively "Janssen") ("J & J") Motion to Dismiss for failure to state a claim under Fed. R. Civ. P. 12(b)(6) (Doc. No. 67-1), Indirect and Direct Purchaser Plaintiffs' Joint Opposition thereto (Doc. No. 73), and Defendants' Reply in Support thereof (Doc. No. 75).
I. Background
This case arises from an antitrust action brought by Direct and Indirect Purchasers of Defendants' drug Remicade, against Johnson & Johnson, along with its wholly owned subsidiary, Janssen Biotech, Inc. (collectively, "J & J"), alleging artificially inflated prices and monopolization of the pharmaceutical market for biologic infliximab drugs. The Direct and Indirect Purchasers' principle claim is that J & J undertook an anticompetitive scheme, consisting of exclusive agreements and coercive bundled rebates, to foreclose competition posed by biosimilar versions of Remicade, specifically Pfizer's Inflectra and Merck's Renflexis. The scheme allegedly caused providers and insurers to pay overcharges for infliximab products that they would not have paid absent J & J's anticompetitive conduct.
Under consideration is J & J's Motion to Dismiss the Indirect Purchasers' Consolidated Amended Complaint and to Dismiss *574the Amended Direct Purchaser Class Action Complaint for failure to state a claim under Fed. R. Civ. P. 12(b)(6) (Doc. No. 67-1). This Motion is fully briefed and ripe for the Court's adjudication. The Court has considered the parties' submissions and decides this matter without oral argument. Fed. R. Civ. P. 78 ; Loc. R. Civ. P. 7.1(f).
II. Alleged Facts
This case arises from essentially the same facts that have been described in detail in this Court's related decision denying Defendants J & J's motion to dismiss Pfizer's complaint alleging federal antitrust violations. Pfizer Inc. v. Johnson & Johnson,
The medications at the center of this litigation are biologic infliximab products, used as treatment for maintaining chronic auto-immune inflammatory conditions. Dir. AC ¶ 2, ¶ 41. Infliximab products cannot be taken orally and are only administered intravenously, generally by an in-office health care provider. Id. at ¶ 5. J & J's drug Remicade was the first biologic infliximab to enter the market in 1998. Ind. CAC ¶ 21. In 2009, Congress enacted the Biologic Price Competition and Innovation Act (BPCIA), an analog to the shortcut for FDA approval that the Hatch-Waxman amendments provide for chemically synthesized medications. Dir. AC ¶ 8-9. To attain approval as a "biosimilar" under the BPCIA, a manufacturer must demonstrate that "there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency." Ind. CAC ¶ 38. Once J & J's patent on Remicade expired in 2016, the FDA approved three other medications including Pfizer's Inflectra and Merck's Renflexis. Dir. AC ¶ 16-19, Ind. CAC ¶ 4. Competition from the introduction of biosimilars into the infliximab market was expected to lower prices for potentially lifesaving biologic medications that otherwise might have been unaffordable for some patients.2 Dir. AC ¶ 14, ¶ 20.
The Direct and Indirect Purchaser Plaintiffs argue that insurance coverage is key to biologic infusion products like infliximab because treatment is so expensive that most patients will not be able to pay out of pocket. Id. at ¶ 54. Therefore, infliximab products are either reimbursed by insurance companies, or they are paid for by health care providers who administer the drug through a "buy and bill" system where they pay upfront for the drug then bill an insurer or third-party payor for reimbursement. Id. at ¶ 57. Plaintiffs argue that this system incentivizes providers to choose a biologic that is "widely covered by insurance" to avoid the risk that their reimbursement claim could be denied. Id. at ¶ 58, ¶ 60.
Defendants' Biosimilar Readiness Plan
1. Exclusive agreements
Plaintiffs allege that Defendants' exclusive contracts with insurers block biosimilar *575competition in more than one way. Ind. CAC ¶ 47, 48. Some contracts require insurers to deny coverage for biosimilars altogether. Other contractual preconditions effectively preclude biosimilar competition. For example, the "fail first" exception, under which providers cannot choose a biosimilar unless a patient has first failed to respond to treatment with Remicade. Dir. AC ¶ 23.
2. Bundled rebates
J & J allegedly uses bundled rebates as leverage over insurers by threatening a rebate penalty in "many millions of dollar[s] annually" if insurers do not enter contracts that foreclose them from reimbursing competitor biosimilars. Dir. AC ¶ 76. First, J & J engages in multi-product bundling, linking rebates for Remicade to other J & J drugs and medical devices that their competitors do not offer. Through this "portfolio approach," "insurers and providers that refuse to grant exclusivity to Remicade would be forced to pay higher prices or forego enhanced rebates on multiple J & J products." Id. at ¶ 84.
Second, J & J also bundles demand from "contestable" patients (new users of infliximab or those who have switched to a biosimilar product) and "incontestable" patients (those "already controlling their chronic conditions with Remicade are less likely to switch to a lower-priced biosimilar."). Id. at ¶ 77. J & J's contracts threaten to deny rebates "on allRemicade prescriptions if anyinfliximab biosimilar prescriptions are reimbursed." Id. at ¶ 79. Plaintiffs call this the "rebate trap." Id. at ¶ 80, ¶ 139.
3. Anticompetitive Effects
Pricing data, insurance coverage, and overpayment are among the anticompetitive effects of Defendants' plan. Although Pfizer's Inflectra and Merck's Renflexis entered the market with WAC's (Wholesale Acquisition Cost or list price) at up to a 35% discount to Remicade, Remicade's WAC has increased since Pfizer and Renflexis entered the market in 2016 and 2017. Notably, J & J "still has over a 90% market share." Id. at ¶ 102.
Additionally, Plaintiffs show evidence that "between 2007 and 2017, Remicade's Average Sales Price ("ASP") increased more than 62 percent. Despite Remicade's price hikes, unit sales of Remicade have actually grown 15 percent...from 2012 to 2016." Ind. CAC. ¶ 109. Providers, seeking to avoid rebate penalties, allegedly choose not to stock Inflectra even when it is covered by Medicare and other government programs, id. at ¶ 105, shifting costs to the government, which is "forced to continue reimbursing for Remicade, the more expensive product." Id. Both Direct and Indirect Purchaser Plaintiffs allege they have paid artificially inflated prices that are "substantially greater than the prices they would have paid absent the unlawful conduct alleged." Id. at ¶ 146; Ind. CAC ¶¶ 131-132, 137.
III. Legal Standard
Under Rule 8(a)(2) of the Federal Rules of Civil Procedure, Plaintiffs are required only to plead "a short and plain statement of the claim showing that the pleader is entitled to relief, in order to give the defendant fair notice of what the claim is and the grounds upon which it rests, and ... this standard does not require detailed factual allegations." Phillips v. Cty. of Allegheny,
*576Hartig Drug Co. Inc. v. Senju Pharm. Co.,
The plausibility standard "calls for enough fact to raise a reasonable expectation that discovery will reveal evidence of [the claim]." Twombly,
IV. Discussion
1. Direct and Indirect Purchaser Plaintiffs' Joint Sherman Antitrust Act Claims
Plaintiffs have asserted claims under Section 1 and 2 of the Sherman Act and Section 3 of the Clayton Act.3 Ind. ¶¶ 138-144, ¶¶ 147 -152, ¶ 155, ¶¶ 159 - 162; Dir. AC ¶¶ 182-186, ¶ 174-177. As it applies to J & J's motion to dismiss Plaintiffs' federal antitrust claims, Eisai, Inc. v. Sanofi Aventis U.S., LLC,
J & J attacks Plaintiffs' federal antitrust allegations in two primary ways. First, J & J argues Plaintiffs have failed to sufficiently plead antitrust injury. Second, they argue Plaintiffs have failed to sufficiently plead anticompetitive conduct by Defendants.
A. General Antitrust Injury
"It is only anticompetitive conduct, or 'a competition-reducing aspect or effect of the defendant's behavior,' that antitrust laws seek to curtail." Philadelphia Taxi Ass'n, Inc. v. Uber Techs., Inc.,
"The existence of antitrust injury is not typically resolved through motions to dismiss" but rather "after discovery, either on summary judgment or after trial." Brader v. Allegheny Gen. Hosp.,
"[A plaintiff] need not allege proximate cause or antitrust injury separately for each component of the alleged scheme...[rather] [t]he injuries inflicted by [the defendant's] allegedly anticompetitive activities should, instead, be viewed as a whole.' " In re Gabapentin Patent Litig.,
We find that Direct and Indirect Purchaser Plaintiffs' Amended Complaints sufficiently allege antitrust injury because they show facts that make it plausible that J & J's Biosimilar Readiness Plan "prevent[ed] competition in the relevant product market within the relevant geographic [and pharmaceutical] market." Brader,
J & J's efforts to foreclose Pfizer from the market, as Pfizer has alleged, have led to increased prices for consumers and limited competitive options for end payors, providers, and patients. Pfizer provides detailed allegations regarding J & J's exclusionary terms with many of the nation's largest insurers, the incentive structure that forces end payors and providers into accepting those terms, Pfizer's efforts to compete, including its guarantees that Inflectra would cost less than Remicade, and showed how market participants on many levels are injured from J & J's ability to sell Remicade without having to compete with Inflectra and other biosimilars.
Pfizer Inc. v. Johnson & Johnson and Janssen Biotech, Inc., 17-cv-04180 at 14, Doc. No. 58. Applying the same reasoning here, since Plaintiffs allege antitrust injury based on the same anticompetitive scheme at the heart of Pfizer's complaint, they have sufficiently pled antitrust injury.
B. Anticompetitive Conduct
"Anticompetitive conduct is the hallmark of an antitrust claim. An allegation of anticompetitive conduct is necessary both to: (1) state a claim for attempted monopolization; and (2) aver that *578a private plaintiff has suffered an antitrust injury." Philadelphia Taxi Ass'n, Inc. v. Uber Techs., Inc.,
J & J poses three arguments for why Direct and Indirect Purchaser Plaintiffs fail to sufficiently allege anticompetitive conduct. First, they argue that Plaintiffs "benefitted from" "millions of dollars in rebates" and therefore made a free choice in their own economic interest to purchase or reimburse Remicade. (J & J Mot. at 24). Yet it is the coercive threat of losing these rebates, under J & J's contract terms, that is the basis for Plaintiffs' allegations of anticompetitive conduct.
Plaintiffs argue that regardless of discounts and rebates attached to their purchases of Remicade, as in Castro I, "[it is that] because of [J & J's] anticompetitive behavior which reduced competition, they paid more for the [infliximab products] than they would have absent [J & J's] anticompetitive behavior," Castro v. Sanofi Pasteur Inc., No. 11-cv-7178 (JLL),
We find that Plaintiffs have cleared this hurdle by alleging that J & J's exclusive contracts and rebate bundles make it impossible for competitors like Pfizer's Inflectra to compete. Plaintiffs alleged that Pfizer could never effectively offset J & J's rebates because the rebates are linked to such a wide proportion of the patient market (the incontestable demand for Remicade, comprised of patients unlikely to switch treatment), and also linked, through J & J's rebate bundles, to other J & J products that Pfizer and Merck cannot offer. Dir. AC ¶ 138. Therefore, Plaintiffs have pled facts that make it plausible that the "probable effect" of the Biosimilar Readiness Plan is to "substantially lessen competition."
Compare Philadelphia Taxi Association,
*579In re Hypodermic Prods. Antitrust Litig., MDL No. 1730,
Along the same lines, Defendants argue that Direct Purchaser Plaintiff Rochester is "free to purchase Inflectra and Renflexis whenever it likes, at prices it alleges to be lower than Remicade's." (J & J Mot. at 25). Yet Rochester has alleged that it's decision to purchase Remicade at supracompetitive prices is a response to demand from providers who will not buy biosimilars due to fear that they will not be widely reimbursed as a result of exclusive agreements and rebate penalties faced by insurers.
When Plaintiffs allege Defendants have monopolized a relevant market, the Third Circuit inquires into whether a monopolist's anticompetitive conduct has "deprive[d] customers of the ability to make a meaningful choice [between products]." Eisai,
Here, as in UniStrip, Plaintiffs have "[pled] that .... the exclusivity of the arrangements that [Defendant] has imposed on [purchasers] of its products prevents competitors from entering the market, not price competition," UniStrip,
Third, Defendants attack Plaintiffs' allegations of anticompetitive conduct by arguing that biosimilar manufacturers have failed to compete using multi-product bundles. (Mot. at 28). We addressed this same argument in denying J & J's motion to dismiss Pfizer's claims. Although bundling can be anticompetitive when it "forecloses portions of the market to a potential competitor who does not manufacture an equally diverse group of products and who therefore cannot make a comparable offer," Eisai,
See also LePage's,
In addition to multi-product bundling, Plaintiffs argue that Defendants' bundling *580of demand has anticompetitive effects. Dir. AC ¶ 79. The threat of losing rebates on all Remicade prescriptions (including incontestable demand) is similar to the effect of defendants' anticompetitive conduct in Dentsply, where "the threat to cut off supply ultimately provided customers with no choice but to continue purchasing from the defendants." Eisai,
Here, Plaintiffs allege that Defendants' exclusive agreements pose precisely that kind of threat. First, through "fail first" provisions that function effectively as exclusive agreements (Plaintiffs allege it is highly unlikely a physician would prescribe a biosimilar that has "no clinically meaningful difference" to Remicade once a patient has not responded to treatment with the reference drug). Dir. AC ¶ 73. Second, through the "rebate trap" in which J & J threatens "a financial penalty of withholding rebate payments if insurers reimburse for any infliximab product other than Remicade." Dir. AC ¶ 77. Unlike in Eisai, where plaintiff "customers did not risk penalties ... for terminating the [defendant's program] or violating its terms,"
Assessing anticompetitive conduct, we look to whether Defendants' alleged conduct "as a whole, caused or was likely to cause anticompetitive effects in the relevant market." Eisai at 408. See LePage's,
C. Allegations Supporting Competitors' Efforts to Compete
Last, Defendants argue that Plaintiffs have failed to allege specific facts showing that biosimilar manufacturers were unable to offer competitive prices, rather than simply unwilling to engage in price competition. (J & J Mot. at 12). See J & J Mot. at 33-34 (suggesting that "[t]he fact that Pfizer and Merck's list prices were lower does not establish an actual effort to compete," and arguing that Average Sales Price is not an accurate measure of whether prices paid by purchasers are increasing or decreasing since it factors in rebates and discounts.). Defendants also argue that Remicade's ASP has declined since Plaintiffs' pleadings, invalidating Plaintiffs' allegations of competitive harm. Plaintiffs argue that competitive pricing is not a pleading requirement and that nevertheless they have so alleged. See Direct AC, ¶ 102.
We agree with Plaintiffs that the accuracy of ASP pricing data cannot be resolved on a motion to dismiss. See *581In re Burlington Coat Factory Sec. Litig.,
2. Indirect Purchasers' Additional Arguments
A. Sham Litigation and Walker Process Patent Fraud
Indirect Purchaser Plaintiffs additionally allege that J & J aimed to delay the entry of biosimilars through sham patent litigation and a Citizen's Petition to the FDA. Ind. CAC ¶¶ 100-102, 193-194. Defendants argue they are immune from patent suit where Plaintiffs fail to sufficiently plead that the patent litigation was meritless when filed or that it delayed the entry of competitor biosimilars into the infliximab market. (J & J Mot. at 35).
Under the Noerr-Pennington doctrine, " '[t]hose who petition [the] government for redress are generally immune from antitrust liability.' " Prof'l Real Estate Inv'rs, Inc. v. Columbia Pictures Indus.,
To establish that a lawsuit qualifies as a "sham," and will not be immune from suit under Noerr-Pennington, a two-part test is applied. First, we assess whether the lawsuit is "objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits," and we apply a "probable cause" standard, assessing whether the litigant at the time of filing, has a "reasonable belief that there is a chance that a claim may be held valid upon adjudication."
*582We first ask "whether [J & J] could have perceived 'some likelihood of success' in their case at the time of filing."
Plaintiffs try to imply that if Defendants already had patent protection for an antibody in Remicade, filing a subsequent patent suit for the same antibody makes it plausible that they knew the suit was meritless. Yet, the Third Circuit warned against using the outcome of a patent case as evidence that the defendants knew the litigation was a sham at the time of filing. See In re Wellbutrin XL Antitrust Litig.
In lieu of Noerr-Pennington's test for sham litigation, Plaintiffs argue that under Hanover's"more flexible standard[,] ... appropriate when dealing with a pattern of petitioning," we should apply a "holistic review that may include looking at the defendant's filing success - i.e., win-loss percentage - as circumstantial evidence of the defendants' subjective motivations." Hanover 3201 Realty, LLC v. Vill. Supermarkets, Inc.,
Additionally, Indirect Purchaser Plaintiffs fail to allege that biosimilar competitors were forestalled from entering the infliximab market. See In re Wellbutrin,
*583sham litigation allegation lacks "some reasonable particularity in pleading," In re Neurontin Antitrust Litig., No. 1479,
Defendants also argue that Plaintiffs' allegations are too vague to meet the Supreme Court's Walker Process Equip., Inc. v. Food Mach. & Chem. Corp.,
A plaintiff alleging fraud must "state with particularity the circumstances constituting fraud or mistake. Malice, intent, knowledge, and other conditions of a person's mind may be alleged generally." Fed. R. Civ. P. 9(b). See United States ex rel. Moore & Co., P.A. v. Majestic Blue Fisheries, LLC,
To establish a Walker Process fraud, "a plaintiff must, in part, demonstrate '(1) a false representation or deliberate omission of a fact material to patentability, (2) made with the intent to deceive the patent examiner, (3) on which the examiner justifiably relied in granting the patent, and (4) but for which misrepresentation or deliberate omission the patent would not have been granted.' " In re Lipitor,
Indirect Purchaser Plaintiffs' Walker Process patent fraud allegations lack the requisite specificity to allow us to draw a "reasonable inference" that J & J is liable for Walker Process fraud. As the Third Circuit directed in In re Lipitor, "under Twombly, the question is actually whether the Complaint plausibly alleges [that Defendants materially misrepresented facts to a patent examiner, without which the patent would not have been granted]." ' "
Here, by contrast, Indirect Purchaser Plaintiffs do not plead with specificity the substance of alleged "misleading statements," Ind. CAC ¶ 196, or Janssen's specific "manipulative and deceptive practices" before the PTO, or how specifically Defendants "breached its duty of candor and engaged in inequitable conduct before the Patent Office to obtain its '396 patent.' " Id. ¶¶ 97-98. Furthermore, "[a] finding of inequitable conduct does not, by itself, suffice to support a finding of Walker Process fraud." King Drug Co. of Florence v. Cephalon, Inc., Civ. A. No. 2:06-cv-1797,
*584For the aforesaid reasons, we grant Defendants' motion to dismiss Count VI of Indirect Purchaser Plaintiffs' Consolidated Amended Complaint, alleging Walker Process Fraud.
B. Indirect Purchasers' State and Consumer Protection Antitrust Claims
1. Standing to bring state antitrust claims
Indirect Purchaser Plaintiffs, employee benefit health plans covering and reimbursing health care for "thousands of beneficiaries in states throughout the country" (Opp. at 39), allege that Defendants violated state antitrust statutes in twenty-nine states. Ind. CAC ¶¶ 169-185. Defendants argue that these state antitrust and consumer protection claims should be dismissed because Plaintiffs lack Article III standing to sue under the laws of states where they have not yet paid or reimbursed for Remicade.4 Defendants concede Plaintiffs have standing in Florida, Michigan, New York, and West Virginia, where "plaintiffs either reside or allege that their members purchased Remicade." (J & J Mot. at 32). Plaintiffs argue they do have standing even where they have "not yet identified purchases or reimbursements," because Defendants' alleged anticompetitive scheme "makes it likely [Plaintiffs] will be required to reimburse for purchases at higher prices for fewer choices of drugs in all jurisdictions alleged." (Pls' Opp. at 39).
For Article III standing, a plaintiff must show " '(1) an injury-in-fact, which is an invasion of a legally protected interest that is (a) concrete and particularized, and (b) actual or imminent, not conjectural or hypothetical; (2) a causal connection between the injury and the conduct complained of; and (3) that it must be likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.' " In re Wellbutrin XL Antitrust Litig.,
*585We find Indirect Purchaser Plaintiffs have Article III standing to bring their state law claims. Drawing 'all reasonable inferences in Plaintiffs' favor, Hartig Drug Co. Inc.,
Defendants try to argue that named, as distinct from absent, Indirect Purchaser Plaintiffs have not alleged an injury in fact in states where Remicade has not yet been paid for or reimbursed. This argument, however, cannot overcome the Third Circuit's holding that so long as one named plaintiff has established Article III standing, unidentified members of the class will not block class standing on a motion to dismiss. See In re Horizon Healthcare Servs. Data Breach Litig.,
As in In re Chocolate Confectionary Antitrust Litig. and Ortiz v. Fibreboard Corp.,
2. Plausibility of Alleged State Antitrust Violations
Defendants also argue that Indirect Purchaser Plaintiffs fail to allege sufficient facts to make their state antitrust claims plausible under the requirements of various state laws. Plaintiffs withdraw their claims under the law of the Virgin Islands *586and Rhode Islands' consumer protection statute; therefore, those claims are dismissed with prejudice.
First, Defendants argue that Indirect Purchaser Plaintiffs fail to allege a "significant nexus to the state," as required by state antitrust laws in the District of Columbia, Mississippi, North Carolina, South Dakota, Tennessee, and West Virginia. (J & J Mot. at 46).
District of Columbia:
We find that under Sun Dun, Inc. of Wash. v. Coca-Cola Co.,
Mississippi:
We agree with Plaintiffs that Standard Oil Co. of Ky. v. State,
North Carolina:
Plaintiffs concede that the law is unsettled as to whether indirect purchasers claiming violations of North Carolina antitrust laws are required to allege "a substantial in-state effect on North Carolina trade or commerce," Lawrence v. UMLIC-Five Corp., No. 06 CVS 20643,
South Dakota:
Under In re DRAM Antitrust Litigation,
*587Tennessee:
We find that Indirect Purchaser Plaintiffs have sufficiently alleged a violation of Tennessee's antitrust laws under the rule from Standard Oil Co. v. State,
West Virginia:
We find that Plaintiffs have alleged a sufficient "causal connection," In re Magnesium Oxide Antitrust Litig., No. 10-5943 (DRD),
Second, Defendants argue that Indirect Purchaser Plaintiffs fail to allege requisite concerted activity under the laws of California, Kansas, New York, and Tennessee.5 We find Plaintiffs have sufficiently pled allegations that Defendants "engaged in a vertical price-fixing scheme and attempted and conspired to monopolize the respective markets by coercing major insurers into exclusive agreements." Indir. CAC ¶¶ 51-58. See Dimidowich v. Bell & Howell,
3. Consumer Protection Claims
Defendants move to dismiss Indirect Purchaser Plaintiffs' allegations that J & J violated state consumer protection statutes of Arkansas, California, District of Columbia, Florida, Hawaii, Montana, Nevada, New Hampshire, New Mexico, New York, North Carolina, Rhode Island, Utah, Vermont, and West Virginia. Ind. CAC ¶¶ 225-242.
First, Defendants argue that District of Columbia consumer protection claims can only be asserted by consumers, not indirect *588purchaser plaintiffs. (J & J Mot. at 47).
" '[A valid claim for relief under the [D.C. Consumer Protection Procedures Act,
Additionally, we find Indirect Purchasers are "non-profit" organizations under the CPPA, and therefore may "on behalf of itself or any of its members, ... bring an action seeking relief from the use of a trade practice in violation of a law of the District."
Second, Defendants' argument that Indirect Purchaser Plaintiffs' state consumer protection claims are insufficiently pled under the "substantial nexus" requirement of California, New York and North Carolina fails because Plaintiffs allege that Defendants' exclusionary scheme resulted in Remicade and other infliximab products being sold at artificially inflated prices and caused overcharges in those states. See Cast Iron,
Third, Defendants argue that Indirect Purchaser Plaintiffs fail to state a claim under consumer protection laws of New Mexico, New York, and Utah, which require an unconscionable, unfair or deceptive act.6 Defendants' argument here is essentially that made by defendants in In re Dynamic Random Access Memory Antitrust Litig., that the consumer protection statutes "are not meant to cover, and cannot *589be interpreted to cover, antitrust violations brought by indirect purchasers of goods."
Nevertheless, although we find Plaintiffs' allegations fail to establish "deceptive" conduct (we have dismissed their sham patent litigation and Walker Process patent fraud claims), they have sufficiently alleged "unconscionable" or "unfair" acts under the consumer protection statutes of New Mexico and Utah. See In re Dynamic Random Access Memory Antitrust Litig.,
Here, in contrast to the DRAM plaintiffs' "bare allegation" of deception, Plaintiffs have pled "unconscionable" conduct by alleging Defendants coerced insurers and providers into covering or buying only Remicade, to the exclusion of lower-priced biosimilars, resulting in overcharges to purchasers in, among other states, Utah. Ind. CAC ¶¶ 236 (a), 237 (a), 240 (c) ). See In re Packaged Seafood Prods. Antitrust Litig.,
However, Plaintiffs' New York consumer protection claim (under General Business Law § 349 ) must fail because New York's law requires a plaintiff to "allege both a deceptive act or practice directed toward consumers and that such act or practice resulted in actual injury to a plaintiff." Blue Cross & Blue Shield of N.J., Inc. v. Philip Morris USA Inc.,
Fourth, Defendants argue that Indirect Purchaser Plaintiffs are barred from bringing claims under West Virginia's Consumer Credit and Protection Act because they failed to provide pre-suit written notice under W. Va. Code § 46A-6-101 et seq . The 2015 amendment to the statute added the provision that an action may only be brought once a seller has been given "ten days [from receipt of the notice of violation] in the case a cause of action has already been filed to make a cure offer" (emphasis added). W. Va. Code § 46A-6- 106(c). Plaintiffs argue that the 2015 amendment evidences an intent not to bar actions where a plaintiff has sent notice post-suit so long as notice was eventually sent and provided seller with ten days to make a cure offer. Although "courts have interpreted this statute as a 'mandatory prerequisite[ ]' to commencing a consumer protection claim under the Act," In re Effexor Antitrust Litig., Civil Action No. 3:11-cv-5661 (PGS)(LHG),
*590Here, Plaintiffs sent Defendants notice on May 21, 2018, three months after filing their CAC, an instance contemplated by the amendment, where "a cause of action [had] already been filed". (J & J Reply at 29). In keeping with the West Virginia Legislature's intention that the state's consumer protection laws as amended "not be construed to prohibit acts or practices which are reasonable in relation to the development and preservation of business or which are not injurious to the public interest," W. Va. Code § 46A-6-101 (LexisNexis, Lexis Advance through all 2018 Regular Session Legislation), we find Plaintiffs fulfilled their notice obligation.
Fifth, Defendants argue that Plaintiffs fail to meet the venue requirements8 of Arizona's antitrust and the District of Columbia's consumer protection statutes. We find federal case law persuasive that "[w]hether the state law that provides for the requisite state court jurisdiction is couched in permissive or mandatory terms has never been thought to affect the federal courts' jurisdiction." D.C. ex rel. Am. Combustion, Inc. v. Transamerica Ins. Co.,
Unless Congress has "expressly provide[d] that removal [to federal court] is improper," D.C. ex rel. Am. Combustion, Inc. v. Transamerica Ins. Co.,
V. CONCLUSION
For the foregoing reasons, Indirect Purchaser Plaintiffs' sham litigation and Walker Process claims, as well as their claims under the consumer protection statutes of Rhode Island and New York are dismissed. For all other claims, J & J's Motion to Dismiss is denied.
An appropriate Order will follow.
Related
Cite This Page — Counsel Stack
345 F. Supp. 3d 566, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-remicade-antitrust-litig-paed-2018.