Opinion ID: 799929
Heading Depth: 3
Heading Rank: 2

Heading: Montgomery

Text: Montgomery, a consumer of Rebetol and PEG-Intron, brought the MAC on behalf of a putative nationwide class of consumers of the Subject Drugs. The MAC alleges facts particular to her experience and use of two of the Subject Drugs, as well as the various legal theories pursued on behalf of the consumer plaintiffs. Montgomery suffered from Hepatitis C, a viral liver infection, and after tests conducted in 1999 showed that she was asymptomatic, her physician, Dr. Jeffrey R. Willis, decided not to prescribe her a combination therapy of Rebetol and Intron-A. At a follow-up visit in September 2001, Dr. Willis recommended a different treatment plan, [6] even though Montgomery was still asymptomatic. A few months after this consultation, Dr. Willis prescribed Montgomery the PEG-Intron and Rebetol combination therapy, also called the PEG-Intron Combination Therapy. (MAC ¶ 75.) The MAC avers that at the time she was prescribed the Subject Drugs, they were only approved for patients with compensated liver disease, and that since she was healthy and did not need treatment, she suffered from the serious side effects of the drugs and lost weeks of work due to these side effects. The MAC further claims that Dr. Willis changed his mind about her treatment plan because of Schering's improper marketing of the Rebetol/PEG-Intron combination therapy. Specifically, it alleges: Dr. Willis' new plan for Mrs. Montgomery's treatment for her asymptomatic Hepatitis C evidences that he was subjected to the marketing and sales scheme by Schering alleged in this Amended Complaint. (MAC 130.) The MAC reaches this conclusion based on the alleged facts that: (1) due to Schering's off-label marketing techniques, Dr. Willis mistakenly believed that the combination therapy was the standard treatment for Montgomery's condition; (2) Dr. Willis prescribed the combination therapy before sending Montgomery for two tests that he suggested were necessary before beginning the treatment; (3) Dr. Willis received misinformation from a nurse on his staff who was believed to be a Schering-paid nurse. The MAC contains extensive factual allegations regarding the types of improper marketing techniques that Schering used, which Montgomery alleges must have influenced Dr. Willis between 1999, when he declined to prescribe her the drugs, and 2001, when he changed his treatment plan. The MAC reasserts many of the same allegations about Schering's techniques alleged in the TPP Complaint. The MAC also incorporates by reference all of the factual allegations made in a Qui Tam action brought against Schering in the District of Massachusetts, and the allegations in the Criminal Information, discussed above, to which Schering pleaded guilty. (MAC ¶¶ 99-101.) The allegations include claims about Schering's scheme for providing kickbacks to doctors for prescribing the drugs, false promotional claims made by sales representatives, and the placement of a Schering-paid nurse on Dr. Willis' staff. The MAC further alleges that Montgomery would not have been prescribed and would not have paid for such a costly, noxious, and dangerous medication cocktail had she known all the facts that were concealed by Defendants and her doctors.... (MAC ¶¶ 4, 5.) The Defendants moved to dismiss the MAC under Rule 12(b)(1). The District Court dismissed the MAC for lack of jurisdiction under Rule 12(b)(1), finding that it failed to establish a sufficient nexus between her alleged injury and Schering's alleged misconduct. In reaching this conclusion, the Court first found that Montgomery had alleged an adequate injury-in-fact for her claims under the Washington Consumer Protection Act and various common law theories. The District Court held, however, that her standing to bring suit founders on her inability to establish any nexus between her purported injurybe it the needless purchase of the Rebetol/PEG-Intron, the side-effects she claims to have suffered and/or the lost work timeand the wrongful conduct in which Schering was allegedly engaged. (A. 117.) Montgomery's theory that the Defendants injured her is premised on whether Dr. Willis shifted his opinion about the appropriate treatment plan due to Schering's marketing practices. The District Court found that the MAC fails to provide any factual allegations that would support [this] conclusion. (A. 118.) On appeal, Montgomery challenges the Court's dismissal of the MAC on several grounds. She argues that the Court improperly failed to consider certain factual allegations, some of which she claims establish the necessary causal link. Moreover, with respect to the factual allegations that the Court did consider, Montgomery argues that it applied an improper standard in rejecting those allegations as inadequate, and claims that when reviewed under the proper standard, they do adequately allege a causal nexus. Montgomery first challenges the District Court's decision on the ground that it erred in not fully considering the entirety of the record and taking all factual allegations as true. Montgomery notes that the MAC incorporates several other documents that set forth in great detailbeyond the extraordinary detail contained in the complaint itselfthe nature and extent of Schering's alleged unfair deceptive acts and practices. (Montgomery Br. at 25.) These documents include: (1) factual averments based on the personal knowledge of three former Schering employees in their related qui tam case filed in the District of Massachusetts (incorporated in the MAC at ¶ 105); (2) factual allegations about the Subject Drugs detailed in the related TPP Amended Complaint (incorporated in the MAC at n. 1, A. 987); (3) the Criminal Information to which Schering pleaded guilty (incorporated in the MAC at ¶ 101); (4) the factual averments in the Settlement Agreement in the criminal case (incorporated in the MAC at ¶ 102); and (5) the Corporate Integrity Agreement and addendum to the same in the criminal case (incorporated in the MAC at ¶ 103). (Montgomery Br. at 25-26.) Montgomery asserts that it is not clear from the district court's opinion that it took proper account of these documents, and the substantial facts contained therein, in its ruling. ( Id. at 26.) In regard to these documents, the District Court stated: Plaintiff apparently believes that somehow, through the incorporation of allegations made in other proceedings, such as the False Claims Act action filed by three qui tam relators, she can pursue her own relief against Schering. The irreducible minimum of Article III standing, however, requires Montgomery to demonstrate that she, personally, has suffered a concrete injury, that her injury can be traced to Schering's misconduct and that it is capable of redress by the Court. (A. 120.) This statement suggests that the District Court did not permit Montgomery to rely on factual allegations that pertain to the standing of other parties in order to establish her own standing. The Court also stated that it did not ignore those documents: Assuming Schering engaged in all of the marketing practices detailed in [the MAC] and in documents incorporated by reference, and assuming that the practices might be deemed unlawful, none of the factual allegations she makes establish the required nexus between her injury and Schering's actions. (A. 120-21.) It is thus clear that the District Court did not ignore the documents that Montgomery sought to incorporate by reference in her Amended Complaint. It is also clear that the District Court properly concluded that the averments of misconduct did not support a non-conjectural conclusion that Dr. Willis had been induced by such misconduct to order the PEG-Intron Combination Therapy. Moreover, as a general matter, even if the Court did decline to consider some of these documents, this was not necessarily an error. Under Fed.R.Civ.P. 8(a)(2), a complaint should set forth a short and plain statement of the claim to relief. Plaintiffs cannot be permitted to incorporate an endless series of external documents into a complaint simply by reference to them, as this would lead to an impossible task for defendants in filing their answers, and for courts in reviewing the sufficiency of complaints. In any event, to the extent that Montgomery specifically claims that this alleged failure to consider particular allegations in the incorporated documents has prejudiced herthat is, that such allegations would have cured any of the deficiencies in stating causationwe discuss those arguments infra. To establish standing, the MAC sought to allege a causal nexus between Dr. Willis' decision to prescribe the drugs to Montgomery, and the Defendants' alleged fraudulent marketing and bribery schemes. The District Court held that the MAC failed to adequately allege any connection between Schering's alleged bribery scheme and Montgomery's experience. The Court explained that the MAC lacks any allegation either directly accusing or even plausibly suggesting that ... Dr. Willis received [illegal] remunerations. (A. 120.) The Court also rejected the MAC's allegation about Dr. Willis's involvement in a clinical trial: In the case of Mrs. Montgomery and other asymptomatic Hepatitis C patients at [Dr. Willis' practice], upon information and belief based upon the evidence of record, it is alleged that Defendants engaged Dr. Willis in a phony clinical trial respecting Rebetron Combination Therapy beginning shortly after the August 2001 FDA approval letter issued. (MAC ¶ 93.) The Court found this allegation inadequate because it was conclusory. (A. 120.) Even assum[ing] the truth of fact asserted, and credit[ing] the allegation that Dr. Willis was involved in a clinical trial, the Court refused to credit the bald assertion that the trial was `phony,' presumably meaning that Dr. Willis was not actually gathering data and studying patients... but [was only a] subterfuge for collecting payments from Schering for prescribing the drugs being studied. (A. 120.) It rejected this assertion because [n]othing in the [MAC] supports this characterization. (A. 120.) On appeal, Montgomery argues that the Court wrongly refused to accept this allegation as true. In our view, even if we found these arguments to be meritorious, they are still unavailing. Even if we accepted the MAC's allegation that Dr. Willis was involved in a phony clinical trial for Rebetron Combination Therapy, this fact does not establish the necessary causal connection between Schering's misconduct and Montgomery's injury, because she was not prescribed the Rebetron Combination Therapy. To the contrary, she was prescribed the PEG-Intron Combination Therapy, a combination of Rebetol and another longer-lasting form of interferon, PEG-Intron. ( See MAC ¶¶ 23, 64-66, 74.) Thus, as Schering observes: Dr. Willis's thoughts or clinical experiences with that drug therapy are of no moment here. (Schering Br. at 26.) Notably, Montgomery does not apparently challenge this contention in her Reply Brief. In our view, the fact that the allegedly phony trial did not even concern a treatment regimen that her doctor prescribed to her is dispositive. There is no allegation of fact that supports a connection between Schering's unlawful conduct of involving Dr. Willis in a phony trial, and Montgomery's prescription for a different drug therapy. Montgomery's other arguments are equally unpersuasive. She contends that the Court unfairly rebuke[d] [her] for not `directly accusing her doctor of a crime i.e., engaging in a phony clinical trialand defrauding his patients and the government. (Montgomery Br. at 27.) She also invokes Rule 11 to argue that her lawyers were not permitted to make such an allegation about Dr. Willis at this time. ( Id. at 28.) She continues: [t]he fundamental problem with the district court's dismissal is that the court required some direct accusation of criminal conduct by a non-party at the pleading stage. It was wrong to do so. ( Id. ) This argument misconstrues the District Court's analysis, which did not require the MAC to charge Dr. Willis with a crime. Rather, the Court considered the allegation that the trial was phony to be conclusory because there was simply no other allegation in the MAC to support the assertion that this particular trial was in fact a disguised bribery scheme. To satisfy the standard, the MAC would not have to allege that Dr. Willis had committed a crime, but state factual allegations suggesting that the clinical trial was in fact somehow fraudulent or undertaken in bad faith. Montgomery argues that the MAC contains allegations that support the claim that the trial was phony, including an allegation citing to a memorandum from one of the qui tam relators, a Schering employee who stated that his job is secure in part because he had over 50 [Hepatitis] trials underway. (Montgomery Br. at 30, citing MAC ¶ 94-95.) This general assertion that 50 Hepatitis clinical trials were underway, however, does not support the conclusion that Dr. Willis's trial was one of those phony trials. These allegations therefore do not bolster the main allegation that Dr. Willis was involved in a phony clinical trial. ( Id. at 30.) Montgomery points to no other factual allegations in the MAC that support the conclusion that Dr. Willis was in any way connected with phony trials. The allegation therefore does appear to be a speculative conclusion that falls short of stating facts that raise a plausible right to relief. We conclude that the Court did not err in rejecting the assertion, without other supporting factual claims, that Dr. Willis was involved in a phony clinical trial. See Morse v. Lower Merion Sch. Dist., 132 F.3d 902, 906 (3d Cir.1997) (holding that a court reviewing a complaint need not credit bald assertions or legal conclusions). The MAC also claimed that three other Schering-sponsored programs associated with Montgomery's treatment under Dr. Willis were the causal link between his prescription and Schering's false marketing campaign. First, the MAC alleges that a Schering-paid nurse in Dr. Willis' office, identified in the MAC as D.S. or Diana S., was part of the marketing scheme that affected her treatment. (MAC ¶ 42-25.) The Court held that this allegation that Diana S. was part of Schering's deceitful marketing scheme and somehow caused Dr. Willis to prescribe Rebetol/PEG-Intron to Montgomery is purely conclusory. (A. 119.) The Court reasoned that, at most, it could accept as true the alleged facts, which stated that this nurse was paid by Schering to provide patient support in matters concerning injection-training and side effects; however, the Court concluded, there is no indication that Schering executed the alleged misrepresentations or kickbacks through this PCC. (A. 119.) The MAC makes numerous allegations about Diana S. based on information and belief; it never explains, however, the basis for its conclusion that she was in fact employed by Schering, or that she disseminated any false information to Dr. Willis about the Subject Drugs. In our view, the MAC fails to allege sufficient facts to show that her treatment plan was influenced by Diana S. at the behest of Schering. The District Court also discredited the MAC's allegations with respect to two other Schering-sponsored programs, the Access Assurance Program and Be in Charge Program. According to the MAC, the Access Assurance Program supported patients who were undergoing treatments by the Subject Drugs by ensuring they had a consistent supply of the product, and also allegedly to serve as a marketing technique. (MAC ¶ 48-51.) Similarly, the Be in Charge program was designed to help support patients on Rebetron therapy by providing them with a nurse to ensure such patients were `compliant' with the therapy program, so that Schering could ensure that [it] sold as much Rebetron Combination Therapy as possible. (MAC ¶ 52.) However, the MAC provides no factual allegations describing how either of these programs interfered with Dr. Willis' decision to prescribe Montgomery the Subject Drugs through any false information, or that it gave her any false claims about the drugs that otherwise injured her. Accordingly, we conclude that these allegations are not sufficient to form the necessary causal nexus. Montgomery also raises a handful of other claims that are ultimately unavailing. She argues that the MAC properly pleaded causes of action for statutory consumer fraud, common law conspiracy, aiding and abetting and unjust enrichment. (Montgomery Br. at 45.) Montgomery argues that the Court should have evaluated her standing to bring the claims with regard to each particular claim, and notes that other than a brief discussion of the Washington Consumer Protection Act, the Court's opinion contains no discussion of the elements of the plaintiff's four claims, or the sufficiency of her allegations of the same in the MAC. ( Id. at 46.) She requests that we vacate the decision and remand it for failure to adequately address the first step of the requisite two-step process under Rule 12. ( Id., quoting Fowler, 578 F.3d at 210 (First, the factual and legal elements of a claim should be separated.)). Montgomery then proceeds to exhaustively discuss how the MAC pleads all of the requisite elements of each of her claims. Montgomery's focus on the pleading standards for each of her claims is secondary to the threshold issue that the Court addressed when determining that the MAC did not adequately allege an injury fairly traceable to Schering's alleged misconduct. Although the MAC is replete with factual allegations and indeed asserts them with greater specificity than the TPP Complaint, they do not present a plausible allegation actually linking Montgomery's injuries to any type of miscommunication or false claim about the drugs that were actually prescribed to her. Accordingly, we will affirm the Court's conclusion that the MAC failed to adequately allege causation.