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In Re: Avandia Marketing, Sales Practices and Products Liability Litigation v. Smithkline Beecham Corporation D/B/A Glaxosmithkline

September 7, 2011


The opinion of the court was delivered by: Hon. Cynthia M. Rufe




Rufe, J.

The plaintiff in this case is a former user of the prescription diabetes drug Avandia. Plaintiff does not allege that he has been physically injured as a result of taking Avandia; instead he seeks a refund of any monies he paid for Avandia (including insurance co-pays) and medical monitoring. Each type of relief is sought on behalf of a class of similarly-situated individuals (the "Refund Class" and the "Monitoring Class," respectively), but no classes have been certified. The defendant, GlaxoSmithKline LLC ("GSK"), has filed a motion to dismiss. The motion will be granted.


Plaintiff alleges that GSK promoted the use of Avandia to lower blood-sugar levels of patients with Type 2 diabetes. Plaintiff also alleges that taking Avandia significantly increases the patient's chances of suffering a heart attack or susceptibility to other health risks, and that GSK concealed the risks of Avandia use while promoting the drug's safety, efficacy, and effectiveness through a fraudulent and deceptive marketing program. *fn1 According to Plaintiff, this resulted in Plaintiff and others purchasing Avandia instead of seeking alternative treatments. *fn2

Plaintiff alleges that he is a resident of New Jersey and that on or after May 25, 1999, he was prescribed Avandia for the treatment of Type 2 diabetes, that he purchased the drug and was "exposed" to Avandia for at least 12 weeks, *fn3 and having been exposed, he is at high risk for future myocardial ischemic events. *fn4 These are the only allegations in the complaint specific to Plaintiff.


Dismissal of a complaint under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief can be granted is appropriate where a plaintiff's "plain statement" does not possess enough substance to show that plaintiff is entitled to relief. *fn5 In determining whether a motion to dismiss is appropriate the court must consider those facts alleged in the complaint, accepting the allegations as true and drawing all logical inferences in favor of the non-moving party. *fn6 Courts are not bound to accept as true legal conclusions couched as factual allegations. *fn7 Something more than a mere possibility of a claim must be alleged; the plaintiff must allege "enough facts to state a claim for relief that is plausible on its face." *fn8 The complaint must set forth direct or inferential allegations with regard to all the material elements necessary to sustain recovery under some viable legal theory. *fn9 The court has no duty to "conjure up unpleaded facts that might turn a frivolous action . . . into a substantial one." *fn10


A. New Jersey Consumer Fraud Act The complaint alleges a claim on behalf of the proposed Refund and Medical Monitoring Classes for violations of the New Jersey Consumer Fraud Act ("NJCFA"). *fn11 To state a claim under the NJCFA, a plaintiff must allege unlawful conduct, an ascertainable loss, and that the loss was caused by the unlawful conduct. *fn12 The plaintiff is not required to allege reliance or malicious intent, but the loss must be actual, not hypothetical, and cannot be based on a fraud-on-the-market theory. *fn13 Plaintiff alleges that Avandia is more expensive than one alternative treatment, insulin, but does not allege that he would have been treated with insulin; nor does the complaint allege that other drugs Plaintiff identifies as alternatives to Avandia, such as Actos, are less expensive, or that his physician would have prescribed a less-expensive treatment regimen. "Due to the discretion of the prescribing physician, the injury alleged is entirely hypothetical, and cannot provide the basis for a claim under the NJCFA."*fn14

Plaintiff's claim under the NJCFA on behalf of the proposed Medical Monitoring Class has been rejected by the New Jersey Supreme Court, which held in a similar case involving the drug Vioxx that: plaintiffs do not allege a personal physical injury. Thus, we conclude that because plaintiffs cannot satisfy the definition of harm to state a product liability claim under the [Product Liability Act ("PLA")], plaintiffs' claim for medical monitoring damages must fail. Plaintiffs' effort to expand the definition of harm to include medical monitoring is best directed to the Legislature.

Plaintiffs also seek to avoid the requirements of the PLA by asserting their claims as CFA claims. However, the Legislature expressly provided in the PLA that claims for "harm caused by a product" are governed by the PLA "irrespective of the theory underlying the claim." N.J.S.A. 2A:58C-1(b)(3). We explained in [another case], that "[t]he language chosen by the Legislature in enacting the PLA is both expansive and inclusive, encompassing virtually all possible causes of action in relating to harms caused by consumer and other products." As a result, we declared that "[i]n light of the clear intention of our Legislature to include all [product liability] claims within the scope of the PLA, we find no ground on which to conclude ...

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