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In Re: Avandia Marketing, Sales Practices and 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 concealment resulted in Plaintiff and others purchasing Avandia instead of seeking alternative treatments. *fn2 Plaintiff alleges that he is a resident of Florida 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. Florida Deceptive and Unfair Trade Practices Act

In his first claim for relief, Plaintiff alleges violations of the Florida Deceptive and Unfair Trade Practices Act *fn11 seeking both refunds and medical monitoring. To state a claim under the statute, the complaint must not only plead that the conduct complained of was unfair and deceptive, but also that the complaining party was aggrieved by the alleged act. *fn12 Plaintiff here has not done so; although Plaintiff has made exhaustive allegations regarding GSK's alleged unfair or deceptive practices, the complaint fails to identify any specific advertisements or other materials that Plaintiff viewed, how he was misled by GSK's alleged misrepresentations or how these misrepresentations caused any injury. *fn13 The complaint also fails to allege that the prescribing physician received any misrepresentation of fact that was relied upon in prescribing Avandia. *fn14 All of these are facts that should be within Plaintiff's knowledge, and therefore the failure to allege them cannot be excused. *fn15

B. Medical Monitoring

On behalf of the proposed Florida Medical Monitoring Class, Plaintiff alleges that "[a]s a direct and proximate result of Defendant's misrepresentations regarding Avandia's safety, Plaintiff and the Florida Medical Monitoring Class have an increased risk of contracting a serious latent disease and will incur (if they have not incurred already) the cost of medical monitoring." *fn16

To state a claim for medical monitoring under Florida law, the plaintiff must allege:

(1) exposure greater than normal background levels;

(2) to a proven hazardous substance;

(3) caused by the defendant's negligence;

(4) as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease;

(5) a monitoring procedure exists that makes the early detection of the disease possible;

(6) the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and

(7) the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles. *fn17

Defendant argues that Plaintiff has not alleged the existence of a traditional tort cause of action, such as negligence, and that Plaintiff has not alleged the need for cardiovascular monitoring for Avandia patients beyond that recommended for all patients with Type 2 diabetes. The complaint is grounded in allegations of fraud, not negligence, and the claim for medical monitoring essentially tracks the elements of the claim, but without any specific facts alleged (e.g., as to what medical monitoring procedure exists and how it differs from the monitoring for all patients with Type 2 diabetes). *fn18 Because Plaintiff has not alleged specific facts in support of the claim of negligence, nor the specific monitoring sought, the claim will be dismissed.

C. Unjust Enrichment

Unjust enrichment is an equitable doctrine that applies where (1) the plaintiff conferred a benefit on the defendant, who had knowledge of the benefit; (2) the defendant voluntarily accepted and retained the benefit; and (3) under the circumstances, it would be inequitable for the defendant to retain the benefit without paying for it. *fn19 Where, as here, the plaintiff "relies on a wrong to supply the unjust factor," *fn20 the right of the recovery arises from the alleged tort, which if proven, might entitle him to damages, not unjust enrichment. *fn21

Plaintiff alleges that he was prescribed Avandia for the treatment of his diabetes and he received the product for which he paid. Plaintiff has not alleged that Avandia did not serve its intended purpose of reducing blood-sugar levels. The allegations that Avandia was not safe, and that GSK knew it was unsafe but promoted the drug anyway, do not give rise to a claim for unjust enrichment. *fn22


Plaintiff's complaint fails to state any claim upon which relief can be granted. Defendant's motion to dismiss will be granted without prejudice; Plaintiff may file an amended complaint.

An appropriate order will be entered.

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