[Drug and Device Law] A "Too Old" OTC Product Does Not A Class Action Make

This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy.   We volunteered to photograph the event, because the usual photographer was not able to attend.   And so, we didn’t run – something we used to do, if the definition is expanded to include a shuffle befitting Tim Conway’s character on The Carol Burnett Show.  Instead, we stood at the start line, snapping pictures and gazing longingly at the runners disappearing down the path.  Observing our misty countenance, a friend asked us why we didn’t start running again if we missed it so much.  In wordless response, we produced our yellowed and crumbling birth certificate.  To which our friend replied, “’Too old’ is a meaningless phrase – you will have to do better than that.”

That is exactly what the Court of Appeal of Louisiana said to the plaintiff in Jean Cooper vs. CVS Caremark Corporation, et al., 2015 La. App. LEXIS 1201 (La. App. 1 Cir. June 17, 2015).  Plaintiff purchased an over-the-counter allergy remedy at a CVS store.  Before she used any of the medication, she noticed that the expiration date on the package had passed.  She “did not request a refund, could not remember if she complained to the store, did not take any of the medicine, and, by her own admission, did not suffer any damages as a result of the purchase.”  Cooper, 2015 La. App. LEXIS 1201 at *1-2.  
We know what you’re thinking:  “This is the heady stuff of a class action lawsuit.”  Plaintiff had the same thought.  She sued several CVS entities, alleging that they “had a long history of selling out of date medications” and that the expired allergy remedy “had exposed her to health risks.”  Id. at *2 (internal punctuation omitted).  Plaintiff requested an award of damages, as well as “injunctive relief to remedy violations of law,” and an order requiring CVS, inter alia, to stop selling expired products and to notify purchasers of “the true characteristics of the products sold.”  Id.   Plaintiff sought certification of the suit as a class action and requested that she be confirmed as class representative. 
CVS moved for summary judgment, arguing: 1) Plaintiff lacked standing to pursue injunctive relief and could not prove the requisite “irreparable injury;” and 2) Plaintiff admitted in deposition that she had no damages and did not tender the product for refund or replacement.  Plaintiff countered with an argument that she was not required to prove irreparable harm to be entitled to injunctive relief, because the sale of the expired medication violated 21 U.S.C.A. Section 331, of the FDCA, which prohibits introduction or delivery of an “adulterated drug” into interstate commerce.   Id. at *4.  In support of her argument, plaintiff cited a 1995 FDA guidance document, providing, “We regard expired drug products to be adulterated within the meaning of [the Current Good Manufacturing Practice (”CGMP”) statute],” but concluded that “it would not be appropriate to cite a retailer for deviation from the CGMP . . . regulations, because [the] regulations apply to drug product manufacturers.  Id. at *5-6 (emphasis in original).   Plaintiff also introduced the affidavit of an individual who “visited 63 CVS stores and confirmed that expired product were purchased and/or documented at those stores . . . .”  Id. at *6.
The trial court granted summary judgment for CVS on all of plaintiff’s claims, noting that the FDA guidance document plaintiff cited was “not appropriate summary judgment proof and was unpersuasive,” and that plaintiff “failed to establish irreparable harm or that the cited provisions of the FDCA established a prohibitory law that supported the claim for injunctive relief.”  The Court also found no factual support for plaintiff’s damages claim, but recognized that plaintiff had testified in deposition that she was not seeking damages. Id. at *6-7. 
On appeal, plaintiff argued that 1) the FDCA prohibits the sale of expired products; thus, a “prohibitory law” supported her claim for injunctive relief; and 2) her “shopping survey” demonstrated “irreparable injury,” because CVS was continuing to sell expired products.”
The appeals court was about as patient with plaintiff’s nonsense as we feel reading it.  First, the Court noted that the FDCA language plaintiff cited did not support the interpretation she proposed.   Specifically, there was no language supporting plaintiff’s argument that CGMP statutes and regulations should be construed to regulate the retail sale of OTC products, and the guidance document on which plaintiff relied was “not binding on the public or the FDA and it [did] not establish legally enforceable rights or responsibilities.”  Id. at*10.  Even if it did, it would not have supported plaintiff’s position on its merits, as it “also states that retailers should not be cited for deviations” from CGMPs.  Id.  As to plaintiff’s alternate argument – that she did suffer irreparable injury because she “was duped into buying unreliable expired medicine” – the Court similarly rolled its eyes, emphasizing that “[i]rreparable injury is a loss that cannot be adequately compensated in money damages . . . ,” id. at *12,   while, in this case, plaintiff “presented no evidence of any physical, mental or emotional injury.” Id. at *13.  Rather, “the only potential loss identifiable from the record is the purchase price [plaintiff] paid for the expired medication; however, that loss is compensable in money damages.”   The Court concluded, “The record contains no evidence of a violation of a prohibitory law or proof of irreparable injury to [plaintiff] or any other purported member of the putative class.  The trial court did not err in granting summary judgment and dismissing Cooper’s claims, both individually and on behalf of the putative class.”  Id. at *15.
Our jobs would be a lot less fun if plaintiffs’ lawyers only filed meritorious claims.  But it makes our Monday to read a case in which plaintiff had no injury, no damages, and no cause of action, and in which the Court succinctly found just that.   Yeah, the drug was “too old,” but that didn’t open the doors to a lawsuit.  Just take it back for an exchange or a refund.  As for our defunct running career, we’ll mull it over. 


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Posted By Rachel B. Weil to Drug and Device Law at 6/29/2015 02:16:00 PM

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