Class Action and Product Insights for Your Business
June 10, 2016 - Drug & Medical Device, Product Liability, Consumer Products

Generalized Products Liability Claims Not Viable Post-Spokeo

The Supreme Court case Spokeo, Inc. v. Robins reaffirmed and clarified the requirements necessary for plaintiffs to establish standing.[1]  As evidenced by the recent First Circuit case Hochendoner v. Genzyme Corp., the analysis set forth in Spokeo is essential to determining the viability of products liability claims.[2]  There, the two consolidated class action lawsuits involved products liability allegations against a drug manufacturer.  But because plaintiffs did not allege sufficiently specific harm, the First Circuit affirmed dismissal of the case on grounds of Article III standing.[3]


The plaintiffs and putative class members in Hochendoner all have Fabry disease, a rare genetic disorder that prevents the body from properly breaking down fats.  Fabry disease can lead to gastrointestinal issues, stroke, and heart and kidney failure.  Although there is no cure for Fabry, it can be effectively treated with Fabrazyme, the only FDA-approved enzyme replacement therapy for the disease.  Defendant Genzyme Corporation is the exclusive licensee of the Fabrazyme patent and is the only producer of Fabrazyme.  Various problems with Genzyme’s manufacturing facilities led to a shortage of Fabrazyme beginning in 2009.  Genzyme initiated a rationing plan and was unable to fully restore supplies of Fabrazyme until 2012.

The plaintiffs in Hochendoner alleged several causes of action connected to the Fabrazyme shortage, including statutory violations, torts, breaches of warranty, breaches of contract, and losses of consortium.  Plaintiffs challenged the dismissal of two categories of claims on appeal: (1) plaintiffs’ claim that patients experienced an accelerated course of deterioration on the lower dose of Fabrazyme; and (2) plaintiffs’ claim that they experienced harm attributable to tainted Fabrazyme.  Although Genzyme challenged plaintiffs’ standing for the first time on appeal, the First Circuit noted that standing arguments may be raised at any stage of litigation.

Standing Analysis

Citing Spokeo, the court recognized the Supreme Court’s recent articulation of Article III standing as having two distinct requirements:  concreteness and particularization.  While concreteness focuses on whether an injury actually exists, the particularization requirement ensures that a plaintiff has been personally affected by the injurious conduct.  Plaintiffs did not link the alleged injuries to any specific plaintiff, thus failing to satisfy the particularization requirement.  The complaints simply listed each plaintiff’s name and place of residence and alleged that each plaintiff had Fabry disease and had a history of taking Fabrazyme.  However, the complaints did not allege any specific information regarding the harm that was inflicted on each individual plaintiff.  With the exception of one named plaintiff, the court concluded that none of the plaintiffs had standing to assert claims based on their theories of injury because they failed “to plausibly allege that he or she suffered an injury in fact as a result of accelerated disease progression or receipt of a contaminated drug.”

Future Implications

This case is indicative of the implications that Spokeo will have on all cases, including those involving products liability claims.  The Court in Spokeo emphasized that plaintiffs must allege an injury that is both concrete and particular.  The particularization requirement will likely continue to be especially important in class actions asserting allegations against drug manufacturers.  Hochendoner set an important precedent in requiring plaintiffs to link alleged injuries to specific plaintiffs and to allege much more than generalized harms.


[1] Spokeo, Inc. v. Robins, No. 13-1339, slip op. (U.S. May 16, 2016).  The claims in Spokeo were related to statutory violations, but courts have found Spokeo to apply in a variety of cases.

[2] Hochendoner v. Genzyme Corp., Nos. 15–1446, 15–1447, 2016 WL 2962148 (1st Cir. May 23, 2016).

[3] The district court had dismissed the case not for lack of standing, but for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).