The Mass Tort Defense Blog reported recently that the North Carolina federal district court overseeing the MDL concerning panacryl sutures declined last week to certify a proposed national class action in In re Panacryl Sutures Products Liability Cases, 2009 WL 3874347 (E.D.N.C. 11/13/09). The decision is a significant one for pharmaceutical and medical device MDL practitioners because the court's reasoning in denying class certification is broadly applicable to other medical device products. It is increasingly rare for plaintiffs to obtain class certification in medical device litigation and this case is no exception. Panacryl Sutures are synthetic, braided, absorbable surgical sutures, designed to remain in a patient's body for 24-36 months after surgery to provide wound support. Various plaintiffs alleged that Panacryl Sutures were defective in that they allegedly caused a high rate of foreign body reactions when used as directed. Plaintiffs further alleged that the defendants failed to provide adequate warning of the dangers associated with the devices. Plaintiffs eventually filed a motion to certify a National Class Action. The Panacryl sutures were the subject of a 2006 recall by FDA.
In his blog post, Dechert's Sean P Wajert, discusses the various rationale underlying the court's decision not to certify a national class. In evaluating the requirements under Rule 23(a) and Rule 23(b), the court considered the impact that the laws of the various states where plaintiffs reside would have on the proposed class. Considering Rule 23(a)(3)'s "typicality" requirement, the court found that the plaintiffs had not considered the varying substantive laws governing every class member. Considering to Rule 23(b), the court found that in class actions governed by the laws of several states, variations in state law often overwhelmed common issues. The court held that the plaintiffs would have to demonstrate by "extensive analysis" that the laws of interested jurisdictions did not pose "insuperable obstacles" to class certification. As Mr. Wajert points out, courts have generally found that common questions of fact do not predominate in medical device products cases. In the Panacryl Sutures litigation, the sutures were used in a variety of surgical procedures, which required different techniques and skill sets on the part of the surgeon and presented different risks of post-operative complications. Thus, it is not likely that any class would have been certified due to a lack of predominance of common issues, let alone a national class. For a further discussion of the policy and legal considerations that warrant denial of class actions in pharmaceutical and medical device litigation, take a look at the enthusiastic discussion of the decision in the Drug and Device Law Blog authored by Jim Beck and Dechert and Mark Herrmann at Jones Day.