In re Telectronics Pacing Systems, Inc.

Facts

Defendant, TPLC, Inc. (“TPLC”), is a Delaware corporation engaged in the business of designing, manufacturing, and marketing medical devices including the Accufix Atrial “J” Lead Pacemaker Model 330-801 and Model 329-701 (“J Lead pacemakers”). Approximately 25,000 J Lead pacemakers were implanted in hearts of United States residents. Between December 1988 and February 1993, TPLC received reports that at least seven J Lead pacemakers “retention wires” had fractured. The retention wire fracture can cause serious injury to the heart or blood vessels. On October 21, 1994, TPLC notified the Food and Drug Administration (“FDA”) that it was recalling all unsold J Lead pacemakers. TPLC’s President sent a letter to all doctors on November 3, 1994 notifying them that TPLC was voluntarily recalling all un-implanted J Lead pacemakers. TPLC did several things to control the situation: it established the Accufix Research Institute to manage the recall; it formed a Physicians Advisory Committee to provide advice concerning the management of lead patients; and it agreed to reimburse reasonable medical expenses for screening and J Lead extraction.

In 1995, Plaintiffs, Elise and Eugene Owens, brought suit against TPLC, alleging injury due to a defective J Lead pacemaker. The Owens claimed that TPLC’s negligent manufacture or design of the pacemaker caused the retention wire to fracture. The Panel on Multi-District Litigation (“MDL Panel”) selected an Ohio state court as the transferee court for all claims involving the J Lead pacemakers. Over 400 cases were pending before the Ohio court for pretrial proceedings. The court appointed a Plaintiffs’ Steering Committee (“PSC”) to coordinate discovery on behalf of Plaintiffs, and ordered PSC to file a Master Complaint. The court initially certified a worldwide class of all J Lead pacemaker implantees for the common issues of medical monitoring, negligence, strict liability, fraud, misrepresentation and breach of warranty. In February 1996, the court decertified the international class. TPLC moved to have the court reconsider the class certification. In July 1996, the court granted the motion to reconsider and decertified this case as a class action. Plaintiffs then filed a Renewed Motion for Class Certification, seeking to certify a nationwide class on claims of medical monitoring, negligence, strict liability, and punitive damages. Plaintiffs proposed one nationwide subclass for all medical monitoring claims, two negligence subclasses, four strict liability subclasses, and three punitive damages subclasses.