Description of MDL No. 01-1396

In re St. Jude Medical, Inc. Silzone Heart Valves Product Liability Litigation

This multidistrict litigation currently consists of thirty-three federal court cases currently pending before this Court involving St. Jude Medical’s Silzone® coated heart valve products. (There are also cases pending in various state courts.) These cases all involve allegations concerning mechanical heart valves with Silzone® coated sewing cuffs manufactured by the defendant, St. Jude Medical, Inc.

In March 1998, the FDA granted approval to St. Jude Medical to sell mechanical heart valves with Silzone® coating in the United States. On January 21, 2000, St. Jude Medical voluntarily recalled all of its non-implanted mechanical heart valves with Silzone® coating. This recall followed the company’s receipt of information from a clinical trial showing a small but statistically significant increase in the number of explants due to paravalvular leak.

Plaintiffs allege that the Silzone-coated heart valves caused some patients to die, while others experienced serious personal injury, including requiring surgery, to replace the Silzone valve. Other plaintiffs allege that they require an increased level of medical monitoring because they have an implanted Silzone valve. Plaintiffs further allege that mechanical heart valves with Silzone coating were defectively designed and/or manufactured and were marketed without adequate warnings and raise certain statutory claims.

In denying the plaintiff’s allegations, St. Jude Medical alleges that the Silzone valve was not defectively designed or manufactured and that that product was sold with proper warnings concerning the complications alleged in plaintiff’s complaints. St. Jude Medical also contends that Silzone valve patients require only the diligent normal monitoring recommended for all patients with mechanical heart valves.

The Judicial Panel on Multidistrict Litigation determined that centralizing the St. Jude Medical Silzone Heart Valve cases were appropriate. Based on a number of factors, the Judicial Panel determined that the District of Minnesota was an appropriate forum. All St. Jude Medical Silzone Heart Valve federal cases have been ordered transferred to the District of Minnesota, and assigned to the Honorable John R. Tunheim as MDL No. 01-1396.

Judge Tunheim is coordinating discovery and other pretrial matters in these cases. Subsequent St. Jude Medical Silzone cases filed in federal court will ordinarily be transferred to the District of Minnesota and become part of MDL No. 01-1396 as “tag along” cases. When discovery and other pretrial matters have been concluded, the cases that constitute MDL No. 01-1396 will be transferred back to the districts in which they were originally filed for trial or other proceedings.