National
On November 17, 2006, the FDA announced that it approved the marketing of silicone gel-filled breast implants made by Allergan Corp. (formerly Inamed Corp.) and Mentor Corp. The FDA stated that “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions.”
The approval comes with conditions, however, requiring the companies to continue to conduct post-marketing research for 10 years. They also must conduct a focus group study of the patient labeling and continue laboratory studies to further characterize types of device failure. Tracking of each implant is also required in the event that health professionals and patients need to be notified of updated product information.
Philadelphia County
On October 28, 2003, the Honorable Victor J. DiNubile, Jr., released all 300+ pending silicone breast implant cases in the Court of Common Pleas of Philadelphia County. Monthly status conferences are held with liaison counsel, Judge DiNubile and Mary McGovern of the Complex Litigation Center in Philadelphia. Numerous Case Management Orders have been promulgated, which establish deadlines for all of the cases. Since the stay was lifted in Philadelphia County, the majority of the cases have either been discontinued or judgments of non-pros have been entered. At this point, only two cases remain active. The first trial is scheduled to begin in March of 2005.
York County
The Honorable Emanuel Cassimatis is coordinating the litigation in York County. He issued a General Scheduling Order dated April 7, 2004 which lifted the stay and established deadlines for the cases pending in York County.
All Other Pennsylvania Cases
The Honorable R. Stanton Wettick, Jr. is coordinating the litigation in all counties except Philadelphia and York. By Orders dated December 4, 2003, he lifted the stay on all cases and established deadlines. By February 2, 2004, plaintiffs were to file Statements of Intent to Proceed in certain cases. By July 1, 2004, plaintiffs were to file Information Sheets in certain remaining cases. In response to those deadlines, numerous cases were discontinued or judgments of non pros were entered. No further deadlines have been set in the remaining cases.