by Mark Bauman | May 1, 2023 | Legal News, Silicone Breast Implant Litigation
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.
See the press release.
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.
by Mark Bauman | Apr 29, 2023 | Legal News, Silicone Breast Implant Litigation
(1) Background:
In the early 1990s, numerous lawsuits were commenced in Pennsylvania against silicone breast implant manufacturers, implanting physicians and hospitals alleging that silicone breast implants caused a host of injuries including systemic disease. The Pennsylvania Supreme Court set up a Coordinating Court to manage the silicone breast implant cases. The Chairperson is the Honorable R. Stanton Wettick, Jr. from Allegheny County.
O’Brien & Ryan, L.L.P. was appointed by the Supreme Court to act as liaison counsel on behalf of all Pennsylvania Plastic Surgeons. The firm’s role involves active participation in the day-to-day management of the litigation. In addition to representing individual doctors, the firm’s liaison role allows it to represent, when necessary, all defendant plastic surgeons regarding issues that affect all of the defendant doctors on a global basis. In this representation, the firm has actively participated in the preparation of pleadings, motions and briefs as well as attending hearings and arguments. Furthermore, as liaison counsel, the firm has worked closely with the Courts and liaison counsel for the plaintiffs, manufacturer and hospital defendants to develop the current trial programs throughout the state.
After a long stay of all silicone implant litigation, due in large part to the Dow Corning Bankruptcy, the the Coordinating Court released a handful of cases in 1998 to proceed to trial. The first case, Toledo v. Mitra, M.D., proceeded to trial on July 16, 2001 against the implanting plastic surgeon in which the plaintiff claimed that the doctor failed to obtain the patient’s informed consent prior to inserting silicone gel implants. Prior to trial, Judge Wettick issued an opinion precluding plaintiffs’ experts from testifying that silicone gel caused injury and/or persistent, chronic pain after removal of the implant. The issues were therefore limited to whether the doctor informed the patient of the risks of surgery. Plaintiffs took the position that the risks of the procedure included risks associated with the implants themselves and that the plaintiff should have been told about the alternative of saline implants. Damages were sought for pain, capsular contracture, lymphadenopathy, silicone granulomas, chest wall deformity, gel bleed/migration, hematoma, scarring and disfigurement. The trial, tried by our own Daniel F. Ryan, III, Esquire, resulted in a defense verdict.
