J&J Vaginal Mesh Implants Sold Without FDA Approval
Bernstein Liebhard reports on an alarming report published by Bloomberg News on March 21, 2012, revealing that Johnson & Johnson (“J&J”) vaginal mesh implants were sold for three years before the transvaginal surgical mesh device was approved by the U.S. Food and Drug Administration (“FDA”).* These J&J vaginal mesh implants are now the subject of more than 550 lawsuits filed by women who claim that the Gynecare Prolifit transvaginal surgical mesh caused them to sustain injuries.
According to Bloomberg News, J&J introduced the Gynecare Prolifit device in March 2005. The J&J vaginal mesh implant at issue was touted in the company’s annual report as an “innovative and effective surgical option” for women with weakened pelvic muscles. However, the FDA was unaware that J&J was selling the Prolifit until 2007. It only became apparent that the Prolifit was being marketed and sold once J&J sought approval for a related transvaginal surgical mesh product. In 2007, the Prolifit+M was being reviewed for approval. In the course of his evaluation, the lead FDA reviewer determined that the predicate J&J vaginal mesh should have also been submitted for approval. According to an FDA spokeswoman, the J&J vaginal mesh implants were distributed “without appropriate” clearance.
550 Lawsuits Stem From J&J Vaginal Mesh Implants
Bloomberg News reported that these transvaginal surgical mesh implants are now the subject of more than 550 lawsuits filed by women alleging that they were injured as a result of the J&J vaginal mesh products. In addition, a review of FDA data revealed that 123 complaints were filed with the agency about the Prolifit from 2005 to May 15, 2008, when the device received market clearance. Malfunctions, deaths or serious injuries stemming from the Prolifit were reported. Currently, the pelvic mesh litigation litigation against J&J is pending in New Jersey state court. To date, J&J has produced more than 2.3 million pages of documents. More than 70 company witnesses are expected to be deposed. Company documents as well as testimony elicited during depositions will prove to be important evidence in the litigation.
In light of this latest development, Bernstein Liebhard LLP partner Jeffrey S. Grand, who is serving as co-liaison counsel in the New Jersey transvaginal surgical mesh lawsuits against J&J and C.R. Bard, another medical device manufacturer, commented “This is symptomatic of a broken system where a manufacturer can unilaterally decide to put medical devices on the market without the FDA’s knowledge or approval.”
The lawyers at Bernstein Liebhard are actively filing cases in In re Pelvic Mesh/Gynecare Litigation, No. 6341-10 (N.J. Super Ct.), and In re Pelvic Mesh Litigation/Bard No. L-6339-10 (N.J. Super. Ct.), which are two consolidated actions of all the vaginal surgical mesh lawsuits filed in New Jersey state court.
Those who have experienced complications as a result of being implanted with transvaginal mesh may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries. For more information about filing a vaginal mesh lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at email@example.com. Our lawyers and staff understand the sensitive nature of the complications caused by transvaginal mesh and will answer your questions in a caring and sympathetic manner. Hundreds of women have shared their personal experiences with us, and we would be happy to speak with you.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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