News Feed Item
Transvaginal Mesh Lawsuit News: FDA Inspection of American Medical Systems Manufacturing Facility Leads to Warning Letter, Bernstein Liebhard LLP Reports
|By PR Newswire
|April 21, 2014 02:19 PM EDT
NEW YORK, April 21, 2014 /PRNewswire/ -- As thousands of transvaginal mesh lawsuits (http://www.transvaginalmeshlawsuithelp.com/) filed against American Medical Systems, Inc. continue to move forward in federal court, Bernstein Liebhard LLP notes that a manufacturing facility operated by the company was recently the subject of a warning letter issued by the U.S. Food & Drug Administration (FDA). In a regulatory filing with the U.S. Securities and Exchange Commission (SEC), Endo Health Solutions, Inc., the parent of American Medical Systems, disclosed that the April 10th letter followed the February inspection of a plant in Minnetonka, Minnesota, which uncovered issues "pertaining to process validation, risk analysis and corrective and preventive action procedures." While the April 16th SEC filing indicates that American Medical Systems has already submitted a corrective action plan to the FDA, the facility will have to undergo a follow-up inspection at some point in the future to ensure that all corrective actions have been put in place.
"Our Firm is representing hundreds of women who were allegedly injured by pelvic mesh devices manufactured by American Medical Systems, and continue to closely monitor regulatory issues involving the company," says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm continues to evaluate vaginal mesh lawsuits on behalf of women who suffered mesh erosion, chronic pain, and organ damage, allegedly due to devices marketed by American Medical Systems and Boston Scientific, as well as C.R. Bard, Inc. and Ethicon, Inc.
Vaginal Mesh Lawsuits
American Medical Systems is currently named a defendant in nearly 17,000 transvaginal mesh lawsuits that have been filed in the U.S. District Court, Southern District of West Virginia, on behalf of women who allegedly suffered serious vaginal mesh complications due to devices used to treat stress urinary incontinence and pelvic organ prolapse. Jeffrey S. Grand, a partner with Bernstein Liebhard LLP, is serving on the Plaintiffs' Steering Committees for this proceeding. According to Court's website, the litigation's first bellwether trial of a case involving American Medical Systems is scheduled to begin on June 2, 2014. (In Re American Medical Systems, Inc. - MDL No. 2325)
In addition to his work in the American Medical Systems litigation, Mr. Grand is also serving on the Plaintiffs' Steering Committees in several other multidistrict litigations established for transvaginal mesh lawsuits in the Southern District of West Virginia. These include proceedings involving Boston Scientific Corp., (MDL 2326), C.R. Bard, Inc. (MDL 2325) and Ethicon, Inc. (MDL No. 2327).
Mr. Grand is currently serving as Co-Liaison Counsel in two consolidated proceedings established for C.R. Bard and Ethicon mesh lawsuits in New Jersey's Atlantic Superior Court. He was also a member of the trial team on the first Ethicon trial, which ended in March with an $11 million verdict for the Plaintiff. (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).
Alleged victims of vaginal mesh complications may be entitled to compensation for their injury-related damages. Find out more about filing a transvaginal mesh lawsuit by visiting Bernstein Liebhard LLP's website, or the Firm's Facebook page: https://www.facebook.com/meshlawsuit. To obtain a free, confidential and no-obligation case review, please call (888) 340-4807.
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 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since the list was first published in 2003.
Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
ATTORNEY ADVERTISING. © 2014 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (888) 340-4807. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Felecia L. Stern, Esq.
Bernstein Liebhard LLP
Logo - http://photos.prnewswire.com/prnh/20120202/MM47134LOGO
SOURCE Bernstein Liebhard LLP
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications.
Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Jul. 30, 2016 02:30 PM EDT Reads: 1,040
Security, data privacy, reliability, and regulatory compliance are critical factors when evaluating whether to move business applications from in-house, client-hosted environments to a cloud platform. Quality assurance plays a vital role in ensuring that the appropriate level of risk assessment, verification, and validation takes place to ensure business continuity during the migration to a new cloud platform.
Jul. 30, 2016 02:00 PM EDT Reads: 501
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Jul. 30, 2016 01:30 PM EDT Reads: 966
Ovum, a leading technology analyst firm, has published an in-depth report, Ovum Decision Matrix: Selecting a DevOps Release Management Solution, 2016–17. The report focuses on the automation aspects of DevOps, Release Management and compares solutions from the leading vendors.
Jul. 30, 2016 01:00 PM EDT Reads: 1,852
Continuous testing helps bridge the gap between developing quickly and maintaining high quality products.
But to implement continuous testing, CTOs must take a strategic approach to building a testing infrastructure and toolset that empowers their team to move fast.
Download our guide to laying the groundwork for a scalable continuous testing strategy.
Jul. 30, 2016 01:00 PM EDT Reads: 2,121
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle.
In his session at 18th Cloud Expo, ...
Jul. 30, 2016 12:00 PM EDT Reads: 1,349
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
Jul. 30, 2016 11:30 AM EDT Reads: 1,389
StackIQ has announced the release of Stacki 3.2. Stacki is an easy-to-use Linux server provisioning tool. Stacki 3.2 delivers new capabilities that simplify the automation and integration of site-specific requirements. StackIQ is the commercial entity behind this open source bare metal provisioning tool.
Since the release of Stacki in June of 2015, the Stacki core team has been focused on making the Community Edition meet the needs of members of the community, adding features and value, while ...
Jul. 30, 2016 11:00 AM EDT Reads: 627
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage.
Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Jul. 30, 2016 11:00 AM EDT Reads: 535
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Jul. 30, 2016 10:45 AM EDT Reads: 1,088
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA.
This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
Jul. 30, 2016 10:15 AM EDT Reads: 1,046
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
Jul. 30, 2016 10:15 AM EDT Reads: 1,513
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market?
In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
Jul. 30, 2016 10:00 AM EDT Reads: 2,182
ReadyTalk has expanded the capabilities of the FoxDen collaboration platform announced late last year to include FoxDen Connect, an in-room video collaboration experience that launches with a single touch.
With FoxDen Connect, users can now not only engage in HD video conferencing between iOS and Android mobile devices or Chrome browsers, but also set up in-person meeting rooms for video interactions. A host’s mobile device automatically recognizes the presence of a meeting room via beacon tech...
Jul. 30, 2016 10:00 AM EDT Reads: 530
Deploying applications in hybrid cloud environments is hard work. Your team spends most of the time maintaining your infrastructure, configuring dev/test and production environments, and deploying applications across environments – which can be both time consuming and error prone. But what if you could automate provisioning and deployment to deliver error free environments faster? What could you do with your free time?
Jul. 30, 2016 09:45 AM EDT Reads: 521