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Shot Heard ‘Round the World, Mesh Community Hits Social Media
May 4, 2016 | Legal Reader
By Jay W. Belle Isle
...She knows those risks all too well, having been injured by one of Ethicon’s devices. Ethicon is a subsidiary of Johnson & Johnson (J&J). -
Philly law firm sued for breach of contract by Florida expert witness from vaginal mesh litigation
May 4, 2016 | Penn Record
By Nicholas Malfitano
A Philadelphia law firm has been sued by a Melbourne, Fla.-based urogynecologist for two forms of breach of contract and unjust enrichment, in connection to the payment of costs associated with his participation in a successful vaginal mesh litigation. -
Three FDA Final Rules Slated for Release in May
May 4, 2016 | Regulatory Affairs Professional Society
By Zachary Brennan
Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products.
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Shot Heard ‘Round the World, Mesh Community Hits Social Media
May 4, 2016 | Legal Reader
By Jay W. Belle Isle
Women injured by pelvic mesh implants have found a new way to fight back. This is the shot heard ‘round the world, mesh community hits social media! The Mesh Awareness Movement (MAM) currently hosts parties every Friday night on Twitter, as well as keeping an active Facebook page.
The parties, alas, are not of the celebratory type. They are comprised of scores of victims, women whose lives have been painfully altered, gathering to raise awareness of yet another medical device that is ruining women’s lives. The Twitter parties are held every Friday night from 8PM to 11PM EST and are attended not just by mesh victims, but also by women who have been injured by other medical implants the FDA has deemed “safe.”
One of the participants, Janis Urban, whom I had the pleasure of speaking with, said, “Our tweets bring awareness to warn others who may be considering a mesh implant. They need to know the risks of mesh.” She knows those risks all too well, having been injured by one of Ethicon’s devices. Ethicon is a subsidiary of Johnson & Johnson (J&J).
Mrs. Urban (@janurban12 on Twitter) is one of the lead participants of the Friday night Twitter parties, along with Tammy Jackson (@TammyJa54001341) and the Mesh Awareness Movement (@MeshAwareness). To date, there have been about 1,500 tweets sent, many with J&J, the largest mesh producer, as the focus.
And, Johnson & Johnson is paying attention.
Tammy Jackson wrote directly to Johnson & Johnson at @JNJcares and #JNJNews.
J&J’s reply:
“Thanks for alerting us to these Tweets. We’ll continue to monitor the situation, and we appreciate you letting us know. Sincerely, The Johnson & Johnson Team.”
The Twitter parties started on March 11, focusing on J&J for the first two weeks, using the hashtags:#JNJHurtWomen,#JNJhurtsforprofit, and#FDA.
Mrs. Urban posts several tweets and Facebook updates on the MAM’s page daily, encouraging other members to share them.
“It couldn’t be any easier for them to Tweet,” she says. “All they need to do is click on the tweet posted and if they are a member of Twitter it takes them to their Twitter page and they sign in and can retweet or add hashtags-addresses.”
Others have noticed, too. Joleen Chambers, a patient advocate, said the idea was “brilliant” as Twitter provides a level playing field for those injured. Anyone can tweet a company, a group or an individual and the Twitterverse can see it.
In fact, that’s why it’s the “shot heard ‘round the world.” Through the power of social media, injured women and their supporters from around the globe can interact in a heartbeat. Here are just a handful of the groups out there:Scottish Mesh Survivors #ScottishMeshSurvivorsSling the Mesh @MeshCampaign,Mesh Me Not,Mesh Problems,MAM,Mesh News Desk,Peggy Day Writes, andGroups in New Zealand, Australia.
Mrs. Urban has plans to reach out to other groups of women injured by FDA-approved devices, such as Essure and power morcellators.
As is the case with many of the E-Sisters (women injured by Essure), mesh victims are stepping out into the open to put a human face on what the FDA and device manufacturers see only as statistics.
Mrs. Urban put it well when she said, “You got to put a face on it. We are as invisible as the mesh that’s been implanted in our body. No more suffering in silence. You’ve seen the inflammation on the outside, what is going on in the inside?”
Hashtags used to spread the mesh word have been:#Pain,#Autoimmune,#Toxic,#Untested,#LivesMatter#FDA,#Congress,#Media,#Regulations,#Doctors,#Polypropylene,#Justice,#PelvicMesh,#MeshInjury,#HerniaMesh,#LivesRuined,#MedicalDevice,#HealthcareReform,#HSM, (healthcare social media),#healthhacks,#healthfit,#ehr (electronic health records),#patient safety,#medicalresearch, and the list goes on.
MAM welcomes all injured women and their supporters to join the Friday night Twitter parties, as well as to tweet and post to Facebook on a daily basis.
Learn more at the MAM Facebook page.
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Philly law firm sued for breach of contract by Florida expert witness from vaginal mesh litigation
May 4, 2016 | Penn Record
By Nicholas Malfitano
A Philadelphia law firm has been sued by a Melbourne, Fla.-based urogynecologist for two forms of breach of contract and unjust enrichment, in connection to the payment of costs associated with his participation in a successful vaginal mesh litigation.
On Wednesday, Ralph Zipper M.D. (doing business as Zipper Urogynecology Associates) filed a lawsuit against Kline & Specter, charging the firm breached its contract with him when it allegedly failed to pay him fully for services rendered as an expert witness in a Philadelphia-based vaginal mesh trial.
Zipper’s practice specializes in urogynecology, which is “the treatment of pelvic floor dysfunction in women which includes, but is not limited to, the treatment of stress urinary incontinence and pelvic floor prolapse and care for complications from vaginal mesh procedures.”
Zipper asserts his longtime experience in training doctors on the use of vaginal mesh and treatment of patients with urogynecological health issues has caused him to be tapped as an expert physician witness in numerous vaginal mesh trials. Zipper claims he has written more than 20 specific case opinions and four general opinions on vaginal mesh litigation.
According to Zipper’s suit, Kline & Specter’s law practice represents women who suffered injuries as a result of vaginal mesh products in litigation against the mesh manufacturers.
Prior to May 2015, Zipper says Kline & Specter contacted him to act as an expert witness in a case they brought in the Philadelphia County Court of Common Pleas, on behalf of their client Patricia Hammons against Ethicon, Inc.
In addition to Kline & Specter, Zipper says Florida law firm Aylstock Witkin Kreis & Overholtz participated in depositions and trial preparation in the Hammons case.
Per their agreement, Kline & Specter reportedly agreed to pay Zipper a rate of $700 per hour for services to assist with the Hammons case and to reimburse Zipper for expenses incurred therein. Zipper was instructed to submit invoices for these costs to the Aylstock firm.
Zipper began his expert consulting in May 2015, participated in a deposition for the case at his office that September, and the Hammons case proceeded to trial in December. Over the course of these proceedings, Zipper continually submitted invoices for payments for his services.
Lead counsel on the Hammons case and Kline & Specter senior partner, Shanin Specter, wrote Zipper an e-mail in December where he described Zipper's trial preparation as both “extraordinary” and “well beyond anything I’ve seen in the 32 years I’ve practiced law.”
On Dec. 23, a jury entered a verdict in Hammons’ favor for $12.5 million.
Zipper argued Kline & Specter paid him a total of $147,900 for his services and $608.27 for his expenses associated with the Hammons case, with an alleged amount of $250,150 plus interest from Dec. 15 of last year still outstanding.
Zipper thus filed suit for breach of oral contract, unjust enrichment, quantum meruit and breach of implied-in-fact contract against Kline & Specter.
The plaintiff is seeking damages for services rendered of $250,150, plus interest from Dec. 15 to the present, court costs and other relief in this case.
When contacted, attorneys from Kline & Specter had no comment regarding Zipper’s litigation.
The plaintiff is represented by Bradley Jacob Anderson and J. Timothy Schulte of Zimmerman Kiser & Sutcliffe in Orlando, Fla.
The defendant has not yet secured legal representation, according to court records.
U.S. District Court for the Middle District of Florida case 6:16-cv-00712
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Three FDA Final Rules Slated for Release in May
May 4, 2016 | Regulatory Affairs Professional Society
By Zachary Brennan
Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products.Device Trial Data
The final rule on medical device clinical studies, first proposed in 2013, is intended to update the standards to allow for FDA to accept data from clinical studies conducted outside the US.
“As part of this proposed rule, we are also proposing to amend the IDE [investigational device exemption] and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type,” the agency says.
The final rule would rely upon conformance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC), and obtaining and documenting the freely given informed consent of study subjects.Postmarket Reporting
The final rule on postmarket safety reporting for combination products (drug/device, and/or biologic), meanwhile, was set to be released sometime last month and first proposed in 2009.
The rule will clarify the postmarket safety reporting requirements that apply when drugs, devices and biologics are combined to create such a combination product. The rule comes as significant advances have been made in the development of combo products over the past decade and as stakeholders have expressed concern about the lack of concrete information regarding the postmarketing safety reporting regulatory requirements of such products.
The rule establishes various guidelines on what types of alerts and adverse events should be reported, as well as specific examples of different combo products and how information should be sent to FDA.Facility Reporting Requirements
And finally, after a decade of waiting, drug and biologic manufacturers, importers, repackagers, relabelers and “salvagers of marketed drugs” may see new final regulations this month on how to report to FDA where their facilities are located and what products are being manufactured there.
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