Settlement Reached in Mesh Class Actions Against Johnson & Johnson Medical and Ethicon
Shine Lawyers welcomed a $300 million settlement in two class actions brought against Johnson & Johnson Medical and Ethicon which sought damages on behalf of Australian women who received pelvic mesh implants. A First Class Action, to Trial for Seven Months
The settlement reached on 9 September 2022 is the largest settlement in a product liability class action in Australian history, and is subject to approval by the Federal Court. The first class action was filed in the Federal Court on 15 October 2012, and ran to trial over seven months between July 2017 and February 2018. Judgment was delivered in the applicants’ favor in November 2019. Johnson & Johnson Medical and Ethicon appealed to the Full Court of the Federal Court, which dismissed the appeal in March 2021. In November 2021 the High Court dismissed Johnson & Johnson Medical’s application for special leave to appeal. The Second Class Actions Was Filed Last April
The second class action was filed in April 2021 on behalf of women who received their implants on or after 4 July 2017 and were not eligible to join the first class action. Shine Lawyers’ Class Actions Practice Leader Rebecca Jancauskas said the settlement will help support women’s treatment needs. “We welcome this settlement which brings the litigation to an end. If the Federal Court approves the settlement our focus will shift to the important task of distributing the settlement to group members,” she said. The complications which can result from the implants includes erosion of the mesh into surrounding organs, chronic pain, painful sexual intercourse and incontinence. “Women who believe they may be eligible to receive compensation should contact Shine Lawyers at [email protected] ”
9 Types of Implants Were Included in the Lawsuit
Women implanted with one or more of the below devices in Australia up to 30 June 2020 who suffered one or more complications as a result may be eligible for compensation. The implants included in the proceedings are:
Gynecare Prolift Pelvic Floor Repair Systems (Anterior, Posterior and Total);
Gynecare Prosima Pelvic Floor Repair Systems (Anterior, Posterior and Combined);
Gynecare Prolift+M Pelvic Floor Repair Systems (Anterior, Posterior and Total);
Gynecare TVT;
About the class action:
Shine Lawyers filed two class actions against Ethicon Sarl, Ethicon Inc. and Johnson & Johnson Medical Pty Ltd (the respondents) on behalf of Australian women who suffered complications after receiving one or more Gynecare prolapse mesh and incontinence tape implants. The trial in the first class action began in the Federal Court in Sydney on 4 July 2017, and concluded in February 2018. Judgment was handed down in the applicants’ favor in November 2019. The decision was appealed by the respondents and the Full Court of the Federal Court dismissed the appeal on Friday 5 March, 2021. On 5 November 2021 the High Court dismissed the respondents’ application for special leave to appeal. In April 2021, Shine Lawyers filed a second class action against the respondents in the Federal Court on behalf of women implanted with one or more of the Gynecare prolapse mesh and incontinence tape implants from July 2017 to include those women who had not been eligible to join the first class action which was filed in 2012. Shine Lawyers funded these two actions. J&J has faced similar lawsuits in the US, Europe and Canada, Reuters reported. Earlier this year, a California court ordered the pharmaceutical company to pay $302m for concealing the risks of Ethicon’s pelvic mesh products. The U.S. Main Three Drug Distributors, J&J Included, to Pay Opioid Claims to the Native American Tribes 
Johnson & Johnson was among the drug distributors involved in another resounding settlement recently. The U.S. three key drug distributors, McKesson, Cardinal Health and AmerisourceBergen, and Johnson & Johnson have settled up to $665 million opioid claims with Native American tribes who considered themselves harmed by continuous exposure to highly addictive painkillers, the Washington Post reported. According to the deal, McKesson, Cardinal Health, and AmerisourceBergen would pay $515 million over seven years and Johnson & Johnson would contribute $150 million in two years to the federally recognized tribes, resolving litigation in dozens of states with tribal reservations. More than 400 Native American tribes reached a $590-million settlement with Johnson & Johnson and three other drug distributors, according to court documents filed, on February 1st, in the U.S. District Court in Cleveland. The settlement with distributors includes $75 million they agreed in September 2021 to pay the Cherokee Nation in Oklahoma. Purdue Pharma – A $6 Billion Settlement Last March
Another resounding settlement is that involving Purdue Pharma and OxyContin, a highly addictive prescription pain medication and opioid. The privately-owned pharmaceutical company, Purdue Pharma is currently facing condemnation for its role in the administration of this dangerous drug. A settlement was reached in March 2022, totaling $6 billion. The settlement has prompted several state attorney generals to abandon lawsuits they had in place against the owners of Purdue Pharma, the Sackler family. Dropping the lawsuits was in exchange for an increase in personal holdings payments from the company.

Settlement Reached in Mesh Class Actions Against Johnson & Johnson Medical and Ethicon

August 05, 1997 |(Bloomberg News)
Johnson & Johnson agreed to buy Gynecare Inc. for stock valued at about $79 million, or $8.46 a share. The maker of medical devices, drugs and consumer-health products said buying Gynecare would expand its line of women's health products. The transaction is expected to close by the end of October, said J&J. Menlo Park-based Gynecare would become part of J&J's Ethicon Inc. division, which sells wound-closing and other surgical products. Separately, Gynecare said its application for approval for its ThermaChoice therapy system to treat uterine bleeding will be reviewed by federal regulators in early October. The thermal device was Gynecare's initial product in development and is approved for marketing in Europe and Canada. Gynecare last year lost $10.2 million, or $1.24 a share, on sales of $962,000. Shares of Gynecare fell 38 cents to close at $8.13 on Nasdaq. New Brunswick, N.J.-based J&J shares fell 13 cents to $60.94 on the NYSE. MORE:

Johnson & Johnson Will Buy Gynecare - latimes

More than 12,700 People Sign Petition to Ban Power Morcellator Surgery, Bernstein Liebhard LLP Reports
The family of a Missouri woman has filed a power morcellator lawsuit ( http://www.morcellatorlawsuit2015.com )  against Ethicon, Inc., which alleges one of the company’s Gynecare morcellators allowed an aggressive form of uterine sarcoma to spread throughout her body, ultimately leading to her death, Bernstein Liebhard LLP reports. According to their complaint, which was filed on December 3rd in the U.S. District Court, Western District of Missouri, the Decedent underwent a minimally-invasive procedure to remove uterine fibroids in December 2012, at which time a Gynecare morcellator was used to cut tissue into small pieces in order to allow for its removal through a small abdominal incision. The lawsuit alleges the morcellator caused undetected leiomyosarcoma to spread beyond her uterus , which resulted in the rapid upstaging of the disease to its most deadly stage. (Case 4:14-cv-01074-JTM)
“Our Firm has heard from a number of women, as well as their families, who also allege that uterine morcellation resulted in the upstaging of a deadly cancer. We are monitoring the litigation involving this issue very closely,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is providing free legal consultations to women who were diagnosed with advanced uterine cancers following uterine morcellation. Uterine Morcellation and Cancer
The U.S. Food & Drug Administration (FDA) has been reviewing the association between uterine morcellation and cancer since April, when it first discouraged the use of power morcellators in hysterectomies and fibroid removal procedures. * On November 24th, the agency issued a second alert that warned against the use of the devices in most women, and asked power morcellator manufacturers to add a new black box warning – the strongest possible safety notice – regarding this life-threatening complication to their labels. In its most recent morcellator cancer warning, the FDA noted that the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or fibroid removal surgery is 1 in 352, while the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. Both of these estimates are higher than the clinical community previously understood. A power morcellator can disseminate these cells beyond the uterus, upstaging the disease and greatly reducing a woman’s chances for long-term survival, the agency said. In July, Ethicon, a unit of Johnson & Johnson announced that it was removing its Gynecare Morcellex, Gynecare X-Tract and Morcellex Sigma morcellators from the market. **
Alleged victims of uterine sarcoma or other cancers allegedly spread via power morcellation may be entitled to compensation for their injury-related damages. To learn more about filing a morcellator lawsuit, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call 800-511-5092. *fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm, FDA, April 17, 2014
***ethicon.com/sites/default/files/managed-documents/Ethicon%20Morcellation%20Devices%20Customer%20Letter%20Final.pdf, Ethicon, Inc., July 30, 2014
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. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. 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 it was first published in 2003. Bernstein Liebhard LLP
New York, New York 10016
800-511-5092
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, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter. Contact Information:

Morcellator Lawsuit Alleges Ethicon Gynecare Morcellator Allowed Deadly Uterine Sarcoma to Spread Led to Missouri Womans Death Bernstein Liebhard LLP Reports

The firm is currently offering GYNECARE PROLIFT transvaginal mesh lawsuit evaluations for those who allege they sustained injuries from their vaginal mesh implants designed to treat vaginal prolapse in women.PRWEB January 10 2014  A Jan. 7 protective order...

New Order Issued in GYNECARE PROLIFT Transvaginal Mesh Lawsuit Consolidation Ensures Cases Move Forward Rottenstein Law Group LLP Reports

The Firm is representing numerous women who suffered serious vaginal mesh complications allegedly due to the defective design of Ethicon Inc.s Gynecare pelvic mesh products.New York New York PRWEB December 06 2013  Plaintiffs in transvaginal mesh lawsuits...

Transvaginal Mesh Lawsuit News Bernstein Liebhard LLP Notes New Plaintiff Filing in Federal Ethicon Vaginal Mesh Litigation

Funding Date

Pre-Money Valuation

Post-Money Valuation

Amount Raised

Shares Authorized

Issuance Price

Dividend Rate

Liquidation Preferences

Liquidation Price

Participation

Conversion Price

Anti Dilution

General Voting

Board Voting

Par Value

Acq - P2P

Gynecare designs, develops and markets medical instruments. The company offers minimally invasive medical devices for the treatment of uterine disorders.

Gynecare

Johnson & Johnson

November 19, 2021 11:03 AM Eastern Standard Time
MINNEAPOLIS--( BUSINESS WIRE )--Uromedica, Inc. announces today that four new Category I CPT (Current Procedural Terminology) codes have been assigned to their FDA-approved product, ProACT™ Adjustable Continence Therapy for Men and will be effective January 1st, 2022. The new CPT-I codes will be: 53451 (bilateral insertion), 53452 (unilateral insertion), 53453 (removal), and 53454 (percutaneous adjustment of balloon(s) fluid volume). The ProACT Therapy previously received Category III codes from the Center of Medicare Services in July 2019. Per Jonathan Rubenstein, MD and Mark Painter with the Urology Times: “The reason for the change was that the maturation of data and use of these procedures met the American Medical Association’s criteria to achieve a Category I status.”
“With hundreds of successful commercial implants across the US already, Uromedica is excited about this change to Category I codes and we look forward to helping more men regain their continence,” said Tim Cook, PhD, President and CEO of Uromedica. About ProACT
The ProACT™ Adjustable Continence Therapy for Men is a minimally invasive surgical treatment option for men who have stress urinary incontinence as a result of radical prostatectomy (removal of the prostate) due to prostate cancer or transurethral resection of the prostate due to prostate enlargement. The ProACT balloons are implanted where the prostate was removed or resected and then filled with fluid to apply pressure and support at the bladder neck. This pressure and support helps protect against accidental leaking of urine that can occur during a sneeze, cough, or physical activity. The implantation procedure can be performed in the Ambulatory Surgical Center (ASC) or Hospital Outpatient setting. After the ProACT procedure is completed, the balloon volume can be easily adjusted in an office setting to best meet patient’s needs for achieving continence. About Uromedica
Uromedica, Inc. is a privately held, Minnesota-based medical device company that has developed and manufactures a long-term implantable balloon therapy for the treatment of stress urinary incontinence in men and women. ProACT has been implanted in over 11,000 patients worldwide since 2002. Interested physicians or patients may visit www.uromedica-inc.com . Contacts

Uromedica Announces New CPT-I codes for ProACT™ Adjustable Continence Therapy for Men

MINNEAPOLIS–(BUSINESS WIRE)– #ProACTTherapy –Uromedica, Inc. announces today that four new Category I CPT (Current Procedural Terminology) codes have been assigned to their FDA-approved product, ProACT™ Adjustable Continence Therapy for Men and will be effective January 1st, 2022. The new CPT-I codes will be: 53451 (bilateral insertion), 53452 (unilateral insertion), 53453 (removal), and 53454 (percutaneous adjustment of balloon(s) fluid volume). The ProACT Therapy previously received Category III codes from the Center of Medicare Services in July 2019. Per Jonathan Rubenstein, MD and Mark Painter with the Urology Times: “The reason for the change was that the maturation of data and use of these procedures met the American Medical Association’s criteria to achieve a Category I status.”
“With hundreds of successful commercial implants across the US already, Uromedica is excited about this change to Category I codes and we look forward to helping more men regain their continence,” said Tim Cook, PhD, President and CEO of Uromedica. About ProACT
The ProACT™ Adjustable Continence Therapy for Men is a minimally invasive surgical treatment option for men who have stress urinary incontinence as a result of radical prostatectomy (removal of the prostate) due to prostate cancer or transurethral resection of the prostate due to prostate enlargement. The ProACT balloons are implanted where the prostate was removed or resected and then filled with fluid to apply pressure and support at the bladder neck. This pressure and support helps protect against accidental leaking of urine that can occur during a sneeze, cough, or physical activity. The implantation procedure can be performed in the Ambulatory Surgical Center (ASC) or Hospital Outpatient setting. After the ProACT procedure is completed, the balloon volume can be easily adjusted in an office setting to best meet patient’s needs for achieving continence. About Uromedica
Uromedica, Inc. is a privately held, Minnesota-based medical device company that has developed and manufactures a long-term implantable balloon therapy for the treatment of stress urinary incontinence in men and women. ProACT has been implanted in over 11,000 patients worldwide since 2002. Interested physicians or patients may visit www.uromedica-inc.com . Contacts

March 10, 2021 01:02 PM Eastern Standard Time
MINNEAPOLIS--( BUSINESS WIRE )--Uromedica, Inc. announces the initiation of its FDA Investigational Device Exemption trial for ACT® to evaluate its safety and efficacy for treatment of female SUI. Stress urinary incontinence is the accidental leakage of urine that can occur when sneezing, coughing, or performing physical activity. The investigational intent of the ACT trial, a post-operatively adjustable, minimally invasive outpatient procedure, is to assess safety and efficacy for women who suffer from moderate or severe SUI. The ACT protocol is a non-randomized trial expected to enroll up to 167 subjects with 12-month follow-up in which provocative pad weight test will be the primary clinical endpoint. FDA has permitted up to 11 sites in the U.S. to enroll patients. To learn more about the ACT study click here . Michael Feloney, M.D., urologist and Chairman of the Urology Department at Creighton University in Omaha, Nebraska, performed the first ACT implantations in early February 2021. Dr. Feloney stated: “ACT offers a unique approach to the management of female stress urinary incontinence. It is exciting to be participating in this FDA trial at Creighton University Medical Center. I am confident that ACT will be similar to ProACT in providing relief for my patients suffering from stress urinary incontinence.” ProACT™, Adjustable Continence Therapy for Men, was FDA-approved in 2015 for the treatment of SUI in men after prostate surgery. Timothy Cook, PhD, President and CEO of Uromedica commented: “Uromedica is very pleased to have begun our ACT trial. We are fortunate to be working with highly trained and skilled surgeons in a number of premier academic Urologic and Urogynecologic practices.“
Adjustable Continence Therapy for Women
Designed to be adjustable after implantation without further surgery, the ACT consists of two small silicone balloons connected with tubing to a filling port. The balloons are surgically placed next to the bladder and the ports are placed underneath the skin for later access and adjustment. The fluid-filled balloons provide support at the bladder neck, protecting against accidental urine leakage. About Uromedica
Uromedica, Inc. is a privately held medical device company that has developed and manufactures the ACT and ProACT devices for women and men, respectively, to treat SUI. Learn more at www.uromedica-inc.com . Contacts

First Patients Enrolled in Uromedica’s Adjustable Continence Therapy (ACT®) for Female Stress Urinary Incontinence (SUI) Trial

10:32 EDT 2 Nov 2017 | Businesswire
Uromedica, Inc., today announced that it has successfully completed its      first US commercial implant of ProACT™ Adjustable Continence Therapy for      Men. The procedure was carried out by Dr. Steven Nash in Overland Park,      KC. “We have eagerly waited for the ProACT procedure to be available in      the United States. Our patients who were part of the ProACT trial have      been great ambassadors as to how great the procedure works. They have      been a testament to the major improvement in their quality of life. Those patients’ excellent responses have created a wave of referrals      from Urologists within our group. We believe the ProACT procedure will      revolutionize the minimally invasive treatment of male stress incontinence ,” said Nash. Related Biotechnology, Pharmaceutical and Healthcare News
About Post- Prostatectomy Stress Urinary Incontinence and the ProACT      Therapy
Men who have undergone radical prostatectomy or transurethral resection      of the prostate (TURP) are at risk of Stress Urinary Incontinence (SUI). “Uromedica is excited to deliver the ProACT Therapy to improve the      quality of life for men struggling with any level of Stress Urinary      Incontinence,” said Tim Cook, PhD, President and CEO of Uromedica. “ProACT has been used to profound effect in Europe for over 15 years. We      are happy to finally bring this therapy to men who are in real need of      this treatment in the United States.”
The ProACT therapy consists of two small, adjustable silicone balloons      connected with tubing to a filling port. The implantation procedure      lasts approximately 30 minutes and can be performed in Ambulatory      Surgical Centers or in the Hospital Outpatient setting. The balloons are      surgically placed in the area where the prostate was removed or resected      and the ports are placed underneath the skin. The fluid-filled balloons      provide pressure and support at the bladder neck which protects against      accidental leaking of urine that can occur during a sneeze, cough, or      physical activity. When there is a need to urinate, passing urine      requires only a normal amount of bladder effort. The balloon volume can      be adjusted at any time to achieve optimal continence. About Uromedica
Uromedica, Inc. is a privately held, Minnesota-based medical device      company that has developed and manufactures a long-term implantable      balloon device for the treatment of stress urinary incontinence in men      and women. ProACT has been implanted in over 8,500 patients worldwide      since 2002. Interested physicians or patients may visit  www.proact-for-men.com . View source version on businesswire.com: http://www.businesswire.com/news/home/20171102006018/en/
Uromedica, Inc.

UROMEDICA Announces Successful First US Commercial Implant of ProACT Adjustable Continence Therapy for Men

Uromedica

Loan

Uromedica develops minimally invasive medical devices that treat unmet medical needs in the area of urinary incontinence and related disorders. Products (sold under the ACT and ProACT brands) are based on adjustable balloon technology. Conditions being treated are post-prostatectomy incontinence in men and stress incontinence in women (after earlier interventions have failed).

Wells Fargo Success Story

Professional Services

Platform Overview

Compare Gynecare vs Uromedica

Customers evaluate the quality of Gynecare's products using the following success metrics.