Johnson & Johnson shareholders: are you listening? Divest or be complicit!

Jury delivers $20 million verdict against Johnson & Johnson in local vaginal mesh case

POSTED:APR 28 2017 03:07PM EDT

UPDATED:APR 28 2017 03:09PM EDT  FiDA Highlight

PHILADELPHIA, PA (WTXF) - On Friday, April 28, a jury handed down a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after being implanted with a vaginal mesh device.

The verdict was the third consecutive eight-figure award against the corporate giant in a mesh case in a Philadelphia courtroom.

The award—$2.5 million in compensatory and $17.5 million in punitive damages—for Peggy Engleman, now 56, of Cinnaminson, followed a three-week trial in Common Pleas Court in which her attorneys claimed the TVT-Secur medical device was not only defective but that J&J and its Ethicon subsidiary had failed to warn of its risks, risks they had been well aware of while continuing to market the product.

Engleman was implanted with the device in 2007 to relieve stress urinary incontinence, a leakage caused by things such as exercise or coughing. But within a month the TVT-Secur failed and Engleman's stress urinary incontinence returned.

She began experiencing pain and discomfort when the polypropylene mesh started to erode inside her body. Despite three subsequent surgeries, doctors were unable to remove all the remaining mesh.

As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.

“I'm happy I could be a voice for other women,” Engleman said after the verdict. “It's been a nightmare, and I feel justice was truly served today."

The vaginal mesh product in Engleman’s case, the TVT-Secur, was launched in September 2006 but, as her attorneys noted, J&J had already had numerous reports of high failure rates from countries all over the world.

"This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated," said lead plaintiff’s counsel Benjamin Anderson.

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“The jury made the right decision,” added Thornburgh. “They looked at the evidence and heard the testimony and decided that the company had rushed the product to the market, did woefully inadequate studies and didn’t warn about the risks. So we feel they made the right decision and our client will finally get justice.”

Said Gomez: “The jury spoke and they sent a message that J&J and Ethicon need to take responsibility.”

The verdict was the third straight against a J&J vaginal mesh product in which the plastic-like device eroded inside a patient, leaving shards of mesh that doctors were unable to entirely remove.

The first two cases, in 2015 and 2016 respectively, produced verdicts of $12.5 million for an Indiana woman and $13.5 million for a Toms River, N.J., woman.

FDA: Preventable Patient Harm - to regulate or not to regulate?

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Public Workshop - The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes, September 18-19, 2013

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes”.

The purpose of this workshop is to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making. It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers.

• Date, Time and Location
• Webcast
• Federal Register Notice
• Agenda
• Registration
• Public Comment
• Contact Us

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Date, Time and Location:

This meeting will be held September 18 and 19, 2013,  8:00 a.m. to 5:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Section A of the Great Room)
Silver Spring, MD, 20993

• FDA Campus Information, Travel Information, and Directions

Webcast

This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m. on September 11, 2013. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after September 12, 2013. If you have never attended a Connect Pro event, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit: http://www.adobe.com/go/connectpro_overview.

Preliminary Agenda

The agenda will be announced.

Registration to Attend the Workshop:

If you wish to attend this Workshop, you must register by 4:00 p.m. on September 11, 2013.  There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

Attendance  In-Person  Webcast Title     Mr. Mrs. Ms. None First Name * Last Name *   M.D.     Ph.D. Email* Please enter Email again for verification : Phone Number*  (No dashes or spaces in phone numbers please) Company or Organization * Request to Speak * Do you wish to make a presentation?  Yes  No Proposed title of presentation:

Public Comment

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov.  The docket number is FDA-2013-N-0865. 

Workshop Details

Food and Beverages will be available for purchase during the breaks.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contact Mimi Nguyen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5437, Silver Spring, MD 20993-0002, 301-796-4125, email: Mimi.Nguyen@fda.hhs.gov.

Or

Nada Hanafi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3623, Silver Spring, MD 20993-0002, 301-796-5427, email:Nada.Hanafi@fda.hhs.gov.

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Page Last Updated: 07/29/2013 

FDA Patient Network Town Hall Live Chat May 21

May 21 FDA Patient Network Town Hall

Join a Live Chat

Upcoming Events - ***you must follow the link above and sign up on the FDA webpage****

Patient Network Town Hall with FDA Office of Health and Constituent Affairs Staff

Tuesday   May 21, 2013 - 

3:00pm to 4:00pm ET 

2:00pm to 3:00pm CT

1:00pm to 2:00pm PT

Join the FDA Office of Health and Constituent Affairs in a live chat with the director of it's patient liaison team, Richard Klein, to discuss the new FDA Patient Network and how patients can engage with the agency.  The live chat will be in the format of a town hall, allowing patients and patient advocates to discuss FDA's various mechanisms for including the patient perspective into regulatory decision-making, and how the new FDA Patient Network will facilitate broader patient engagement.

A presentation by Richard Klein

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm348661.htm

Harmed patient not healed by $3.35M verdict.

J&J Failed to Warn of VaginalMesh Risks, Jury Says

By David Voreacos - Feb 25, 2013 11:44 AM CT  FiDA highlight

           

           

Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled in the first verdict in more than 2,100 lawsuits filed over the device.

Jurors ordered J&J to pay $3.35 million to the nurse, Linda Gross, and her husband. Gross, 47, had 18 operations after the device was implanted.

J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor, the jury ruled. Jurors decided that the company failed to warn Gross’s implanting surgeon. The verdict in Atlantic City state court came in the first trial of claims Ethicon’s Gynecare Prolift injured women.

“This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” Gross attorney Adam Slater said in an interview.

Slater argued to jurors that company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. Gross blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.

‘Doctors Knew’

J&J claims the Prolift is safe and effective and it warned of the risks.

“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments on Feb. 15.

Superior Court Judge Carol Higbee is considering whether to allow Gross’s attorneys to pursue punitive damages, which are intended to punish the company. If so, the same jury would hear evidence and decide whether to award such damages. New Jersey caps punitive damages at five times compensatory damages, which in this case would be $16.75 million. Jurors delivered their verdict on the fifth day of deliberations.

Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.

Difficult Removal

The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. In August, J&J stopped selling four mesh devices in the U.S., including the Prolift. J&J, based in New Brunswick, New Jersey, said in June that it would end sales worldwide because the products lacked commercial viability, not because of their safety and effectiveness.

Slater claimed that Gross’s chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005. Slater said Ethicon knew the device caused pain and often became exposed through the vaginal skin. He said it hardened in women’s bodies and was difficult for surgeons to remove.

Gross, of Watertown, South Dakota, testified on Jan. 31 that her life has changed dramatically for the worse since her mesh was implanted. She said she is in constant pain and can no longer sit comfortably, and she has prescriptions for 20 different medicines to help with her pelvic problems.

“Who you see standing here now is not who I was,” Gross told jurors. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.”

Little Risk

Kevin Benson, the South Dakota surgeon who implanted her Prolift on July 13, 2006 to shore up pelvic muscles, was “so gung-ho” about the Prolift that she thought she needn’t worry. She understood from talking to Benson and reading a company brochure that she faced little risk and that the mesh could be removed easily, she said. Had she known all the risks, she said, she wouldn’t have chosen the Prolift.

Gross said she has had more than 400 visits to doctors and physical therapists for treatment, exams and tests, which have been “horrific.”

“I am fearful of dying because this pain is so bad,” she said.

On cross-examination, Jones sought to establish that before many of her surgeries, doctors warned that they may not help her pain. At one point, Gross shouted at Jones: “You’re trying to blame it on me, and it’s not right.”

Jurors saw the video deposition of Benson, who did three follow-up surgeries to remove portions of the mesh to help her with her pain. Other doctors also removed parts of her mesh.

During jury deliberations, the jury reheard testimony from both Gross and Benson. During the trial, which began Jan. 10, jurors also heard from 11 company witnesses and several experts on each side.

Johnson & Johnson shares fell 2 cents to $76.23 at 12:40 p.m. in New York Stock Exchange trading.

The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).

To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

Accessing justice is a high barrier for patients who experience failed implanted medical devices. they are hurt and medically impoverished. The surgeons are not legally required to report "adverse events" to the FDA unless there is a fatality.  Registry of the devices (if there is any) is held in a proprietary silo and data of implants success/failure is obscured for patients making life-changing decisions.  The monumental failure of Johnson & Johnson both for DePuy MoM (metal on metal hips) and Ethicon surgical mesh were preventable if marketing had not led science.  Why is this not criminal?  It is defrauding the government because taxpayers absorb the expen$ive accountability that the industry does not. FiDA Failed Implant Device Allicance  Joleen Chambers