Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Saturday, May 13, 2017

J&J Accused of Criminal Behavior: Pelvic Surgical Mesh

Women Allegedly Harmed by Pelvic Mesh Express Disappointment with J&J
ARTICLE | MAY 11, 2017 - 9:48PM | BY DAVE SCHATZ   FiDA highlight


MAM co-founder Lisa Mason is seen here during a rally on April 27 outside the State Theatre. Mesh Awareness Movement
NEW BRUNSWICK, NJ–Members of  the Mesh Awareness Movement (MAM) want Johnson & Johnson’s (J&J’s) shareholders “to know they are investing in criminal behavior,” according to a statement.
The group, a grassroots effort to bring awareness to the harmful effects of mesh on the human body, held a rally against J&J in New Brunswick on April 27, during its annual meeting of shareholders. 
MAM has a Facebook group that's grown from about 20 to 700 people in just a year-and-a-half, according to co-founder Tammy Jackson, who said others have contacted her but aren't keen on taking part in social media due to their attorneys' advice.
Jackson said a couple woman in the group were recently offered $189 by the pharma giant to settle their cases, but declined, while five others she knows personally accepted $4,000, and seven received $200,000, in the past six to seven months.
“It’s hard to get people so badly injured to travel across the country and stand all day,” said Jackson, a 50-year-old resident of Kentucky, and former nurse, adding she also brought chairs to the rally for some of the women.
Yet during the hour-plus meeting of shareholders inside the State Theatre, where audio was streamed live on the internet, the women held a protest outside the theatre and say they feel their voices were heard.
Their chants included:
  • “No more mesh…”
  • “Stop the harm, No more profits.”
  • “You are not going to be able to hide from us.”
  • “Profit over lives.”
Jackson has had 17 mesh removal and reconstruction surgeries over the past four years, she said.
“Trying to remove mesh out of your pelvic is like removing rebar out of concrete," said Jackson. "Your bladder is angry."
J&J says "we are nothing more than a 'cost of doing business.' We say, we are a hundred thousand severely and permanently injured people who could just as easily be your wife, mother or sister," continues MAM’s statement.
"It doesn’t matter to [J&J] that they’ll have to spend, for example, $2.5 Billion in Litigation, Verdicts, Penalties and fines because they’ve already made $25.1 Billion,” added the statement.
Jackson’s 10-year-old daughter was interviewed for a documentary about patient safety while in the Garden State with her mother and father for the rally.
She told the producers, “I would say quit making mesh and help my mommy,” according to Jackson, who said many MAM members were also interviewed for the film. 
“Where's the media?” wondered one MAM member during the rally. “They need to tape this -- we should flood the TV stations.”
One journalist, Jane Akre, operates the Mesh Medical Device News Desk (MMDND), and was present for J&J's annual meeting of shareholders on the morning of April 27. 
She thought the presentation to J&J's stock holders was "rehearsed" and highlighted "the health of J&J's stock," as Alex Gorsky, J&J's chief executive officer, repeated the words "sustainable" or "people come first." 
Yet across the street, she writes, via an "orderly, heart-felt display," some 30 women and their families rallied.
But their signs indicated they didn't feel like they came first: “The Johnson & Johnson Credo: ‘Research must be carried on, innovative programs developed and mistakes paid for.' Pay the mesh injured for your mistake!”
“Mr. Alex Gorsky” was targeted by another sign that continued, “The highest form of ignorance is when you reject that which you know nothing about.”
A sign urged Gorsky to “Talk to the mesh injured,” while the message on another read: “#SerialKiller CEO. It’s time for you to go!”
"Each [woman] represents at least 10,000 [pelvic] mesh implanted women who can’t make it to a mesh rally, because they are too sick or broke from fighting to regain their health! And that doesn’t even begin to include the one million hernia mesh implants a year!” wrote Akre.
"All use polypropylene! Some day in the not so distant future, we may come to recognize that this cheap plastic is not an ideal, bio-compatible material for an implant, I believe."
"The legal facts have shown that [J&J] knew these mesh devices were unsafe, but they quickly put them on the market anyway... bypassing proper FDA approval, failing to conduct thorough testing and withholding serious risks and warnings,” continues MAM’s statement.
"Little did I know that [during the shareholders meeting], a Philadelphia jury was delivering the third verdict for a plaintiff in another mesh trial – $20 million, which included $17.5 million in punitive damages!"
http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook
Akre wondered whether J&J might now be considering a "multi-billion dollar global settlement" and whether "fighting mesh-injured women in court" is worth it. 
The pharma giant is facing $34.5 million in punitive damages, plus other amounts awarded by juries in three separate mesh trials in Philadelphia state court, according to reports.
Akre noted that after half a decade of writing reports for MMDND, media coverage of mesh issues is gaining  some traction.
"Internationally, the media is less afraid to report of Pharmaceutical Giants," she writes citing front page stories in Scotland, Australia, New Zealand and the UK, for instance.
Though Akre provided coverage of the April 27 MAM rally, she said very few reporters were there.
“It was a powerful day," said one woman who took part in the event.
"J&J had a line of buses on the other side of the street to block the view of the rally. [The company] rented those buses with money they earned from harming us,” she added, saying that she felt like J&J owned New Brunswick.

J&J did not respond to a request for comment. 

http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook

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