J&J Accused of Criminal Behavior: Pelvic Surgical Mesh

Protest Targets J&J CEO on Day of Annual Shareholder Meeting

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

BREAKING NEWS! MDND reports $100M verdict

Jury Awards Plaintiff $100 Million in Boston Scientific Pelvic Mesh Trial

May 28th, 2015 | By Jane Akre (FiDA highlight)

$100 million in damages.

That is the amount a Delaware jury today awarded to mesh injured woman Deborah Barba. The amount includes $25 million in compensatory and $75 million in punitive damages, established to send a message to the company.

The 51-year-old from Newark, Delaware, sued manufacturer Boston Scientific for her permanent and serious injuries caused by the company’s Advantage Fit and Pinnacle transvaginal meshes.  She was implanted in 2009 and has suffered significant complications and endured two surgeries that did not fully remove the devices.

“While we are extremely pleased with this verdict and the relief we hope it will bring to the Barbas for Deborah’s unspeakable suffering, we also hope Boston Scientific and other mesh manufacturers take note of this verdict and resolve all pending cases swiftly. Deborah’s case will hopefully bring more awareness of mesh issues,s however, no woman and her loved ones should have to endure the stress of going to trial and baring their souls publicly to achieve justice,” said Barba’s attorney Fidelma Fitzpatrick of the Motley Rice law firm.

The jury found Boston Scientific was negligent in its design and manufacture of the Pinnacle and Advantage Fit devices and that the warnings were insufficient to unsuspecting doctors and their patients.

“I am thankful for the jury’s verdict and hope my story can help other women who are suffering from mesh complications to receive the resolution they deserve,” said Deborah Barba. “While difficult to share, I hope my case demonstrates to all mesh manufacturers the dangers of their products and the justice they owe victims.”

The case is Deborah Barba v. Boston Scientific Corporation, Superior Court of the State of Delaware in and for New Castle County, C.A. No. N11C-08-050 MMJ.

http://meshmedicaldevicenewsdesk.com/jury-awards-plaintiff-100-million-in-boston-scientific-pelvic-mesh-trial#comment-519041
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Boston Scientific Told to Pay $100 Million Over Mesh

Jeff Feeley, May 28, 2015  (FiDA highlight)

Boston Scientific Corp. must pay $100 million to a Delaware woman who blamed the company’s vaginal-mesh inserts for leaving her in constant pain and unable to have sex, in the first verdict after the company agreed to begin settling cases over the devices, and the biggest yet.

A state-court jury in Delaware found Thursday that Boston Scientific’s Pinnacle and Advantage Fit inserts, built to buttress sagging organs and treat incontinence in women, were defectively designed and company executives hid the flaws from Deborah Barba.

The 51-year-old former bank teller contends the inserts eroded once they were implanted, leaving her with a scarred vagina and a host of medical problems. The verdict is the largest so far against Boston Scientific over its vaginal-mesh inserts. It eclipsed a $73 million award last year to a Texas woman who blamed the company’s Obtryx sling for her injuries.

The jury also found Boston Scientific engaged in fraud by failing to alert doctors to the devices’ faulty design. It awarded $25 million in compensatory damages and hit the company with a $75 million punitive-damages award.

The vaginal-mesh verdict is also the first since Marlborough, Massachusetts-based Boston Scientific agreed last month to pay $119 million to resolve about 3,000 lawsuits over the devices in the first settlements of claims the inserts damaged women’s organs and made sexual intercourse painful.

Appeal Planned

Kelly Leadem, a Boston Scientific spokeswoman, said the company disputes the conclusion that the inserts were flawed and caused Barba’s injuries.

“We disagree with the jury’s finding and intend to appeal based on the strength of our evidence,” she said in an e-mail.

The verdict is surprising because it came in Delaware, the most corporate-friendly state in the nation, Erik Gordon, a professor at the University of Michigan’s business and law schools who teaches classes on how drugs and medical devices are developed and regulated, said by e-mail.

“Corporation-friendly Delaware juries rarely award punitive damages,” Gordon said. “A good portion of Delaware’s economy is driven by its business of domiciling most of the country’s largest corporations.”

Delaware, the corporate home to more than half of the U.S.’s publicly traded companies and 63 percent of Fortune 500 firms, had more than 1 million legal entities incorporated in the 900,000-resident state by 2012, officials said.

‘Loudly, Clearly’

“The jury spoke loudly and clearly that Boston Scientific’s defective devices injured Mrs. Barba and many other women and they should step and take responsibility for causing that harm,” said Fred Thompson, one of her lawyers.

The U.S. Food and Drug Administration ordered Boston Scientific, Johnson & Johnson and more than 30 other vaginal-implant makers in 2012 to study rates of organ damage and complications linked to the devices after the companies faced a wave of lawsuits over them.

Women such as Barba allege that inserts produced by Boston Scientific and other companies are made of substandard materials and shrink once they are implanted, causing organ damage and persistent pain. J&J moved in June 2012 to pull four lines of inserts off the market.

Many of the more than 70,000 mesh-insert cases have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Others have been filed in state courts in Delaware, New Jersey, Missouri, Texas and California.

Goodwin has been pushing manufacturers to consider settling the cases before they face billions in jury awards.

Settlement Talks

Boston Scientific, C.R. Bard Inc. and other makers of vaginal inserts had talks two years ago about creating a global settlement of cases over the devices, according to people familiar with the discussions. J&J, which refused to participate in 2013 settlement talks, has now begun to settle some cases.

While Boston Scientific and Bard couldn’t agree on an overarching settlement program, both companies have begun to settle some individual suits and some lawyers’ inventories of cases.

Boston Scientific agreed to pay the $119 million to resolve nearly 3,000 cases collected by a group of plaintiffs’ lawyers led by Houston litigator David Matthews in April. The settlement provided an average payout of about $40,000 per case.

The Delaware case is Barba v. Boston Scientific Corp., CA No. 11C-08-050-MMJ, Superior Court of Delaware (Wilmington).

http://www.bloomberg.com/news/articles/2015-05-28/boston-scientific-ordered-to-pay-100-million-over-vaginal-mesh

Surgical mesh and medical destitution: a medical device failure.

A tangled web: Lakewood woman creates a nonprofit towarn others about medical mesh

1

26 May 2014

by Brittany Nunn

Photo by Hal Samples

Lakewood neighbor Aaron Horton just wants her mom back.

It’s the little things — like going out for sushi, window-shopping, getting facials or manicures, and chatting about art — that Horton misses the most.

“I miss my mom,” Horton says. “I miss being able to pick up the phone and say, ‘Hey, I just saw this purse and it made me think about you,’ or ‘I just saw this movie; let me tell you about it.’ ”

Although Horton’s mom is still alive, in many ways Horton has been forced to prematurely grieve the loss of the mother she once had.

Horton’s mom, who asked that we not reveal her identity, is in a constant state of excruciating pain — at times worse than anything she experienced during childbirth — due to an injury caused by a medical device called trans-vaginal mesh.

The pain wasn’t always so extreme.

Originally, Horton’s mother suffered from urinary incontinence (the loss of bladder control) and pelvic organ prolapse (a condition in which the bladder and the bowels slip out through the vaginal canal). To fix the problem, doctors used trans-vaginal mesh, which essentially is a small hammock made of plastic mesh, to hold her organs in place.

She was told the operation would be minimally invasive, but she knew something was wrong as soon as she woke up from the surgery. Her surgeon told her she simply needed time to heal.

The pain was localized at first, occurring only in her pelvic region, but it was unrelenting. For months, doctors dismissed the pain. Eventually it began to spread to every part of her body — sometimes it was sharp, sometimes it was dull, sometimes it was throbbing, and sometimes it was all three. She talked with more doctors, but no one could give her any answers. She tried physical therapy and nerve blocks, but nothing helped.

“My mom was really sick, and she wasn’t getting better,” Horton says.

“Once I realized how sick she was, I got online to see if there were other people, and I realized there’s this whole community of women who have been injured by this medical device.”

Horton wrote what she calls “a hearticle” about her experience of watching her mom suffer and not being able to help, and it was published on journalist Jane Akre’s website, Mesh Medical Device News Desk, in July 2013. Horton received an outpouring of support in the comments section.

“They had all gone through the same thing and had the same questions,” she explains. “I thought I was going to get some help, and then it just kind of confirmed that there was no help available.”

It spurred Horton to dig deeper, to find some answers for her mom, as well as for the many other suffering women.

She discovered that doctors have used medical mesh in more than 1.5 million women to fix organ prolapse, urinary incontinence or hernia, and they continue to implant it in some 70,000 to 90,000 women every year.

Most of the women are post-menopausal baby boomers who have had children.

Although many women are happy with the implant, thousands report suffering due to injury caused by the device.

Horton formed a nonprofit called The Mesh Warrior Foundation For the Injured, which she operates from her Lakewood home. She works full-time doing research, talking with doctors and surgeons, raising awareness about the mesh-related injuries, and advocating for the injured.

What Horton found during her research shocked her.

There are six manufacturers of the product, and the largest one is Johnson & Johnson, through the medical unit of its company, Ethicon.

Medical mesh is made of propylene plastic, and it was originally used for hernia repair. Then, in early 2000, manufacturers began creating other mesh products, which Horton says were never tested on live humans, only cadavers and dogs.

The U.S. Food and Drug Administration (FDA) approves the products through the 510(k) process, which “clears the device for commercial distribution” without having to go through the entire process, according to the FDA website.

Instead, manufacturers simply have to prove the new product is “at least as safe and effective” as a predicate device of substantial equivalence (SE) that has already been approved by the FDA.

As soon as the FDA rubber-stamps the device, manufacturers are free to start marketing it. Although there are other ways to fix medical issues such as incontinence or pelvic organ prolapse, most of the alternative methods are considered invasive, complicated and expensive. Mesh was marketed as simple and cheap, and the general public became the test subjects, Horton says.

The FDA in 2008 issued a Public Health Notification regarding “serious complications associated with trans-vaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.

The notice states, “The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.”

“My question was: How did this happen to 1.5 million women?” Horton asks. “All the safeguards we have in our society, and we’re supposed to have the best health care in the world and the best access to it.”

Dr. Michael Hibner, the director of the division of surgery and pelvic pain at St. Joseph’s Hospital and Medical Center in Phoenix, has been removing the mesh from women’s bodies for several years.

“I think it’s a very small percentage [of women] that have a serious reaction,” he says. “There are people who are happy with the mesh. The problem is that those who are unhappy with it are really, really unhappy with it.”

Most of the women Hibner sees have pain due to three things: pain from the mesh rubbing against or tugging at the nerves, nerve damage during implant or explant of the mesh and/or a foreign-body reaction to the mesh itself.

Hibner believes manufacturers are largely to blame for the mesh-related injuries.

Hibner says that if the procedure is done right, women shouldn’t have pain or discomfort. The problem, Hibner says, is that manufacturers are selling the device to doctors as a one-size-fits-all device, and it’s being touted as a simple, non-invasive procedure, so the doctors implanting the mesh haven’t been appropriately prepared or trained.

Dr. Greg Vigna, who spent 18 years in the medial industry but now practices law in catastrophic injury in California, is familiar with the trail of broken lives mesh-related injuries leaves behind.
As a doctor, Vigna worked with patients who suffered from pudendal neuralgia, which is chronic pain due to the pudendal nerve, which is located in the pelvis, being entrapped or compressed. Until a few years ago, this was very uncommon.

“This mesh device caused a problem that used to be very rare,” he says. “It’s not rare anymore because mesh has been used so many times.”

Most women do not have the time, resources or the physical wellness needed to go head-to-head with pharmaceutical companies, so they become “medically destitute,” Vigna says. They lose their jobs because they can’t work, they lose their husbands because they can’t have sex, and they lose their families because they’re in so much pain they can’t function normally.

“There’s failure in the medical community, there’s failure in the financial community, and there’s failure in the legal community,” Vigna insists.

At the time of publication there had been 56,999 mesh-related lawsuits filed, according to Vigna, but very few settlements have come down.

At the same time doctors like Hibner are taking the mesh out, hundreds more continue to put it in. Other doctors try to remove mesh, but very few know how to do it correctly, Vigna says.

“For years women were only getting part of the mesh taken out, and that wasn’t helping,” Vigna says. “In fact, that was just making things more complicated for future doctors.”

Most of the women Hibner sees have already had the device extracted but are still experiencing pain, usually because parts of the mesh are still inside the body, pulling at sensitive nerves. He says he believes removing the entire device, all at once, is best.

“I’ve seen women who have clearly gotten better after removing the mesh. But then, there are other ones who didn’t. So I think it depends on the patient. Some have had more injury to the nerves, and others have had less injury to the nerves, so it’s hard to tell.”

Horton and her family are crossing their fingers, hoping Horton’s mother is one of the lucky ones.

Horton’s mother had surgery to have her mesh removed in May, and her family is still waiting to find out if the surgery was successful in lessening or erasing her pain.

“But the truth is, each injury is different,” Horton says. “They don’t know what happens during the explant because it just depends on the woman’s body and the kind of injury.”

In the meantime, Horton continues to research and fill her blog with personal stories and interviews with doctors in hopes of reaching as many women as possible.

“There’s still so many more who don’t know,” Horton says. “That’s what keeps me awake at night.”

To learn more  about Aaron Horton and The Mesh Warrior, visit themeshwarrior.com

- See more at: http://lakewood.advocatemag.com/2014/05/26/medical-mesh-tangled-web/#sthash.m0XaEEZh.dpuf


Comment - FiDA  (retrieve this)
Thank you for this excellent article, Brittany Nunn and Lakewood/East Dallas Advocate!  My advocacy to demand safer and more effective implanted medical devices began 5 years ago when a family member began suffering with a failed implanted device.  What I learned chills me to the bone in the middle of a Dallas summer:  the system is rigged!  Medical device companies have so much clout that our FDA is a mere mirage and there is no "there" there.  Patients are not protected and even the judicial system has been altered to favor the industry and protect the profiteers from accountability.  The mounting patient harm signals "settlements" that do little to stop the carnage.  I blog at Failed Implant Device Alliance and attended FDA Patient Representative training (by invitation).