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Ethicon Media Monitoring 6/13/2018
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Martinez v Boston Scientific Plaintiff Opens
Jun 12, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
During the opening arguments, an attorney for Ms. Martinez says the company knew its products would cause the pain suffered by Ms. Martinez. -
4 Reasons Boston Scientific Is A Screaming Buy
Jun 12, 2018 | Forbes
By Peter Cohan
Boston Scientific shares could soon be scooped up by an acquirer. And even if they're not, the Marlborough, Mass.-based medical device maker's stock is on a roll. -
‘Gray Tsunami’: More seniors filling homeless shelters
Jun 12, 2018 | Q13 Fox News
By Katey Rusch
...To add to the stress, shortly after her husband’s death, Flocchini became ill, unable to work. Flocchini is one of the thousands injured by Boston Scientific’s vaginal mesh implants... -
Menopause myths and NICE news for HRT treatment
Jun 13, 2018 | New Zealand Doctor
By Keira Stephenson
...Surgical mesh is a “shameful” recent example. ... Current low dose vaginaloestrogen preparations can be used for a long time for genitourinary symptoms.
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Martinez v Boston Scientific Plaintiff Opens
Jun 12, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
During the opening arguments, an attorney for Ms. Martinez says the company knew its products would cause the pain suffered by Ms. Martinez.
Jim Waldenberger of Kline Specter, one of two attorneys representing Ana and Jose Martinez of Nevada, conducted the opening statement to the group of 15 jurors May 30,in a Woburn, Mass courtroom. The trial accuses Boston Scientific of launching two defectives meshes to the market- the Pinnacle Pelvic Floor Repair system and the Obtryx used to treat incontinence.
MR. WALDENBERGER OPEN
Since Ms. Martinez was implanted with both meshes in December 2010, “they have left her vagina scarred and deformed, which has basically created two problems for Ana,” said Waldenberger in his opening statement to jurors.
That has led to pain with sexual intercourse and with groin pain. She will have these problems for the rest of her life and Ana now has involuntary leaking of urine, he said. Both of these problems are permanent and were caused by the Pinnacle and Obtryx products.
The material that makes the meshes is called polypropylene and it’s heavyweight and not adaptable to a woman’s body, said Waldenberger. Boston Scientific didn’t evaluate, test or determine in any way how these products would react in a woman’s body. They launched them on the market to be competitive with their competitors, jurors were told.
“I want you to ask yourselves, when you hear the evidence, as to whether or not Boston Scientific took responsibility to provide a safe product for the people who need help with the conditions that I’ve just described.”
Martinez had a cystocele, a form of pelvic organ prolapse, treated with the Pinnacle, used for pelvic organ prolapse (POP). And she had stress urinary incontinence, treated with the Obtryx.
Boston Scientific bought its raw polypropylene (PP) material from the Chevron Phillips petroleum company. The raw material came with a warning:
“Do not use this Chevron Phillips Chemical Company LP material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
Urologist, Dr. Michael Margolis will appear at trial, so will Dr. Scott Guelcher, a biomedical engineer. He plans to tell the jury that PP is not suitable for implantation in the human body, it is suitable for carpet backing and automotive products. When implanted in the body, it recognizes PP as a foreign substance and the body attacks it. Excessive scarring then occurs which contracts the mesh causing it to tighten, become brittle and hardened taking nerves with it that cause pain.
The foreign body reaction in Martinez’ body from the Obtryx PP implant, caused mesh shrinkage and obstructed her urethra. Pinnacle caused chronic infections, vaginal scarring and erosion into the vaginal wall. The mesh had to be clipped away. It eroded again, the jury was told.
With chronic infections and discharge she underwent a surgery by Dr. Sheldon Freedman in October 2011 to cut out as much Pinnacle mesh as he could. Unfortunately, he had to remove part of her vagina as well, causing it to be disfigured. It’s called a vaginectomy.
Waldenberger continues reminding the jurors there were no clinical trials for these products. Instead, they were rushed to the market to keep up with competitors, even as some within the company, internal documents show, suggested testing should be conducted to see what effects the mesh has in a woman’s body.
The testing that did occur was on rats in the early 2000s.
Boston Scientific took the polypropylene (PP) material, extracted it down to a liquid and ran lab tests, by injecting the liquid into mice to look for cancer; they injected it into guinea pigs to see if they were allergic; and injected into other mice to see if there were mutations. Mesh was implanted under the belly skin of rabbits. The testing took days to weeks.
Even without the testing, “They did know of the dangers of polypropylene products,” he said.
BOSTON SCIENTIFIC CHINESE RESIN
Numerous reports have surfaced about Boston Scientific (BSC) and its search for new PP resin after its supplier said it would no longer sell PP to BSC. Most recently, 60 Minutes outlined the plan to smuggle counterfeit PP from China even though the company could not verify its authenticity.
Since late 2012, it is presumed that BSC transvaginal meshes are made from the PP that came from China. Because she was implanted earlier, the Chinese mesh question will not be entered into this trial.
BOSTON SCIENTIFIC MESH LAWSUIT SETTLEMENTS
One year ago, Boston Scientific announced it planned to settle more than 37,000 cases without admitting fault. A class action lawsuit filed in Charleston, West Virginia, alleged BSC was involved in racketeering for the smuggling of PP resin and filed a RICO (Racketeer Influenced and Corrupt Organizations Act) claim.
Those charges of which are usually reserved for organized criminal activity. The class action, headed by Teresa Stevens is reported to be in settlement discussions through Mostyn Law of Houston.
STILL ON THE MARKET
Boston Scientific had 26,000 product liability claims filed in multidistrict litigation in Charleston, WV, the second highest number behind Ethicon (Johnson & Johnson). Still on the market are its incontinence devices, Advantage Fit, Advantage, Lynx, Obtryx II and Solyx Single incision sling.
Also BSC is one of the few companies still selling products for pelvic organ prolapse since they now must go through the more rigorous premarket approval. They include the Uphold Lite, Upsylon Y mesh and Xenform Soft Tissue Repair Matrix.
The first transvaginal mesh marketed in the U.S. in 1999 was Boston Scientific’s ProteGen TVM, though it was recalled by the FDA three years later when it failed and led to injuries.
In 2014 and 2015, the company lost two jury trials with eight plaintiffs (4 each) totaling $27 million (Pinnacle trial) and $19 million in the Obtryx trial.
https://www.meshmedicaldevicenewsdesk.com/martinez-v-boston-scientific-plaintiff-opens/
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4 Reasons Boston Scientific Is A Screaming Buy
Jun 12, 2018 | Forbes
By Peter Cohan
Boston Scientific shares could soon be scooped up by an acquirer. And even if they're not, the Marlborough, Mass.-based medical device maker's stock is on a roll.
Should you go along for the ride? I see four reasons you should. (I have no financial interest in the securities mentioned in this post).
The acquirer could be medical device rival, Stryker. On June 11, the Wall Street Journal reported that medical device marker Boston Scientific had received a takeover approach from Kalamazoo, Mich.-based Stryker – a $65 billion (June 11 stock market capitalization) maker of “hip and knee replacements, endoscopy systems, operating room equipment, embolic coils, and spinal devices.”
Trading in both stocks was halted, leaving Boston Scientific’s stock market capitalization at around $47.4 billion, 7.4% above its stock market value on June 8. Even if this deal does not go through, it could attract other bidders.
Stryker and Boston Scientific declined to comment.
Founded in 1979, Boston Scientific “produces less-invasive medical devices that are inserted into the human body through small openings or cuts. It manufactures products for use in angioplasty, blood clot filtration, cardiac rhythm management, catheter-directed ultrasound imaging, upper gastrointestinal tract tests, and treatment of incontinence.”
Ironically, up until the report of a possible Stryker deal, one of the most important moments in Boston Scientific’s history was its 2006 acquisition of Indianapolis, Ind.-based medical device maker Guidant. In early January 2006, Boston Scientific outbid Johnson & Johnson by $9 a share to clinch the deal for Guidant.
This was a famously bad deal. According to the Wall Street Journal, between 2006 and 2012, Boston Scientific took $9 billion in write-downs, mostly related to the Guidant acquisition, and its stock lost nearly 85% of its value — from $32.30 before the announcement to about $5 in July 2010. In February 2015, Boston Scientific paid $600 million to J&J, which sued Guidant for $7 billion in damages for allegedly breaching its merger deal with J&J.
And that’s not all. In May 2018, 60 Minutes reported that Boston Scientific had been the target of at least 48,000 lawsuits from over 100,000 women alleging that the plastic strip inflicts on its vaginal mesh devices causes serious pain and injury.
In a statement, Boston Scientific said that nearly 1 million women have been “successfully treated” with the mesh and that the plastic is safe.
Nevertheless, Boston Scientific shareholders who bought at its low point have been rewarded – its shares soared 540% from that July 2010 low through June 11 – but that day’s $32 a share was still 29% below its all-time high of $45 on May 31, 2004.
Despite these problems, I see four reasons why Boston Scientific stock could rise.
1. A deal with Stryker would open up attractive markets
Let's say Boston Scientific merged with Stryker — would the combined company be better off? To analyze that question, I looked at whether it passes the four tests for successful acquisitions about which I wrote in my 2017 book, Disciplined Growth Strategies.
The deal passes the first test. How so?
Boston Scientific competes in several large, fast-growing markets such as the coronary stents and pacemakers. The stent market is expected to grow at a 7.6% annual rate to $10.31 billion in 2022, according to Market Research Engine. Grand View Research expects the pacemaker market to reach $10.3 billion by 2025, growing at a 7.2% compound annual growth rate.
2. The combined company could gain market share
Boston Scientific and Stryker have very little overlap in their product lines. While Stryker makes and sells parts for knee and hip replacements, Boston Scientific's products include stents and pacemakers.
But there is some overlap – they both make spinal cord stimulators, which are implantable devices used to treat chronic pain.
A deal could allow the two companies to reduce their overhead costs and compete with Medtronic, a leading medical device maker with a $117.3 billion market capitalization.
Debbie S. Wang, Morningstar Senior Equity Analyst, believes that this deal would help Stryker sell more. As she wrote,
The potential combination would allow Stryker access to the faster-growing areas of cardiovascular, structural heart, and neuromodulation. Generally, there are more targets in the cardiac markets and pools of undertreated patients, and it is also typically easier to conduct clinical trials that demonstrate the value of those innovations, compared with [the mature] orthopedic markets [in which Stryker competes].
3. Takeover price is likely to be higher than current Boston Scientific value
As for the final two questions, it’s too early to know whether Stryker could justify the price premium it pays to control Boston Scientific or whether Stryker can integrate Boston Scientific smoothly.
But regardless of those answers, for a deal to close, the price will need to rise. Boston Scientific's stock traded up 7.4% on the deal rumors, but unless the offer is at least 30% above its recent market value, it won't close according to JP Morgan analyst Robert Marcus.
4. Boston Scientific CEO has been presiding over rapid stock price growth
What if a deal does not go through? Its new CEO seems to be doing a nice job of boosting its stock.
Since Michael Mahoney became CEO in November 2012, Boston Scientific has been on a roll. In the five years ending June 11, its stock has risen a whopping 271%, its revenues have grown at a 4.5% annual rate to about $9 billion in 2017, and it has become profitable – 2017 net income was $100 million – a razor thin net profit margin of 1.1%.
Recent growth and profitability have accelerated. Its first quarter 2018, revenues were up 10.1% to $2.38 billion — $40 million above the Zacks Consensus Estimate. Its adjusted EPS popped 13.8% to 33 cents -- beating by two cents the Zacks Consensus Estimate.
Risk averse investors might take a chance that the deal falls through and other suitors do not emerge. If that happens, the stock is likely to fall back — creating a more attractive entry point.
https://www.forbes.com/sites/petercohan/2018/06/12/4-reasons-boston-scientific-is-a-screaming-buy/#70fd753b3e58
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‘Gray Tsunami’: More seniors filling homeless shelters
Jun 12, 2018 | Q13 Fox News
By Katey Rusch
“She’s just my baby, yeah." That's the way Tammy Flocchini describes her car. It’s her “baby” because it is her most prized possession, her temporary home when she became homeless in 2016.
A resident at the Everett Gospel Mission, Flocchini is part of the region’s growing homeless population, specifically a segment that is growing: the elderly. In this case, shelter managers say, the group is anyone age 51 and older.
According to the National Alliance to End Homelessness, in 2008 seniors made up 22 percent of the national population. In 2016, that number jumped to 28 percent, and as the Baby Boomer population gets older, those numbers are only expected to grow.
Typically homeless seniors do not fit the overall homeless stereotype. Most are not mentally ill or dealing with addiction. So how did they become homeless?
For Flocchini, it all started in 2013. She and her husband were living in the Tri-Cities. At age 51, she was working at Macy's. The couple was working to pay off their mobile home, just starting to think about retirement but then, doctors diagnosed her husband with cancer. In July 2015, Flocchini’s husband passed away.
“There wasn’t any time to grieve, one or the other,” said Flocchini. “Everything caved in.”
To add to the stress, shortly after her husband’s death, Flocchini became ill, unable to work. Flocchini is one of the thousands injured by Boston Scientific’s vaginal mesh implants.
“They said it would change our lives and they weren’t kidding,” said Flocchini.
Incapable of working, there was no money coming. The 54-year-old was still too young to collect her or her husband’s Social Security benefit. Her savings quickly drained. She lost her home and most of her belongings. All that remains is a few items in the trunk of her car.
“Losing things that are irreplaceable, priceless things that my husband made, they’re memories and little bit by little bit. It’s hard,” said Flocchini.
In 2016, Flocchini drove to Seattle to be close to her doctors and began living in her car, confused and angry.
“How the hell did I get here? How did I end up here? I’ve done everything possible not to,” said Flocchini.
It would prove to be one of the most challenging moments of Flocchini’s life. At a time when she hoped to be settling down with her husband, thinking about her grandchildren, her retirement, instead she was homeless and depressed. She admits she considered taking her own life.
“I got to that point because slowly I was having a breakdown and didn’t know it,” said Flocchini. “What was the point of going on anymore even though I know it’s the biggest sin, even though I know what it does when you’re left behind.”
But then Flocchini got a call from the Everett Gospel Mission, a bed had opened up, and the spot was hers if she wanted it. She took it.
“Without a home but yet this is my home for now,” said Flocchini.
Soon Flocchini found out she wasn’t alone. Of the 45 adult women at the shelter, 20 percent are over 55. Sylvia Anderson, CEO of the Everett Gospel Mission, says it’s happening everywhere.
“In the last year I visited about 15 different missions, and I have seen this graying population of folks in shelters all across the nation,” said Anderson.
It’s part of what is known as the “gray tsunami.”
“The stereotype is people that made bad choices, that they’re on drugs or alcohol or they have significant mental health (problems), but the other story is simply people who have outlived their money,” Anderson said of the elderly homeless population in her shelter.
Many are banking on a significant Social Security payout, but when they get the check, it’s a reality check. On average, the women here at the shelter get less than $750 per month.
It’s even harder for people between 50 and 61. They’re too old to get hired but too young to receive their Social Security benefit. Rose Zahl falls into this category.
“I don’t think it’s something that we plan for,” said Zahl.
She was living in Marysville with her husband and daughter when her husband got cancer and died. She lived off her husband’s death benefit and savings for five years. Then in April 2016, her rent jumped up by $300.
“It was more than what I could pay,” said Zahl. “We did try to find another place, but we weren’t successful in her school district, and she really didn’t want to change.”
At that point, Zahl and her youngest daughter moved into her car.
“It’s really hard,” said Zahl. “Where do you park it? It’s really hard.”
Zahl has a degree from the University of Washington. She was never homeless before and never imagined this is where she’d be at 61.
“We tried to have things pretty much ready for it, just didn’t turn out that way,” said Zahl.
Zahl knows she doesn’t fit the homeless stereotype. Strangers have told her many times before, to which she gives this reply.
“What does a homeless person look like?” said Zahl. “It’s not always somebody who’s in rags or under the bridge, so to speak.”
Flocchini and Zahl hope their stories show people that homelessness can happen to anyone, no matter a person’s age or education level.
“I don’t’ have one person in this shelter who thought this would happen to them and I don’t care what age they are. I don’t have one,” said Anderson.
But yet, they all ended up here. So we asked the women, what advice they have to younger versions of themselves. They both said the same thing: Save.
If you don’t, Anderson warns that you could find yourself where no one wants to be at 55, aging and homeless.
“You work hard your whole life, and then you retire to poverty,” said Anderson.
http://q13fox.com/2018/06/12/gray-tsunami-more-seniors-filling-homeless-shelters/
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Menopause myths and NICE news for HRT treatment
Jun 13, 2018 | New Zealand Doctor
By Keira Stephenson
New medicines, lacking the proper research often follow a meteoric rise, touted as the answer to all problems...
...Surgical mesh is a “shameful” recent example. ... Current low dose vaginaloestrogen preparations can be used for a long time for genitourinary symptoms.
Access to full text unavailable – subscription required. For full story: https://www.nzdoctor.co.nz/article/news/menopause-myths-and-nice-news-hrt-treatment
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