littlemissmartypants
littlemissmartypants's JournalPlease consider supporting this cause, MDSA17 HR2164
#MDSA17 HR2164ASHES
Advocating Safety in Healthcare, E-Sisters
Medical Device Safety Act 2017
Introduced April 26, 2017
H.R.2164
There are currently 157 Class III medical devices on the market protected by preemption. Preemption is the rule of law that if the federal government through Congress has enacted legislation on a subject matter it shall be controlling over state laws. Riegel v. Medtronic, Inc., (2008), was a United States Supreme Court case in which the Court held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenges the effectiveness or safety of a medical device marketed in a form that received premarket approval (PMA) from the Food and Drug Administration. Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III medical devices are supposed to have the strictest guidelines because they pose the greatest risk. Class III medical devices must follow Class I and II guidelines but must also get premarket approval by the FDA, and a scientific review of the medical device must be made prior to marketing. Class III medical devices normally support or sustain human lives. These devices include implanted pacemakers, heart valves and implanted cerebral simulators to name just a few. Once a Class III device has received PMA, it’s manufacturer is then granted preemption protection, or to put it simply, the manufacturer cannot be held liable for injury or death in court.
We come to you asking for your support of The Medical Device Safety Act 2017 as consumers who have been harmed by some of these devices. Even decades after PMA approval, if a Class III device has been proven ineffective or proven to cause harm, individuals still cannot hold a manufacturer liable for injury. We deserve the same rights as all consumers and patients.
The Medical Device Safety Act 2017 would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.
IN THE HOUSE OF REPRESENTATIVES
Mr. FITZPATRICK (for himself, Ms. DELAURO, and Ms. SLAUGHTER) introduced the following bill; which was referred to the Committee on April 26, 2017
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Medical Device Safety Act’’.
SEC. 2. LIABILITY UNDER STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES.
(a) AMENDMENT.—Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by adding at the end the following:
‘‘(c) NO EFFECT ON LIABILITY UNDER STATE LAW.—Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.’’.
(b) EFFECTIVE DATE; APPLICABILITY.—The amendment made by subsection (a) shall—
(1) take effect as if included in the enactment of the Medical Device Amendments of 1976 (Public Law 94–295); and
(2) apply to any civil action pending or filed on or after the date of enactment of this Act.
*Snip. List of unregulated medical devices. Snip.*
We need your help to get support for this bill from Members of Congress and get it passed. The more Members of Congress get calls and emails about something, the more they listen!
In short, the Medical Device Safety Act (H.R. 2164) will allow consumers harmed by Class III Medical Devices to seek justice in a court of law.
It is simple to help...
This link will automatically email ALL of your reps asking for their support of The Medical Device Safety Act for FREE!
EVERYONE PLEASE go to this link and fill out a request to send this letter to your reps! It is quick, simple and free!!!! You can CHOOSE to pay $3 to have a hand written letter delivered if you wish, but not necessary!!!
https://www.ashesnonprofit.com/mdsa17-hr2164
List of medical devices at the link.
Thank you for considering supporting this cause.
#Esisters at #Essureproblems.
https://essureproblems.webs.com/side-effects-of-essure
On Facebook at https://www.facebook.com/groups/Essureproblems/?ref=share
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Dorothy Arzner, First Female Director in Hollywood Studio System
Dorothy Arzner, First Female Director in Hollywood Studio System
Dorothy Arzner (1897-1979) was a Hollywood film director.
A woman director was a rarity in the early days of filmmaking. She directed films from 1926-1943 and amassed a considerable body of work. Arzner was also the first woman to become a member of the Directors Guild of America.
How did she get started, and how has she so quickly been forgotten?
Dorothy Arzner’s Early Years
Arzner was born in San Francisco. Her family moved to Los Angeles where her father opened a restaurant that attracted a Hollywood clientele. During high school, Dorothy sometimes waited tables for her dad, and she became accustomed to being around celebrities.
After high school, she enrolled in the pre-med program at the University of Southern California. She was a student there when the U.S. entered World War I. Like many of her generation, she wanted to help and went overseas where she was assigned to drive ambulances. This experience must have dampened her enthusiasm for medicine, as she came home wanting to work at a film studio. Through her father, she contacted William C. DeMille about a job. He placed her as a stenographer at Famous Players-Lasky Corporation, which later became Paramount Pictures.
The Studio System in Hollywood
In the 1920s, films were still a very new form of entertainment. Americans who could afford to go to the movie theaters couldn’t get enough of them. Theaters across the country would happily use up to four hours of new material every single week to keep audiences coming back. This meant that the studios had to churn out both short films and long ones as quickly as they could. Actors and craftspeople were employed by the studios, and they were all rotated around depending on what was being filmed on any given day.
While each studio sponsored a few big budget films where directors could take their time in filming, most of the focus of the studio work was on films that could be shot and gotten into the film can quickly.
Much more at the link.
https://americacomesalive.com/2016/03/08/dorothy-arzner-first-female-director-hollywood-studio-system/
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Happy Women's History Month!
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Study: Memories of music cannot be lost to Alzheimer's and dementia
Study: Memories of music cannot be lost to Alzheimer's and dementia
The part of your brain responsible for ASMR catalogs music, and appears to be a stronghold against Alzheimer's and dementia.
NED DYMOKE
29 April, 2018
Some music inspires you to move your feet, some inspires you to get out there and change the world. In any case, and to move hurriedly on to the point of this article, it's fair to say that music moves people in special ways.
If you're especially into a piece of music, your brain does something called Autonomous Sensory Meridian Response (ASMR), which feels to you like a tingling in your brain or scalp. It's nature's own little "buzz", a natural reward, that is described by some as a "head orgasm". Some even think that it explains why people go to church, for example, "feeling the Lord move through you", but that's another article for another time.
Turns out that ASMR is pretty special. According to a recently published study in The Journal of Prevention of Alzheimer's Disease (catchy name!), the part of your brain responsible for ASMR doesn't get lost to Alzheimer's. Alzheimer's tends to put people into layers of confusion, and the study confirms that music can sometimes actually lift people out of the Alzheimer's haze and bring them back to (at least a semblance of) normality... if only for a short while. ASMR is powerful stuff!
This phenomenon has been observed several times but rarely studied properly. One of the most famous examples of this is the story of Henry, who comes out of dementia while listening to songs from his youth:
Brief conclusion at the link.
https://bigthink.com/news/ever-get-the-tingles-from-listening-to-good-music-that-part-of-your-brain-will-never-get-lost-to-alzheimers
NC teachers who carry guns in schools would get pay raises under new bill
NC teachers who carry guns in schools would get pay raises under new bill
BY T. KEUNG HUI
MARCH 06, 2019 02:38 PM,
UPDATED MARCH 07, 2019 11:06 AM
RALEIGH
There’s a new push to allow North Carolina teachers to carry guns in school that some state lawmakers think has a chance of being approved this year.
The School Security Act of 2019, filed Wednesday, would boost the salaries of teachers who underwent specialized police training to carry firearms on campus. The same bill was filed last year and died in committee, but Sen. Jerry Tillman, one of the new sponsors of Senate Bill 192, said that the climate has changed to give the legislation more support this year.
“This is an idea whose time has come,” said Tillman, the Senate majority whip and a Republican from Randolph County. “With the heightened awareness of the legislature, I believe this bill will see success.”
The bill’s two other primary sponsors are Republican senators Ralph Hise and Warren Daniel.
More, including video, at the link.
https://www.newsobserver.com/news/politics-government/article227180999.html
Poland Unveils Glow-In-The-Dark Bicycle Path That Is Charged By The Sun
Poland Unveils Glow-In-The-Dark Bicycle Path That Is Charged By The Sun
Cycling is one of the most eco-friendly ways to travel, and thanks to this solar-powered bike lane that glows in the dark, it just got even more so. If you ever plan on visiting Poland, be sure to bring your bike. That way you won’t miss out on trekking the luminous bike path which is completely self-sustaining, as it’s charged by the sun.
The Starry Night bike path is illuminated by phosphor, a synthetic material that lights up after it’s been charged by the sun. This improves the aesthetic appeal and safety of the path.
Located near Lidzbark Warminski, the bike path is illuminated by phosphor, a synthetic material that lights up after it’s been charged by the sun. The starry-looking path was inspired by Studio Roosegaarde and was created by TPA Instytut Badań Technicznych Sp. z o.o,
Said Igor Ruttmar, president of TPA Sp. z o.o., “The material we used for the track gives light for over ten hours. That means the road can radiate throughout the whole night and reaccumulate light the following day”
More at the link.
http://expand-your-consciousness.com/poland-unveils-glow-in-the-dark-bicycle-path-that-is-charged-by-the-sun/
It Took Two Months and Nearly a Million Dollars to Save an Unvaccinated 6-Year-Old From Tetanus
It Took Two Months and Nearly a Million Dollars to Save an Unvaccinated 6-Year-Old From Tetanus
A new case report from the Centers for Disease Control released Thursday starkly highlights the costs of not vaccinating children. It details an unvaccinated 6-year-old boy’s encounter with tetanus—and the hugely expensive, two-month-long effort it took to save his life.
Tetanus is caused by the namesake bacteria Clostridium tetani. More accurately, it’s what happens when the soil-loving C. tetani gets into your body—usually through an open cut—and spews out an extremely potent toxin. This toxin can quickly paralyze and send your muscles into constant spasms, beginning with the jaw (if you know anything about tetanus, it’s probably that it causes lockjaw). These spasms can then spread to the chest, back, and gut, leading to painful fractures, problems breathing, and even the complete loss of bowel control. It’s a brutal disease, one that can take months to fully recover from. Even with treatment, 10 percent of victims ultimately die.
Thankfully, we’ve had a working vaccine for tetanus since the 1920s, and vaccination has virtually eliminated the disease in countries with decent healthcare. Most every person in the U.S. is fully vaccinated for tetanus by the time they enter school, with the first of five shots happening at the age of 2 months (booster shots every 10 years afterward are recommended). Unfortunately, that wasn’t the case for the unnamed child in this report, since his family had chosen to not vaccinate him for any condition.
According to the authors, the 6-year-old boy from Oregon had gotten a forehead scrape while playing outside on a farm sometime in 2017. The wound was cleaned and sutured at home, but six days later the boy began experiencing lockjaw and muscle spasms. He then started arching his back and neck involuntarily and eventually could barely breathe, prompting his family to call for help.
More info at the link.
https://gizmodo.com/it-took-two-months-and-nearly-a-million-dollars-to-save-1833137421
The Safety Dance, Men Without Hats
Fifth arrest made on election-related crimes connected to NC-9 investigation
Source: WBTV
Fifth arrest made on election-related crimes connected to NC-9 investigation
By WBTV Web Staff | March 4, 2019 at 4:34 PM EST - Updated March 7 at 8:04 PM
NEW HANOVER COUNTY, NC (WBTV) - Five people have now been arrested on election-related crimes connected to the investigation into election fraud in North Carolina’s 9th District.
On Thursday, the NC State Bureau of Investigation said Rebecca D. Thompson was arrested after she turned herself in at the Bladen County Sheriff’s Office. She is charged with conspiracy to commit felonious obstruction of justice and possession of absentee ballot.
Caitlyn Croom was arrested Sunday around 11:30 a.m. in New Hanover County. Then on Tuesday, Tonia Marie Gordon and Matthew Monroe Mathis were also taken into custody and each was charged with felonious obstruction of justice and possession of an absentee ballot. Mathis was also charged with falsely signing certification on an absentee ballot.
Croom, Gordon and Mathis are three of four individuals who were indicted with McCrae Dowless for charges of illegally collecting absentee ballots related to the ongoing investigation into absentee ballot irregularities in Bladen County during the 2016 General Election and the 2018 Primary Election.
More at link.
Read more: http://www.wbtv.com/2019/03/06/fourth-arrest-made-election-related-crimes-connected-nc-investigation/
The situation in District 9 is a developing story. This is not a duplicate as you can see the post contains new information. It will be updated as appropriate.
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