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(c) 2010-2026 Jon L Gelman, All Rights Reserved.

Friday, December 6, 2013

Keeping privacy in focus

Confidentiality has been the hallmark of Workers' Compensation since the inception of the program. Has been challenged federally through the portability act concerning the privacy of medical records. All that reach was bad enough, a data breach from and a governmental site is even worse. It is becoming more than obvious, but the weak financial infrastructure, of the patchwork of worker's Compensation systems for the country are creating serious challenges. Instead of attempting to run 50 different programs throughout the country, it is probably A good idea to start looking inward, and establishing a single solid system that can meet the needs required to run A multibillion-dollar benefit system the rep country and also maintain the confidentiality and privacy that the parties participating in it require. Today's post shared from therepublic.com

Hackers gained access to the personal information of about 26,000 Pennsylvanians who use debit cards to receive jobless and workers' compensation benefits, the Pennsylvania Treasury Department said Thursday.
The incident was part of a wider security breach affecting 465,000 holders of JPMorgan Chase & Co. prepaid cash cards nationwide.
The breach affects only cardholders who used the JPMorgan Chase UCard Center website between mid-July and mid-September, the Treasury Department said. Michael Fusco, a spokesman for JPMorgan, said the bank found no evidence any information was used improperly.
JPMorgan first contacted the Pennsylvania Treasury Department on Tuesday, agency spokesman Gary Tuma said.
JPMorgan has referred the matter to law enforcement and would not explain details of how the breach occurred, the Treasury Department said.
The Pennsylvania agency wants details from JPMorgan Chase about the bank's response to the breach, including an explanation for any delay in notifying it and the additional measures it will undertake to protect against a recurrence.
The department said most of the personal information that might have been viewed includes card numbers, dates of birth, user IDs, email addresses. Information on external bank accounts might have been exposed, as well, if a cardholder completed a transaction to it, the department said.
Cardholders are being contacted by letter with instructions and are being urged by JPMorgan Chase in the meantime to...
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Trickle Down Stagnation

Workers' compensation is dependent the integration of federal benefits in many claims. As the federal government continues to stagnate legislatively, it is difficult for workers' compensation programs to maintain their viability and effectuating a medial social legislative system. Today's post, an editorial, from the New York Times, points out, that the federal government continues big political standoff. Unfortunately, the difficulties facing the federal government in formulating regulations and legislation, Will trickle-down two additional stagnation in the Worker's Compensation programs throughout the nation. Weather this is by design, or an unintentional consequence, the bottom line is that, but Workers' Compensation system Will need to be reformulated before choked out of existence.

Last week, in a fit of fury after they lost the ability to filibuster President Obama’s nominees, several Congressional Republicans threatened to retaliate by slowing things down on Capitol Hill. Democrats “will have trouble in a lot of areas because there’s going to be a lot of anger,” said Senator John McCain, Republican of Arizona, specifically warning that a United Nations disability treaty was now in danger of being rejected for the second time.

It’s hard to see how Republicans could slow things down more than they already have for the last several years. Yes, they can prevent committees from meeting and add days of wasted time to every nomination...

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….
Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.

"Everyone can rise above their circumstance....

"Everyone can rise above their circumstance and achieve success if they dedicated to and passionate about that they do."
Nelson Mandella

Thursday, December 5, 2013

French Court Supports Claims for Anxiety Flowing from Asbestos Exposure - Protests Continue - Criminal Trials Decisions Await

Photo shared from AFP (Agence France-Presse)
"Thousands stage Paris 'die-in' to protest asbestos" 12 Oct 2013

The international movement to support asbestos victims rights in France, and ultimately seek a universal ban, continues in Paris by the ANDEVA (National Association for Defense of Asbestos Victims) advocacy organization.

In September 2013 the Social Chamber of the Court of Cassation confirmed the injury of anxiety for workers exposed to asbestos and the competence of tribunal to condemn employers to compensate. It also had to comment on the injury upheaval in the lives and the responsibility of insurers such as AGS.

The French Court affirmed that damages had be paid to employees sickened by asbestos for anxiety. The Court allowed these damages for the first time in an occupational disease case.

The loss of future income was not allowed by the French Court.

This judgment was highly anticipated not only by the former employees of ZF Masson of Babcock Wanson or Ahlstrom and by thousands of others throughout France. The injured workers and their families received support from ANDEVA.

ANDEVA commented, "You have to measure the scope of this judgment: in spite of fierce resistance from employers and their lawyers that triggered a veritable barrage, the Court of Cassation confirmed and signed, sending a strong signal to businesses for the prevention, compliance with the health and lives of employees." "This fight today conducted for asbestos, will apply to other dangerous products delayed effect and particularly to carcinogens which are still exposing two million employees according to the latest statistics from the Ministry of Labour."

The advocacy movement in France for adequate compensation for asbestos workers is longstanding. ANDEVA, the asbestos workers advocacy group, who I have visited and consulted, has historically pursued judicial remedies for asbestos workers.

It has been reported that,….."Eternit produced and sold asbestos-cement products in France for 75 years – from 1922 until 1997 (the year of the French ban). For much of this time, asbestos-cement production and marketing in France were controlled by a cartel in which Eternit acted in conjunction with the French multinational Saint-Gobain (through its subsidiary Everite). The first Eternit plants were built in 1 922 at Thiant and Prouvy (twin cities in the North département) followed by factories at Vitry-en-Charollais (Paray-le-Monial, Saône-et-Loire dép), Vernouillet (Triel, Yvelines dép), Caronte (Bouches-du-Rhône dép), Saint-Grégoire (Rennes, Ille-et-Vilaine dép) and Terssac (Albi, Tarn dép). While the Prouvy and Caronte factories have been shut down, the Vernouillet site houses the head office of the Eternit holding company; the four other factories were converted (in 1996-97) to the production of non-asbestos fibro-cement."

"In 1996, ANDEVA filed, in a civil suit, a “plainte contre X” (“complaint against unknown persons”), for involuntary injuries and homicides, abstention délictueuse (willful failure to act [to protect persons in imminent danger]) and poisoning; this suit was aimed at all persons responsible for the asbestos health catastrophe: the asbestos product manufacturers, the public health and labour authorities, the medical doctors that had collaborated in the process."

ANDEVA also participates in an annual street protest to support asbestos workers' rights and advocates to ban asbestos and supports litigation for both personal injury benefits for victims and criminal charges against employers.

The recent street protest ("Die-In") in November was reported in the media, "The protesters from all over France lay down in the street outside Sorbonne University in Paris’s Latin Quarter to dramatise that asbestos exposure claims 3,000 lives per year, according to organisers." ..... "'It has been 17 years since we submitted the first complaints, and there has still not been a criminal trial,' ANDEVA vice president Francois Desriaux told AFP. 'The asbestos risk is not ancient history, it still exists today,' he said."

The criminal court cases are still pending.





In Detroit Ruling, Threats to Promises and Assumptions

Bankruptcy is utilized by employers as shields against liabilities. Self-Insurance in workers' coesation is one of those liabilities Today's post was shared by Steven Greenhouse and comes from www.nytimes.com

Someday, Detroit’s bankruptcy may well be seen as the start of an era of broken promises.
For years, cities have promised rock-solid pensions without setting aside enough money to pay for them, aided by lax accounting practices, easy borrowing and sometimes the explicit encouragement of labor unions.
Officials were counting on rich investment gains to fill the holes; unions and their retirees were counting on legal provisions — like Michigan’s Constitution — that said pensions were unassailable and that benefits would always be paid, whether through higher taxes or budget cutbacks elsewhere.
But a bankruptcy judge, Steven W. Rhodes, threw a wrench into that thinking on Tuesday, ruling that pension benefits could be reduced in a bankruptcy proceeding. The decision recast the landscape and gave distressed cities leverage to backtrack on their promises.
“Last night, as a public employees’ union leader, you went to bed thinking, ‘My workers’ pensions have special protection; I can continue to play hardball,’ ” Karol K. Denniston, a lawyer with the firm Schiff Hardin who has been advising residents of California cities on fiscal issues, said Tuesday after the judge issued his ruling. “This morning you woke up and found yourself in a new world.”
Public employees’ unions are already fighting back, though not against the chronic underfunding of their benefits. They are fighting the notion that...
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The Road toward Fully Transparent Medical Records

Privacy of medical data in the workers' compensation system does not exist. Federal portability act excluded worker's Compensation claims. In some jurisdictions, claimants are able to seek declaratory relief to shield the records. The processes costly, onerous, and incompatible with the underlining summary and remedial legislative intent of a viable Worker's Compensation program. Today's post was shared by NEJM and comes from www.nejm.org

Perspective
Jan Walker, R.N., M.B.A., Jonathan D. Darer, M.D., M.P.H., Joann G. Elmore, M.D., M.P.H., and Tom Delbanco, M.D.
December 4, 2013DOI: 10.1056/NEJMp1310132
Article
Forty years ago, Shenkin and Warner argued that giving patients their medical records “would lead to more appropriate utilization of physicians and a greater ability of patients to participate in their own care.”1 At that time, patients in most states could obtain their records only through litigation, but the rules gradually changed, and in 1996 the Health Insurance Portability and Accountability Act entitled virtually all patients to obtain their records on request. Today, we're on the verge of eliminating such requests by simply providing patients online access. Thanks in part to federal financial incentives,2 electronic medical records are becoming the rule, accompanied increasingly by password-protected portals that offer patients laboratory, radiology, and pathology results and secure communication with their clinicians by e-mail.
One central component of the records, the notes composed by clinicians, has remained largely hidden from patients. But now OpenNotes, an initiative fueled primarily by the Robert Wood Johnson Foundation, is exploring the effects of providing access to these notes.3 Beginning in 2010, at Beth Israel Deaconess Medical Center (which serves urban and suburban Boston), Geisinger Health System (in rural Pennsylvania), and Harborview Medical Center (Seattle's...
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ADAO Resource: How To Find a Doctor or Treatment Facility Specializing in Mesothelioma and Asbestos-Related Diseases

Seeking information about medical treatment concerning mesothelioma? The information made available by the ADAO makes the process less difficult, Especially during challenging moments.Today's post was shared by Linda Reinstein and comes from www.asbestosdiseaseawareness.org

Posted on December 4, 2013*Note: From the very founding of our organization, ADAO has abstained from providing any medical or legal referrals. ADAO remains an independent organization that is not influenced by outside sources, such as drug companies, law firms, or companies that manufacture or use asbestos.

Many of us can think back to the heartbreaking time when we first heard the news that a loved one had an asbestos-caused disease. “Mesothelioma – can’t pronounce it, can’t cure it,” was my devastated, personal reaction. It took me many weeks to even begin to understand the diagnosis my husband had received and find the very limited treatment options available to him.

My learning curve was steep and Alan was diagnosed before the advancement of the smart phone.

Navigating the health care system maze is complex – but it shouldn’t be. The Asbestos Disease Awareness Organization (ADAO) is committed to replacing those feelings of fear, loneliness and confusion with the knowledge that there are others who share your experience and want to support you.

We want you to have easy access to information about medical resources for asbestos-caused diseases. The National Cancer Institute has an excellent page, in English and Spanish, to answer your questions on “How To Find a Doctor or Treatment Facility...
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Charts: Why Fast-Food Workers Are Going on Strike

Today's post was shared by Mother Jones and comes from www.motherjones.com

This Thursday, fast-food workers in more than 100 cities are planning a one-day strike to demand a "livable" wage of $15 an hour. They have a point: The lowest-paid Americans are struggling to keep up with the cost of living—and they have seen none of the gains experienced by the country's top earners. While average incomes of the top 1 percent grew more than 270 percent since 1960, those of the bottom 90 percent grew 22 percent. And the real value of the minimum wage barely budged, increasing a total of 7 percent over those decades.
More of the numbers behind the strike and the renewed calls to raise the minimum wage:
Median hourly wage for fast-food workers nationwide:
$8.94/hour
Increase in real median wages for food service workers since 1999:
$0.10/hour
Last time the federal minimum wage exceeded $8.94/hour (in 2012 dollars):
1968
Change in the real value of the minimum wage since 1968:
-22%
Median age of fast-food workers:
29
Median age of female fast-food workers:
32
Percentage of fast-food workers who are women:
65%
Percentage of fast-food workers older than 20 who have kids:
36%
Income of someone earning $8.94/hour:
$18,595/year
Federal poverty line for a family of three:
$17,916/year
Income of someone earning $15/hour:
$31,200/year
Income needed for a "secure yet modest" living for a family with two adults and one child…
In the New York City area: $77,378/year
In rural Mississippi: $47,154/year
Growth in average real income of the top 1 percent since 1960:
271%
What the...
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OSHA fines Ronkonkoma contractor $460G for more safety violations

Today's post was shared by FairWarning and comes from www.newsday.com


A Ronkonkoma painting and stucco contractor is facing $460,350 in fines for safety violations, its sixth penalty since 2008, the U.S. Labor Department said Tuesday, Dec. 3, 2013.
A Ronkonkoma painting and stucco contractor is facing $460,350 in fines for safety violations, its sixth penalty since 2008, the U.S. Labor Department said Tuesday.
The fine total is the largest so far for Painting and Decorating Inc., the department said. The citation came after a March inspection by the Westbury office of the U.S. Occupational Safety and Health Administration turned up alleged violations at a work site in Manhasset. The violations were similar to those found in previous inspections, said OSHA, which is a unit of the Labor Department.
The new allegations include improperly inspected scaffolding; hazards such as missing cross braces and planks on scaffolding; a lack of fall protection for workers and a lack of protective helmets; and no protection against falling objects.
"The sizable fines proposed reflect the ongoing failure and refusal by this employer to provide basic safeguards for its employees," said Anthony Ciuffo, OSHA's Long Island area...
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Rail Safety Questions Raised After NY Train Derails

Today's post was shared by FairWarning and comes from www.thetakeaway.org

Investigators have found that the Metro-North commuter train that crashed in Bronx on Sunday—which killed four and injured more than 60 people—was speeding.
The train was travelling at around 82 miles per hour, even though a speed of 30 miles per hour or less was mandated on the stretch of curvy track the train was passing through.
In 2008, Congress passed the Rail Safety Improvement Act, which mandated that railroad companies install positive train control—a technology that automatically detects excessive speeding and other human error.
But even though the law was passed five years ago, the deadline to install positive train control isn’t for another two years.
In 2008 as a Democratic congressman representing Minnesota's 8th District, James Oberstar was a driving force behind this change as chair of the House Transportation and Infrastructure committee. He joins The Takeaway to explain why Congress pushed for the Rail Safety Improvement Act and why the deadline isn't until December 31, 2015.
Also joining the program is Stuart Silverstein, assistant editor at FairWarning.org, an investigative news organization focused on public health and safety issues. Silverstein explains why some rail companies are succeeding at installing the positive train control system while others are missing the...
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President Obama Statement on the Benefits of the Affordable Care Act

Thanks to Monica, thanks to everybody standing behind me, and thanks for everybody out there who cares deeply about this issue.  Monica’s story is important because for all the day-to-day fights here in Washington around the Affordable Care Act, it’s stories like hers that should remind us why we took on this reform in the first place.
And for too long, few things left working families more vulnerable to the anxieties and insecurities of today’s economy than a broken health care system.  So we took up the fight because we believe that, in America, nobody should have to worry about going broke just because somebody in their family or they get sick.  We believe that nobody should have to choose between putting food on their kids’ table or taking them to see a doctor.  We believe we’re a better country than a country where we allow, every day, 14,000 Americans to lose their health coverage; or where every year, tens of thousands of Americans died because they didn’t have health care; or where out-of-pocket costs drove millions of citizens into poverty in the wealthiest nation on Earth.  We thought we were better than that, and that’s why we took this on.  (Applause.)
And that’s what’s gotten lost a little bit over the last couple of months.  And our focus, rightly, had to shift towards working 24/7 to fix the website, healthcare.gov, for the new marketplaces where people can buy affordable insurance plans.  And today, the website is working well for the vast majority of users.  More problems may pop up, as they always do when you’re launching something new.  And when they do, we’ll fix those, too.  But what we also know is that after just the first month, despite all the problems in the rollout, about half a million people across the country are poised to gain health care coverage through marketplaces and Medicaid beginning on January 1st -- some for the very first time.  We know that -- half a million people.  (Applause.)  And that number is increasing every day and it is going to keep growing and growing and growing, because we know that there are 41 million people out there without health insurance.  And we know there are a whole bunch of folks out there who are underinsured or don’t have a good deal.  And we know the demand is there and we know that the product on these marketplaces is good and it provides choice and competition for people that allow them, in some cases for the very first time, to have the security that health insurance can provide. 
The bottom line is this law is working and will work into the future.  People want the financial stability of health insurance.  And we’re going to keep on working to fix whatever problems come up in any startup, any launch of a project this big that has an impact on one-sixth of our economy, whatever comes up we’re going to just fix it because we know that the ultimate goal, the ultimate aim, is to make sure that people have basic security and the foundation for the good health that they need.
Now, we may never satisfy the law’s opponents.  I think that’s fair to say.  Some of them are rooting for this law to fail -- that’s not my opinion, by the way, they say it pretty explicitly.  (Laughter.)  Some have already convinced themselves that the law has failed, regardless of the evidence.  But I would advise them to check with the people who are here today and the people that they represent all across the country whose lives have been changed for the better by the Affordable Care Act.
The other day I got a letter from Julia Walsh in California.  Earlier this year, Julia was diagnosed with leukemia and lymphoma.  “I have a lot of things to worry about,” she wrote.  “But thanks to the [Affordable Care Act], there are lots of things I do not have to worry about, like…whether there will be a lifetime cap on benefits, [or] whether my treatment will bankrupt my family…I can’t begin to tell you how much that peace of mind means...”  That’s what the Affordable Care Act means to Julia.  She already had insurance, by the way, but because this law banned lifetime limits on the care you or your family can receive, she’s never going to have to choose between providing for her kids or getting herself well -- she can do both. 
Sam Weir, a doctor in North Carolina, emailed me the other day.  “The coming years will be challenging for all of us in family medicine,” he wrote.  “But my colleagues and I draw strength from knowing that beginning with the new year the preventive care many of our current patients have been putting off will be covered and the patients we have not yet seen will finally be able to get the care that they have long needed.”  That’s the difference that the Affordable Care Act will make for many of Dr. Weir’s patients.  Because more than 100 million Americans with insurance have gained access to recommended preventive care like mammograms, or colonoscopies, or flu shots, or contraception to help them stay healthy -- at no out-of-pocket cost.  (Applause.)
At the young age of 23, Justine Ula is battling cancer for the second time.  And the other day, her mom, Joann, emailed me from Cleveland University Hospital where Justine is undergoing treatment.  She told me she stopped by the pharmacy to pick up Justine’s medicine.  If Justine were uninsured, it would have cost her $4,500.  But she is insured -- because the Affordable Care Act has let her and three million other young people like Monica gain coverage by staying on their parents’ plan until they’re 26.  (Applause.)  And that means Justine’s mom, all she had to cover was the $25 co-pay. 
Because of the Affordable Care Act, more than 7 million seniors and Americans with disabilities have saved an average of $1,200 on their prescription medicine.  (Applause.)  This year alone, 8.5 million families have actually gotten an average of $100 back from their insurance company -- you don’t hear that very often -- (laughter) -- because it spent too much on things like overhead, and not enough on their care.  And, by the way, health care costs are rising at the slowest rate in 50 years.  So we’re actually bending the cost of health care overall, which benefits everybody.  (Applause.)
So that’s what this law means to millions of Americans.  And my main message today is:  We’re not going back.  We’re not going to betray Monica, or Julia, or Sam, or Justine, or Joann.  (Applause.)  I mean, that seems to be the only alternative that Obamacare’s critics have is, well, let’s just go back to the status quo -- because they sure haven’t presented an alternative.  If you ask many of the opponents of this law what exactly they’d do differently, their answer seems to be, well, let’s go back to the way things used to be.
Just the other day, the Republican Leader in the Senate was asked what benefits people without health care might see from this law.  And he refused to answer, even though there are dozens in this room and tens of thousands in his own state who are already on track to benefit from it.  He just repeated “repeal” over and over and over again.  And obviously we’ve heard that from a lot of folks on that side of the aisle.
Look, I’ve always said I will work with anybody to implement and improve this law effectively.  If you’ve got good ideas, bring them to me.  Let’s go.  But we’re not repealing it as long as I’m President and I want everybody to be clear about that.  (Applause.) 
We will make it work for all Americans.  If you don’t like this law -- (applause) -- so, if despite all the millions of people who are benefitting from it, you still think this law is a bad idea then you’ve got to tell us specifically what you’d do differently to cut costs, cover more people, make insurance more secure.  You can’t just say that the system was working with 41 million people without health insurance.  You can’t just say that the system is working when you’ve got a whole bunch of folks who thought they had decent insurance and then when they got sick, it turned out it wasn’t there for them or they were left with tens of thousands of dollars in out-of-pocket costs that were impossible for them to pay.
Right now, what that law is doing -- (baby talks.)  Yes, you agree with me.  (Laughter.)  Right now, what this law is doing is helping folks and we’re just getting started with the exchanges, just getting started with the marketplaces.  So we’re not going to walk away from it.  If I’ve got to fight another three years to make sure this law works, then that’s what I’ll do.  That’s what we’ll do.  (Applause.)
But what’s important for everybody to remember is not only that the law has already helped millions of people but that there are millions more who stand to be helped.  And we’ve got to make sure they know that.  And I’ve said very clearly that our poor execution in the first couple months on the website clouded the fact that there are a whole bunch of people who stand to benefit.  Now that the website is working for the vast majority of people, we need to make sure that folks refocus on what’s at stake here, which is the capacity for you or your families to be able to have the security of decent health insurance at a reasonable cost through choice and competition on this marketplace and tax credits that you may be eligible for that can save you hundreds of dollars in premium costs every month, potentially.
So we just need people to -- now that we are getting the technology fixed -- we need you to go back, take a look at what’s actually going on, because it can make a difference in your lives and the lives of your families.  And maybe it won’t make a difference right now if you’re feeling healthy, but I promise you, if somebody in your family -- heaven forbid -- gets sick, you’ll see the difference.  And it will make all the difference for you and your families.
So I’m going to need some help in spreading the word -- I’m going to need some help in spreading the word.  I need you to spread the word about the law, about its benefits, about its protections, about how folks can sign up.  Tell your friends.  Tell your family.  Do not let the initial problems with the website discourage you because it’s working better now and it’s just going to keep on working better over time.  Every day I check to make sure that it’s working better.  (Laughter.)  And we’ve learned not to make wild promises about how perfectly smooth it’s going to be at all time, but if you really want health insurance through the marketplaces, you’re going to be able to get on and find the information that you need for your families at healthcare.gov.
So if you’ve already got health insurance or you’ve already taken advantage of the Affordable Care Act, you’ve got to tell your friends, you’ve got to tell your family.  Tell your coworkers.  Tell your neighbors.  Let’s help our fellow Americans get covered.  Let’s give every American a fighting chance in today’s economy.
Thank you so much, everybody.  God bless you.  God bless America.  (Applause.)

Meet the 32 Senate Republicans Who Voted to Continue LGBT Discrimination in the Workplace

Today's post was shared by Mother Jones and comes from www.motherjones.com
Louie Palu/ZUMA, Jay Mallin/ZUMA, Jeff Cook/ZUMA, Michael Reynolds/ZUMA and Jane Kelly/Shutterstock
On Thursday afternoon, the Senate passed the Employment Non-Discrimination Act (ENDA), a landmark bill that would end decades of employment discrimination against lesbian, gay, bisexual, and transgender Americans. The bill moved forward with support of 54 senators who caucus with the Democrats (Sen. Bob Casey of Pennsylvania didn't vote because he was attending to his wife's surgery) as well as votes from 10 Republicans, only a few months after the Supreme Court ruled that the government must recognize same-sex marriages. But most GOP Senators came out against it, and House Speaker John Boehner has promised to oppose the bill, which means it will likely be killed in the House.
"One party in one house of Congress should not stand in the way of millions of Americans who want to go to work each day and simply be judged by the job they do," President Barack Obama said in a statement. "I urge the House Republican leadership to bring this bill to the floor for a vote and send it to my desk so I can sign it into law."
It's already illegal for companies to discriminate against Americans on the basis of age, disability, gender, race and religion. ENDA would add sexual orientation and gender identity to the list, protecting LGBT workers from being fired or denied benefits and promotions based on their sexual identity. (An amendment pushed by Sen. Rob...
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FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare

Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices. 

The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.
 
“If the device indicates it has detected an error during a self-test the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”
 
These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. Users, who may include consumers and first responders, should contact Philips Healthcare  disclaimer icon immediately for a replacement AED unit.
 
An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
 
In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock. The notification also directed users to a Maintenance Advisory disclaimer icon.
 
The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs. 
 
In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.
 
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

….
Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.