WASHINGTON — The Food and Drug Administration warned doctors Wednesday not to use compounded drugs from a Texas specialty pharmacy due to potential risks of contamination. The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals’ plant in Temple, Texas. The inspections revealed production problems in several drug lots that were supposed to be sterile. “Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, an official in the FDA’s drug center. At the behest of regulators, Unique Pharmaceuticals has recalled all non-expired, sterile products distributed across the U.S., including a fluid used to clear mucus in patients with respiratory conditions. The company has also halted production of all other sterile drugs, which are generally solutions administered via injection or intravenous infusion. A spokesman for the company said it continues to produce other forms of drugs that do not require sterile conditions. “We are diligently working to address FDA’s concerns noted before the recall,” said David Shank, in a statement. “We have commissioned third-party independent experts to address those concerns and ensure the safety of our compounded preparations for our customers.” Shank added that the recall could contribute to shortages of medicines already in short supply. The FDA said in a statement it is not aware of any illnesses linked... |
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(c) 2010-2025 Jon L Gelman, All Rights Reserved.
Showing posts with label Johnson. Show all posts
Showing posts with label Johnson. Show all posts
Wednesday, July 23, 2014
FDA warns of compounded drug recall by Texas firm
Saturday, November 30, 2013
Hip Replacement Lawsuit: ASR Settlement ($2.5 Billion) Benefits Announced
The settlement terms of the ASR HIp Implant lawsuit have been announced:
The ASR Settlement provides for three basic areas of compensation.
The first is a Base Payment to all ASR Claimants (XL and resurfacing) who have undergone a revision surgery, removing the
acetabular cup, prior to August 31, 2013.
The second is for Claimants who have undergone a revision surgery in both their left and right hips (Bilateral Claimants).
The third addresses patients who have suffered a variety of medical complications following a revision surgery (Extraordinary Injury Fund).
In addition, the Settlement provides for the resolution of healthcare insurance liens for
medical costs that are directly associated with the revision surgery, at no additional cost to the
claimant.
Click here to read the complete press release issued by the Settlement Oversight Committee
Click here to read about the lawsuit.
The ASR Settlement provides for three basic areas of compensation.
The first is a Base Payment to all ASR Claimants (XL and resurfacing) who have undergone a revision surgery, removing the
acetabular cup, prior to August 31, 2013.
The second is for Claimants who have undergone a revision surgery in both their left and right hips (Bilateral Claimants).
The third addresses patients who have suffered a variety of medical complications following a revision surgery (Extraordinary Injury Fund).
In addition, the Settlement provides for the resolution of healthcare insurance liens for
medical costs that are directly associated with the revision surgery, at no additional cost to the
claimant.
Click here to read the complete press release issued by the Settlement Oversight Committee
Click here to read about the lawsuit.
….
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.
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Saturday, November 23, 2013
November 22, 1963 – A Personal Reflection and Alternative History If JFK Had Lived
Today's post is shared from Jay Causey, Esq. of the Washington State Bar.
I recall only a sense of numbness during the long walk back to the main campus in New Haven, Connecticut from an outlying athletic field where the Yale-Harvard freshman football game had been going on that Friday. It had been eerily quiet in the stands for 30 minutes or so before the final announcement, with small transistor radios pressed to the heads of many as events unfolded in Dallas. Then, but for a random police siren with no apparent purpose, there was mostly silence as people walked slowly away.
1963 was a dramatically different time in the perception of the general public about what government could, or should, do. I had gone to Yale imbued with the dynamic challenge of the inaugural speech in January of 1961 – “Ask not what your country can do for you; ask what you can do for your country.” I envisioned a potential State Department career, so I loaded up with Russian language, political science, and Russian and Eastern European history in my freshman year. It was a real and palpable sense of mission experienced by many of us in that period that I’ve never quite seen again among similar age groups in the aftermath of presidential elections, even Barack Obama’s.
I hope that in the not distant future a large cohort of 17 and 18 year-olds will get to experience the same exhilarating inspiration and sense of purpose about the governance of our country that I felt for too brief a time over fifty years ago.
In hindsight, and with all we now know about John Kennedy’s presidency behind the scenes, it’s perhaps easy to deride the level of enthusiasm and inspiration for change and service to country that a huge number of 17 and 18 year-olds had at the time. But for me, and I think many, November 22, 1963 was – stealing from Don McLean’s American Pie – the “day the political music died.” With the loss of what the Kennedy “magic” had inspired, I lost the drive sometime later in my freshman year, and wandered off into an American history major, and then to law school with no particular purpose in mind. I’ve been a political junkie since I was 11, and while still engaged in politics for fifty years following JFK’s death, it’s never felt the same.
Surfing the internet, you can find quite a number of so-called “alternative histories” – books and articles by historians and political analysts playing out what might have been the course of American history if Kennedy had not been assassinated. Most of these focus on what would have happened with Vietnam, the civil rights movement, the rise of the counterculture, etc., with differing conclusions. I have a longer view about how JFK’s death, in my view, likely affected the next generations right up to the current era. Some of those who have speculated about the future, had President Kennedy not died, haven’t even lived through the entire period, as I have. Since I’m pretty well-read on Vietnam and our history from the mid-60’s through the 70’s, I’ll take my shot.
Many think that because Kennedy was, nominally, a “hawk” in the early period of our Vietnam intervention, he would have continued to engage our country in that misadventure — that we would have experienced involvement on a scale not much different than what occurred under President Johnson, since the same so-called “best and the brightest” of the Kennedy administration would still have been forming policy. I conclude differently. One core belief of Kennedy’s was that American troops would not be fighting on the ground, contrary to the sabre rattling plans of the Joint Chiefs of Staff. JFK’s people had essentially faced the Chiefs down in the Cuban missile crisis of October 1962, when they were pounding the table for invasion and nuclear strikes. And I think with Kennedy controlling Secretary of Defense Robert McNamara, in a way Johnson really couldn’t, with his prior experience holding back the Chiefs, and with his ability to evolve in his thinking on critical matters, we would have de-escalated our involvement in Vietnam in his second term. (Like Johnson did, JFK would have easily swamped Barry Goldwater in the 1964 election.) I believe as the situation in Vietnam eroded, Kennedy would have sided with the opinion of those in his kitchen cabinet vigorously counseling against increasing American troops on the ground, and that this would have happened well before Walter Cronkite’s famous pronouncement in March of 1968, after seeing Vietnam first hand, that the best we could achieve there was a stalemate, faced with an unwinnable war.
So what’s the point of going through the above “alternative history?” Without the nation being mired in Vietnam in 1968, without an incumbent president consequently withdrawing from another term, and without the disarray of the Democrats due to all of the above, Richard Nixon would not likely have made his comeback and become president. If no Nixon, then no Watergate, and no resulting miasma created by the implosion of the executive branch, the final degradation of which being President Ford’s unconditional pardon of Nixon for his “high crimes and misdemeanors.”
By this point in the mid 70’s, the American public was pretty exhausted by the seeming incompetence and venality of its government and the deceits of the Vietnam debacle then coming to light, and had become largely cynical about what the Beltway-driven federal government could do. A fairly feckless administration under President Carter — a man of enormous intellect but who would not likely have risen to national prominence as a viable “outside the Beltway” candidate if the table had not been set by the prior eight years — did not help.
During the 70’s, as Watergate dragged the national psyche into the dumpster and we watched the final collapse of Saigon, as the last helos lifted off the U.S. embassy, there was a sense we’d lost our “mojo,” our “toughest kid on the block” status. In this environment arose a hardened right wing arguing, as many still do, that we failed the troops by not letting them “win the war,” and that, overall, government was the problem, not the solution to any problems. Of course, the concept of the Vietnam conflict being winnable was, and always has been, an absurdity under the lens of cogent military and historical analysis, but this thesis became a driving force in getting the U.S. military back to a supposed position of supremacy in subsequent years, and the consequential hemorrhaging of the national budget. More importantly, the “we” that government had traditionally been seen as – spearheading huge national projects – was increasingly replaced in societal hierarchy by the “I” of the supposedly heroic, self-made man or woman, whose success was all their own and which benefitted society more than any collective effort of the people.
Fifty years ago there was consensus among even the most diametrically opposed politicians from opposing political parties that a fully functioning government was an absolute requirement for the country and our democratic processes.
Cue the rise of Reagan, and Reaganism, which offered the comfort of a new feel-good, Hollywood-like “Morning in America” with the iconography of the mythical cowboy of the American west leading us out of our national torpor. As Reagan intoned: “The eight scariest words you’ll ever hear are: ‘I’m the government and I’m here to help’.” The celebration of the “I”, and the demotion of “we the people” begins with Reagan, as does the inculcation in at least a generation of younger Americans the precept that government can’t, and shouldn’t, interfere with the unfettered functioning of the “free market” (except for the gargantuan outlay for national defense). The political philosophy Reagan, his staff and enablers embraced and the his administration’s policies jump-started the serious erosion of government controls on business and industry, the rampant growth of corporatism and financialization of the economy, and the dismantling of the middle class that continues today. “Greed was good,” it was encouraged by policy, and made many of the “I”s rich beyond comprehension, as they produced nothing but their own wealth.
Economists date the stagnation of the middle class beginning about the time of Reagan, when wages for working Americans flattened and are today barely above where they were then, in constant dollars. Reagan’s firing of the air traffic controllers in 1981 emboldened a broad attack on organized labor that has continued for over thirty years. The decline of the middle class is directly attributable to the decline of organized labor, its former bulwark, now down to 8-9% of the workforce from well over 30% when I began my practice of workers’ compensation in 1977. The spread of “right to work” laws (for lower wages) has continued since the Reagan years. And over the last thirty years wealth has become concentrated in a small sector of the population to an extent not seen since the era of the Robber Barons.
Would all of this have happened if the country had not gone through the post-JFK assassination turmoil? Perhaps some of it was inevitable. But I think the post-Kennedy era demonization of the role of government in a democracy with a complex market economy has had a far more profound effect on where we find ourselves today than would have happened, absent the assassination of 1963 and its aftermath.
And what has all of that bred in today’s politics? The rise of “leaders” on the fringes of the far right so dedicated to the proposition that government is trampling freedoms secured by the founding fathers that they will ensure it doesn’t work by any means necessary. With galactic ignorance of our history, and spewing scripted sound bites of misinformation on any topic, they come to Washington not to govern but to dismantle government. But while the extremes they advocate are largely unimaginable even by their political forbearers on the right, their roots are squarely in the anti-government philosophy that erupted on such a wide scale three decades ago.
Fifty years ago there was consensus among even the most diametrically opposed politicians from opposing political parties that a fully functioning government was an absolute requirement for the country and our democratic processes. The arguments were principally about which processes, priorities and methodologies to be used, not whether the government was going to run. Arguments, debates, and analysis of government policies and process were largely substantive and advocated by legislators who mostly knew what they were talking about, not spouting talking points fed to them by media spinmeisters.
Would we still have some semblance of that today with a different fifty-year history after 1963? You decide. I’ve personally come to believe our history, and where we find ourselves in 2013, would be different – and better. I hope that in the not distant future a large cohort of 17 and 18 year-olds will get to experience the same exhilarating inspiration and sense of purpose about the governance of our country that I felt for too brief a time over fifty years ago.
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Friday, November 22, 2013
Johnson & Johnson hip implant settlement price could soar above $4 billion
A settlement Johnson & Johnson finalized yesterday over faulty hip implants could be worth more than the initial $2.5 billion price.
Johnson & Johnson agreed to pay at least $2.47 billion to settle thousands of lawsuits over its recalled hip implants, lawyers for the company and patients told a judge in outlining an accord that may be worth more than $4 billion. The agreement would resolve about 8,000 U.S. suits against J&J’s DePuy unit brought by patients who have already had artificial hips removed, Susan Sharko, one of the company’s lawyers, told U.S. District Judge David Katz yesterday in Toledo, Ohio. The company will pay an average of about $250,000 for each surgery and cover related medical costs, Sharko said. “The settlement provides compensation for eligible patients without the delay and uncertainty of protracted litigation,” Andrew Ekdahl, worldwide president of DePuy Synthes Joint Reconstruction said in a statement. The settlement, which doesn’t require the judge’s approval, is the second multibillion-dollar accord this month for J&J, the world’s largest seller of health-care products. The company, based in New Brunswick, New Jersey, agreed Nov. 4 to pay $2.2 billion to resolve criminal and civil probes into the marketing of... |
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Friday, November 15, 2013
Report: Johnson & Johnson could settle hip replacement lawsuits for $4 billion
Sources told The New York Times Tuesday that the tentative plan would include patients who’ve already had the devices — Articular Surface Replacements — removed and replaced with something different.
Under the deal, each patient would receive about $350,000 on average in compensation. The $4 billion settlement would be one of the largest payouts for medical device product liability claims, the Times noted. But the final cost could increase, depending on how many claimants already implanted with the devices end up having operations to replace them in the future, the sources told the newspaper. DePuy Orthopaedics, a subsidiary of Johnson & Johnson, recalled the ASRs in 2010. Since then, more than 10,000 people have sued in state and federal courts in the United States. The metal-on-metal replacement began to fail soon after implantation, as opposed to plastic and metal hip implants. Those typically last 15 years or more. With the DePuy replacement, metal can flake off into the body and cause tissue and bone damage. From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com. |
….
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.Related articles
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Friday, November 8, 2013
Lawyer recalls first meeting with woman who started Risperdal litigation
Brian McCormick remembers meeting Victoria Starr back in 2007 when he first started working for Sheller P.C.
The Oregon woman had approached the Philadelphia law firm about three years prior about filing a qui tam lawsuit on behalf of the U.S. government against the makers of the antipsychotic drug Risperdal.”
McCormick’s law firm filed Starr’s qui tam suit in April 2004, three months after the woman quit her job. She had begun working for Janssen in about 2001. On Monday, Johnson & Johnson announced that it would be paying more than $2.2 billion to resolve civil and criminal claims relating to allegations that the company marketed Risperdal, a drug primarily designed to treat bi-polar disorder and schizophrenia, for uses other than those approved by the Food and Drug Administration. The pharmaceutical manufacturer will pay $1.673 billion to resolve the allegations of off-label marketing for Risperdal and sister drug Invega, the resolution marking the largest involving a single drug in U.S. history, and the third-largest healthcare fraud settlement involving one company, according to the U.S. Attorney’s Office for the Eastern District of Pennsylvania. The massive settlement that resulted from a... |
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Tuesday, November 5, 2013
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigatio
Today's post is shared from justice.gov
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists\Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists\Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.
Friday, October 4, 2013
Jury weighs talcum powder-cancer link
Talc has been considered a potentially carcinogenic substance.Tody's post is shared from argusleader.com
A jury has been asked to decide whether a Sioux Falls womans ovarian cancer was caused by her use of talcum-based body powder. Deane Berg, 56, sued Johnson & Johnson in 2009, saying her 30-year use of the companys products for feminine hygiene caused her illness and that the products should have carried warning labels. Bergs trial began almost two weeks ago in U.S. District Court in South Dakota. Jurors heard testimony from eight expert witnesses who sparred over decades of medical research on the topic and over the meaning of the talc found in Bergs cancer tissue. Berg, whose cancer is in remission, wants jurors to award damages for medical expenses and punitive damages for failing to warn the public. The company wants jurors to reject the notion that the mineral, which is used in toothpaste, chewing gum and aspirin, carries any real danger for consumers. During closing arguments Thursday morning, Bergs lawyers said talcum-based powders should carry a warning that notes the association between their use and increased risk of ovarian cancer. Berg learned of the possible link after her diagnosis in 2006, from a brochure she was offered at Sanford USD Medical Center. Studies dating as far back as 1971 have found an association. The International Agency For Research on Cancer lists talc as a 2B substance, meaning possibly carcinogenic to humans. Condom manufacturers stopped using the mineral in 1996, and a Johnson & Johnson subsidiary ceased using it in diaphragms that same... |
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Tuesday, September 24, 2013
Use Only as Directed
During the last decade, more than 1,500 Americans dieda fter accidentally taking too much of a drug renowned for its safety:acetaminophen, one of the nation’s most popular pain relievers.
Acetaminophen – the active ingredient in Tylenol– is considered safe when taken at recommended doses. Tens of millions of people use it weekly with no ill effect. But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver. Davy Baumle, a slender 12-year-oldwho loved to ride his dirt bike through the woods of southern Illinois, died from acetaminophen poisoning. So did tiny five-month-old Brianna Hutto. So did Marcus Trunk, a strapping 23-year-old construction worker from Philadelphia. The toll does not have to be so high. The U.S. Food and Drug Administration has long been aware of studies showing the risks of acetaminophen – in particular, that the margin between the amount that helps and the amount that can cause serious harmis smaller than for other pain relievers. So, too, has McNeil Consumer Healthcare, the unit of Johnson & Johnson that has built Tylenol into a billion-dollar brand and the leader in acetaminophen sales. Yet federal regulators have delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen overdose,which the agency calls a “persistent, important public health problem.” The FDA has repeatedly deferred decisions on consumer protection seven when they were... |
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Friday, September 13, 2013
Drive Safely Work Week
Welcome to Drive Safely Work Week (DSWW) 2013— Gear Up For Safe Driving: Mind • Body • Vehicle. This year's campaign takes a holistic approach to safe driving that highlights how being at your physical and mental best—along with the "health" of your vehicle—are all connected in making us safer drivers. Among other things, the campaign materials cover:
In the U.S. alone, employers have the opportunity to directly reach more than half of the driving population—even more when information is extended to employee family and community members. Working together, we can significantly reduce the number of traffic crashes and injuries that impact our workforce, members of our families and communities worldwide. Thank you for downloading the 2013 DSWW campaign. We appreciate your partnership with us to help make a difference in the lives of people around the world. Safe travels, Sandra Lee NETS Chair Director, Worldwide Fleet Safety Johnson & Johnson |
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