The requirement by the FDA for post-market testing on metal-on-metal hips is a sign that the federal regulator may be finally coming to its senses over the longstanding invitation to manufacturers to escape the road of rigorous testing for some medical devices.
It’s about bloody time.
The FDA is both a regulatory body and a political body, with the majority of its power reserved for manufacturers of new drugs and new medical devices. To that end the FDA can play hardball and make a manufacturer jump through hoops until the agency is satisfied that a device or drug delivers more benefit than it does risk.
Once a device is on the market however, the FDA has pretty weak powers. A letter, such as the one sent to about 20 manufacturers of metal-on-metal hips on Friday, is about the extent of the FDA’s post-market authority.
Basically, the FDA has ordered all artificial hip manufacturers to conduct post-market testing of their devices, in light of the failure rate of various artificial hips.
However, had this testing been conducted in the first place, hundreds if not thousands of patients with problematic hips would have been spared the pain and frustration that comes with having an allegedly defective hip placed inside your body—at great expense—only to have it fail within five years of an expected 15 to 20-year lifespan.
A failed artificial hip needs, in most cases, to be replaced—along with more pain, more downtime, and more money.
At least it can be replaced…
Witness the situation over heart leads a few years ago. One brand of defibrillator lead, a wire Read the rest of this entry »
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A roundup of recent asbestos-related news and information that you should be aware of. An ongoing list of asbestos hot spots from the Asbestos News Roundup archive appears on our asbestos map.
St. Clair County, IL: Forty-one companies have been named as defendants in the latest asbestos suit to be filed in St. Clair County. Debra L. Trimble of Illinois filed the asbestos lawsuit alleging that the defendants caused her to develop lung cancer resulting from career exposure to asbestos-containing products.
In her suit, Trimble claims she was employed as a foundry worker for General Motors from 1976 until 1999. During that time, the defendants should have known of the harmful effects of asbestos, but failed to exercise reasonable care and caution for the plaintiffs’ or their deceased relative’s safety.
Trimble further alleges that as a result of her asbestos-related disease, she became disabled and disfigured, incurred medical costs and suffered great physical pain and mental anguish. Consequently, she became prevented from pursuing her normal course of employment and, as a result, lost large sums of money that would have accrued to her, the suit alleges.
Trimble is seeking a judgment of more than $100,000, plus punitive and exemplary damages of more than $100,000 and compensatory damages of more than $50,000. (madison record.com)
Jefferson County, TX: A couple from Texas have filed an asbestos suit naming nine defendant companies. In their suit, the couple claims the defendants caused the man to develop a malignant asbestos-related disease and industrial dust disease. The suit claims he worked around products manufactured by the defendant companies.
In their suit, Mr. and Mrs. Clark allege the defendant companies caused Walter Clark’s diseases because they allowed asbestos-related products to be used on their premises even though they Read the rest of this entry »
Across the US, there are thousands of lawyers who offer up their personal time to do Pro Bono Publico, from the Latin, meaning ‘for the public good’—usually shortened to ‘Pro Bono’. Many law firms now put a high value on giving back to their communities, or donating millions of hours every year to low-income people who cannot afford to pay for legal representation.
According to a survey by the American Bar Association, “at least 40 percent of low and moderate-income households experience a legal problem each year”. There is unfortunately a dearth of help available and legal aid is able to cover only about 20 percent of those who need help.
In March 2011, a survey of 200 lawyers from small and large firms commissioned by Lexis Nexis and Pro Bono Net, an organization that puts lawyers together with good causes, offers a glimpse into the motives of lawyers who pitch in to help Americans who are struggling to get through the legal system.
According to the study, “Why Lawyers Give Back: A Window into the Drivers and Barriers of Engagement in Pro Bono Work” (March 2011), an overwhelming number (75%) share their legal skills and time with deserving clients for reasons of personal fulfillment. The second largest group (43%) takes pro bono work because they believe in a particular cause and the third largest number (37%) because of an ethical obligation.
So, a profession that is often maligned as self-interested and more motivated by financial incentive than moral code, is in fact, one in which many frequently step forward because they believe it is the right thing to do.
“There are other reasons people do pro bono, but yes, I think that is accurate,” says Cristin Zeisler, who heads the pro bono department at Manatt, Phelps & Phillips. “Most of our work is commercial, but 3 to 5 percent of our work focuses on the needs of low income people and [those who are] disenfranchised.”
“We do not have mandatory pro bono,” says Zeisler. “Our lawyers do it because they want to do it. A lot of it really does come from their passion.”
Among the lawyers who are not doing pro bono work, according to the “Why Lawyers Give Back” Survey, the majority said they simply did not have time (67%) to participate in pro bono projects. The next largest group (30%) said their workload at their firms didn’t allow them to donate hours for free.
Only a quarter (26%) of the lawyers who are not doing pro bono work said they “had no interest in pro bono matters”.
In firms with pro bono departments, a great deal of effort goes into allowing lawyers to bring forward their own pro bono areas and issues of interest because that leads to the most successful efforts. At Manatt, Phelps & Phillips, Zeisler tries to match donated hours and heartfelt desires. “That’s why managing pro bono at a law firm is a full time job and I take it very seriously. You want people to help lawyers channel their passions towards an issue in a community that is really going to make a difference,” Zeisler says.
ProBono.net is an online resource for lawyers and legal aid advocates working to make a difference for low-income and disadvantaged Americans. Lexis Nexis is the world’s largest data research company that provides electronic access to legal and public records.
It’s daunting to read some of the facts and figures from the Alzheimer’s Association. Stats such as this:
In the United States, an estimated 5.4 million people are living with Alzheimer’s disease, and someone develops the disease every 69 seconds. Unless something is done, as many as 16 million Americans will have Alzheimer’s in 2050 and someone will develop the disease every 33 seconds. In 2010, 14.9 million family members and friends provided 17 billion hours of unpaid care to those with Alzheimer’s and other dementias—care valued at $202.6 billion.
Or this:
Alzheimer’s is the sixth-leading cause of death in the country and the only cause of death among the top 10 in the United States that cannot be prevented, cured or even slowed. Based on mortality data from 2000-2008, death rates have declined for most major diseases while deaths from Alzheimer’s disease have risen 66 percent during the same period.
The Baby Boomer generation hasn’t been about frailty. Since day one, they’ve had strength in numbers—able to go through life with the knowledge that—simply by those sheer numbers—they’d be the indomitable force at whatever life stage they’d be at. Which is why AARP probably uncorked some champagne once 1996 rolled around—the year the first wave of boomers became eligible to not only join the retired persons ‘club’ (senior discounts!)—but also add their collective boom to AARP’s advocacy efforts.
But lurking in the background—regardless of CNN’s display of boomer vitality presented on one of their lead stories today—is a darker side of being Boomer: Alzheimer’s.
With statistics such as those above, it’s hard to understand why, for so many of us, Alzheimer’sis someone else’s parent’s or grandparent’s disease. But as the video at top states, Alzheimer’s can happen to anyone—and 65 is the age at which things start to shift into higher gear for Alzheimer’s disease. In fact, according to the Alzheimer’s Association, the likelihood of developing Alzheimer’s doubles about every five years after age 65.
And this year, 2011, just so happens to be the year in which the first wave of Baby Boomers turn 65.
It’s a sad truth the Alzheimer’s Association has been aware of long before any public cognizance—and even now, many probably don’t have any sense of the devastating imprint Alzheimer’s is about to leave on our Boomer nation.
What doesn’t make the Alzheimer’s lottery any easier—for those who may be afflicted and for their loved ones—is news like that which was reported at NPR.org this past week. It’s the story of Aurora Navas, who just happened to develop Alzheimer’s disease. As the demands to care for her increased, her family had to turn to assisted care. They trusted the assisted care facility to care for Aurora. Instead, she wandered out of the facility to a nearby lake, and drowned in eighteen inches of water.
Elder care abuse, nursing home neglect, assisted care negligence appear to be more common than we’d like to be aware of. The NPR article mentions a joint study done by The Miami Herald and WLRN which focused on assisted care facilities in Florida. The findings were bleak: at least 70 questionable deaths found in FL assisted living facilities in the past decade.
And, sadly, that number—and not just in Florida—stands to grow given the aforementioned strength in numbers the Boomer generation presents, particularly when combined with the lack of awareness Alzheimer’s patients experience.
As caregivers, there are signs to be aware of when it comes to elder abuse or neglect. Please read our information on the signs of nursing home abuse—and what to do about it if you suspect it. There are lawyers who specialize in elder care abuse and they are there to help you.
For information on Alzheimer’s disease diagnosis, treatment options, statistics, information and advocacy, I can’t urge you enough to visit the Alzheimer’s Association website at alz.org. And be sure to check out the Celebrity Champion webpages where Anthony Anderson, Katie Armiger, Wayne Brady, Coach Frank Broyles, Kate Burton, Dominic Chianese, Dwight Clark, Dear Abby, Diamond Jim, Olympia Dukakis, Hector Elizondo, Emerson Drive, Shelley Fabares, Jack Ford, Vivica A. Fox, Soleil Moon Frye, Peter Gallagher, Victor Garber, Phyllis George, Leeza Gibbons, John Glover, Bob Goen, Bryant Gumbel, Elisabeth Hasselbeck, Emma Mae Jacob, Matt Jenkins, Rafer Johnson, Lainie Kazan, Ricki Lake, The Marshalls, Kathy Mattea, Natalie Morales, Terry Moran, Kate Mulgrew, Terrell Owens, Stephen Pasquale, David Hyde Pierce, Tony Plana, Sarah Polley, Ahmad Rashad, John Runyan, Rex Ryan, Molly Sims, Jean Smart, Brent Spiner, April Taylor, Lea Thompson, Tracie Thoms, Dick Van Dyke, Anna Wilson and Whiskey Falls have lent their voices, their passion and their commitment to the fight against Alzheimer’s.
Please share this post with all those you love.