Articles Posted in Medical Device Safety

Blausen_0601_LaparoscopicGastricBanding-300x300They once got a ton of hype with radio, TV, and print ads, as well as billboard campaigns by proponents who later proved to be nothing less than sketchy. But the much-touted lap-band weight surgeries have fallen out of favor. The number of the procedures performed annually has nose-dived.

Researchers, based on a longer view, are finding that, among bariatric weight-loss options, lap-band surgeries offer some of the poorest results and result in frequent added procedures—at big costs, both economic and to disappointed, suffering patients.

Vox, the online news site, deserves credit for pulling together a painful review of what once was the most common way for overweight Americans, mostly women, to tackle one of the nation’s epidemic conditions: obesity.

defib-st-judeThe serious, slowly disclosed problems of a manufacturer and its implanted heart defibrillators may offer more needed cautions to Food and Drug Administration critics who want regulators to rush the oversight of drug and medical device makers and make the agency more welcoming to big business.

St. Jude Medical, the New York Times has reported, has received a written rebuke that the FDA has hit the wall with the company and wants it to deal with its product problems. The agency says it is fed up because the company has dawdled for years in letting patients, as well as its senior management and medical advisory board know that it long has experienced major woes with its heart devices batteries.

St. Jude has been forced to issue recall notices on hundreds of thousands of its defibrillators. Hundreds of cases have been reported in which their batteries died unexpectedly. Dozens of patients have suffered “adverse effects,” and at least two deaths have been attributed to device failures.

23andMetest-300x229Federal regulators have reversed themselves and approved a company’s controversial plan to sell direct to customers saliva-based tests that can predict their genetic risk for diseases like Alzheimer’s and Parkinson’s.

Officials of the federal Food and Drug Administration emphasized that the tests cannot show conclusively if individuals will develop conditions for which they may have genetic risk. They said any health test results should be discussed fully with doctors.

The FDA said it would keep close tabs on the online-order products of  23andMe, which previously had sought to market its saliva tests not only for consumers’ genealogies but also for their health interests. The FDA slapped down the firm’s first foray into health measurements:  23andMe in 2013 had charged $99 for a test that it claimed gave information, genetic and otherwise, on 240 conditions and traits. Regulators halted those tests, requiring 23andMe and others in the field  to prove their products’ accuracy and to clarify that users understood what they were paying for and any test data.

cdc-logo-300x226When it comes to the nation’s health, the Trump Administration and the GOP-dominated Congress seem determined to prove they know how to do penny-wise and pound-foolish. They’re amply demonstrating this with proposed slashes in the nation’s basic budget for public health. They’re calling for a $1 billion cut for the Centers for Disease Control and Prevention, notably in the agency’s funding to combat bioterrorism and outbreaks of disease, as well as to battle smoking and to provide critical medical services like immunizations. Their target is the Prevention and Public Health Fund, set up under the Affordable Care Act, aka Obamacare. With the ACA under fire by partisans who want to repeal and replace it, the fund was already imperiled. GOP lawmakers, determined to cut domestic spending, seem disinclined to come up with substitute sums.

Andy Harris, a Maryland Republican congressman, physician, and House appropriations health subcommittee member, has been quoted as calling the public health money, “a slush fund.” He argued that, “It’s been used by the secretary [of health and human services] for whatever the secretary wants. It’s a misnomer to call it the Prevention and Public Health Fund, because it’s been used for other things, and it’s about time we eliminated it.”

The Obama Administration did embarrass Congress by tapping the fund to provide emergency aid last summer to Florida, Puerto Rico, Hawaii, and other states battling tropical infections, including Zika and dengue fever. Congress took a long recess vacation, as states clamored for help for mosquito eradication and vaccine development to deal with Zika, a virus that can cause severe birth defects and other harms.

https://www.protectpatientsblog.com/wp-content/uploads/sites/69/2016/09/Food_and_Drug_Administration_logo.svg_-300x129.pngTo hear some powerful proponents tell it, Uncle Sam needs to really hurry up the government’s approval of drugs and medical devices. He’s got to make oversight over them easier, lighter, and less complex.

But consider just some of the health news in recent days:

skepticism-image-197x300At one point, medical experts recommended that physicians aggressively treat patients 60 and older so the top number of their blood pressure readings ran as close as possible to 140. Maybe not so, anymore. For a while, physicians were told to treat patients so their “good cholesterol” increased significantly. But maybe this approach doesn’t protect against heart disease after all. Pediatricians once warned parents to protect newborns by not exposing them to certain allergens, especially peanuts. If you haven’t had your head buried in the sand, that counsel, of course, has just changed 180 degrees.

Thanks are due to Aaron E. Carroll, a pediatrician, health research and policy expert, and columnist with the New York Times “Upshot” feature, for reminding — yet again, as repetition is the Mother of Learning — that medical news must be taken in by patient-consumers with a “dose of healthy skepticism.” This he says is especially true about reports on nutrition.

I’ve written about the harms that result from hype and the many, sometimes dramatic reverses in health and medical news. I’ve pointed out that there are accessible resources, such as the excellent healthnewsreview.org, to watchdog coverage of medical science and so-called advances. I’ve suggested that patient-consumers look closely at key elements in research stories, including how the work was done, how long the study ran, whether its data is visible and if it was published in a reputable medical journal. This will help savvy readers look askance, even at pieces in quality news sites — such as recent articles touting turmeric or eating lots of hot peppers.

fireextinguisher-211x300They’re likely jammed into many of the toys and electronic gadgets that overflowed the house during the holidays. But they’ve also been linked to sufficient fires that products have been recalled because of them, and some devices with them have even been banned in the nation’s skies. Now federal regulators are warning hospitals and doctors’ offices to beware, too: Their many battery-laden medical carts may burst into flames or explode.

The federal Food and Drug Administration has written to caregivers nationwide with a new caution that, within the last three years, it has received a dozen reports of “smoke, fire, melting batteries, burning, and other hazards” with medical carts. No injuries have been recorded but facilities have been evacuated due to smoke and fire hazards from cart blazes or smoldering, the FDA says. The rolling stations have grown increasingly common so staffers can conveniently dispense medication, or carry equipment related to colonoscopes, ultrasound, and anesthesia machines.

They’re also prized because their electrical sources—lead acid or increasingly lithium batteries—pack the power needed, they’re portable, convenient, and they’re long lasting. But those batteries also can generate a lot of heat, and they have proven problematic in other uses.

VPJoeBiden_PresidentObamaPresident Obama is expected to sign the $6.3 billion 21st Century Cures Act, capping a rare, multi-year, bipartisan push to significantly improve the nation’s health care. The Senate, with Vice President Biden presiding and winning salutes from political colleagues and patient advocacy groupsapproved the act 94-5.

Proponents say it has many benefits to go around, as I’ve written, providing:

  • a $4.8 billion boost to the National Institutes of Health to support an array of innovative research in its facilities, as well as at universities, medical schools, academic medical centers, and major hospitals;

fda hipThe pain and suffering that a flawed medical device can cause can last a long time. A Dallas jury provided a timely reminder of that, deciding six California plaintiffs should be paid more than $1 billion for the harm they suffered because of metal-on-metal hip replacement hardware made by Johnson & Johnson’s DePuy Orthopedics unit.

The Californians proved to jurors that they suffered tissue death, bone erosion, and other at times excruciating injury due to the faulty Pinnacle hip replacement product, which they said had been promoted as longer lasting and less risky than other alternatives. Jurors also heard that DePuy knew the products were defective and failed to warn patients.

Johnson & Johnson said it had acted appropriately and believed the verdict, which came in one of more than 8,000 Pinnacle-related lawsuits in Texas alone, would be overturned on appeal due to what the company said were errors by the presiding judge.

US_Congress_02It’s almost 1,000 pages,   culminates at least three years of work, and provides a $6.3 billion boost for an array of health-related agencies and initiatives. Will the U.S. Senate join the House in bipartisan passage of the 21st Century Cures Act, a sweeping measure that some say could affect American health care as much as the Affordable Care Act aka Obamacare?

After the bitterly divisive presidential campaign, House members surprised many with their swift consideration of the health funding bill, which passed 392-26. Congressional leaders then crowed about how they can work together and how the legislation will help. The act now has moved to the Senate for consideration. Senators, notably Massachusetts Democrat Elizabeth Warren, have been far more critical of components of the measure, particularly how Big Pharma and device-makers may benefit.

I’ve written how Congress, around this time last year, provided holiday cheer by approving the framework of the 21st Century Cures Act, an omnibus bill that took a year for funding details to get worked out. Because the legislation covers so many health areas and still must be acted on by the Senate and signed by the president, it still needs wary watching. Lobbyists for many different causes already have had a field day on this bill, and they will continue to do so.

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